A Phase 2 interventional study of Avacopan and Avacopan Matching Placebo in C3 Glomerulopathy (C3G), sponsored by Amgen. Completed at 45 sites in 11 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by Amgen · Phase 2, Interventional, and Treatment
Among 15 studies in Glomerulonephritis, Membranoproliferative with a site in United States — 1 open to participants now, 2 under way, 2 of them phase 3. Glomerulonephritis, Membranoproliferative · United States.
Among the 15 studies in Glomerulonephritis, Membranoproliferative with a site in United States, this one is the 4th largest by enrollment, is one of 2 that started in 2017, is one of 7 in phase 2, and was the 8th registered.
33 studies on the registry are indexed under Glomerulonephritis, Membranoproliferative; 10 are open to participants now.
Browse Glomerulonephritis, Membranoproliferative studies →1 of the 15 studies in Glomerulonephritis, Membranoproliferative with a site in United States is open now. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in United States, Argentina, Brazil and 14 more countries
Ages 12–100
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 9 Glomerulonephritis, Membranoproliferative studies recruiting now, 5 set no upper age limit and none stop at 75 or younger; 5 take children under 18; 1 takes healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 57 is above the median of 22 across 26 interventional studies indexed under Glomerulonephritis, Membranoproliferative.
Median enrollment 13 across the 15 interventional studies. Of the 11 that completed or were terminated, 8 (73%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 15 have an industry lead sponsor. The 10 most frequent:
Amgen is the lead sponsor of 1,047 studies on the registry; 51 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 166 (67%) have results posted.
Amgen has 1 study filed under Glomerulonephritis, Membranoproliferative — fewer than ten, so there is no comparison to draw.
1 of the studies in Glomerulonephritis, Membranoproliferative with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05809531Phase 3Apellis Pharmaceuticals, Inc.An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis | 2027-07 |
Add it to your calendar (.ics) → With an account.
Among the 15 studies in Glomerulonephritis, Membranoproliferative with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The aim of this trial is to evaluate the effect of avacopan treatment on renal disease activity in patients with complement component 3 glomerulopathy (C3G). Funding Source - FDA OOPD
C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD) and C3 glomerulonephritis (C3GN). There is no approved treatment for patients with C3G.
This is a randomized, double blind, placebo controlled Phase 2 study to evaluate the safety and efficacy of avacopan (CCX168) in patients with C3G. Patients receive avacopan 30mg or matching placebo orally twice-daily. The placebo-controlled treatment period is 26 weeks (182 days). This will be followed by 26 weeks during which time all patients will receive avacopan (results for this second period will be reported in due course in a follow-up publication). Thereafter, all patients will be followed for eight weeks (56 days) without study drug treatment. The primary objective is to evaluate the efficacy of avacopan compared to placebo based on histologic changes in kidney biopsies taken at baseline and after 26 weeks of treatment. The primary endpoint will be based on the percent change from baseline in the C3G Histologic Index for disease activity.
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
-proven C3G, either DDD or C3GN, with or without a renal transplant, and with the following observations upon renal biopsy taken within 12 weeks prior to screening or during screening:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Drug: Avacopan
Matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Drug: Avacopan Matching Placebo
Orally administered
Also known as: CCX168
avacopan matching placebo
Also known as: placebo
Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Subjects With Elevated C5b-9
Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement. C3G=C3 glomerulopathy
Time frame: Week 26
Percent Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Combined C5b-9 Strata
Percent change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement. C3G=C3 glomerulopathy \* Multiple Imputation: Missing Week 26 values are imputed using the regression method to create 100 complete datasets.
Time frame: Week 26
Proportion of Subjects Who Have a Histologic Response Defined as a Decrease (Improvement) in the Biopsy-based C3G Histologic Index for Activity of at Least 35% From Baseline to 26 Weeks - Subjects With Elevated C5b-9
Proportion of subjects who have a histologic response defined as a decrease (improvement) in the biopsy-based C3G Histologic Index for activity of at least 35% from baseline to 26 weeks - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement. C3G=C3 glomerulopathy
Time frame: Week 26
Proportion of Subjects Who Have a Histologic Response Defined as a Decrease (Improvement) in the Biopsy-based C3G Histologic Index for Activity of at Least 35% From Baseline to 26 Weeks - Combined C5b-9 Strata
Proportion of subjects who have a histologic response defined as a decrease (improvement) in the biopsy-based C3G Histologic Index for activity of at least 35% from baseline to 26 weeks - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement. C3G=C3 glomerulopathy
Time frame: Week 26
Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Subjects With Elevated C5b-9
Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease chronicity over the placebo-controlled treatment period - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. C3G Histological Index for Disease Chronicity Scores can range from 0 to 10. A decrease indicates improvement. C3G=C3 glomerulopathy
Time frame: Week 26
Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Combined C5b-9 Strata
Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease chronicity over the placebo-controlled treatment period - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. C3G Histological Index for Disease Chronicity Scores can range from 0 to 10. A decrease indicates improvement. C3G=C3 glomerulopathy
Time frame: Week 26
Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9
The percent change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population.
Time frame: Week 26
Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata
The percent change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population.
Time frame: Week 26
Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9
The change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population.
Time frame: Week 26
Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata
The change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population.
Time frame: Week 26
Percent Change From Baseline Over 26 Weeks in UPCR in Patients With Abnormal UPCR at Baseline - Subjects With Elevated C5b-9
Percent change from baseline Over 26 Weeks in UPCR in patients with Abnormal UPCR at Baseline (\>= 0.15 g/g) - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. LSM=Least Squares Mean; UPCR = Urine Protein : Creatinine Ratio
Time frame: Week 26
Percent Change From Baseline Over 26 Weeks in UPCR in Patients With Abnormal UPCR at Baseline - Combined C5b-9 Strata
Percent change from baseline Over 26 Weeks in UPCR in patients with Abnormal UPCR at Baseline (\>= 0.15 g/g) - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. LSM=Least Squares Mean; UPCR = Urine Protein : Creatinine Ratio
Time frame: Week 26
Percent Change From Baseline Over 26 Weeks in Urinary MCP-1 - Subjects With Elevated C5b-9
Percent change from baseline over 26 weeks in urinary MCP-1: creatinine ratio - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. LSM=Least Squares Mean; MCP-1=Monocyte Chemoattractant Protein-1
Time frame: Week 26
Percent Change From Baseline Over 26 Weeks in Urinary MCP-1 - Combined C5b-9 Strata
Percent change from baseline over 26 weeks in urinary MCP-1: creatinine ratio - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. LSM=Least Squares Mean; MCP-1=Monocyte Chemoattractant Protein-1
Time frame: Week 26
Change From Baseline Over 26 Weeks in EQ-5D-5L Health Scale VAS and Index Score - Subjects With Elevated C5b-9
Change from baseline over 26 weeks in EQ-5D-5L Health Scale VAS and Index Score - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).
Time frame: Week 26
Change From Baseline Over 26 Weeks in EQ-5D-5L Health Scale VAS and Index Score - Combined C5b-9 Strata
Change from baseline over 26 weeks in EQ-5D-5L Health Scale VAS and Index Score - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).
Time frame: Week 26
Change From Baseline Over 26 Weeks in SF-36 v2 - Subjects With Elevated C5b-9
Change from baseline over 26 weeks in SF-36 v2 - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. SF-36v2: Medical Outcomes Survey Short Form-36 version 2. SF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).
Time frame: Week 26
Change From Baseline Over 26 Weeks in SF-36 v2 - Combined C5b-9 Strata
Change from baseline over 26 weeks in SF-36 v2 - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. SF-36v2: Medical Outcomes Survey Short Form-36 version 2. SF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).
Time frame: Week 26
Number of Subjects With Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs
Number of Subjects with Treatment-emergent SAEs, AEs, relatedness to study medication and Withdrawals Due to AEs AEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse events 'Possibly related' refers to the Investigators' causality assessment
Time frame: From day 1 throughout the study period (day 182/week 26)
Number of Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs
Number of Treatment-emergent SAEs, AEs, relatedness to study medication and Withdrawals Due to AEs AEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse events 'Possibly related' refers to the Investigators' causality assessment
Time frame: From day 1 throughout the study period (day 182/week 26)
| Milestone | Placebo Group | Avacopan Group |
|---|---|---|
| Started | 29 | 28 |
| Completed | 25 | 25 |
| Not completed | 4 | 3 |
Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement. C3G=C3 glomerulopathy
| score on a scale | Placebo Group | Avacopan Group |
|---|---|---|
| Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Subjects With Elevated C5b-9 | -0.9 (-2.2 to 0.4) | -1.0 (-2.3 to 0.4) |
Percent change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement. C3G=C3 glomerulopathy \* Multiple Imputation: Missing Week 26 values are imputed using the regression method to create 100 complete datasets.
| Percentage change | Placebo Group | Avacopan Group |
|---|---|---|
| Percent Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Combined C5b-9 Strata | 26.20 ± 47.302 | -5.77 ± 5.904 |
Proportion of subjects who have a histologic response defined as a decrease (improvement) in the biopsy-based C3G Histologic Index for activity of at least 35% from baseline to 26 weeks - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement. C3G=C3 glomerulopathy
| Participants | Placebo Group | Avacopan Group |
|---|---|---|
| Responder | 4 | 2 |
| Non-Responder | 16 | 16 |
Proportion of subjects who have a histologic response defined as a decrease (improvement) in the biopsy-based C3G Histologic Index for activity of at least 35% from baseline to 26 weeks - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement. C3G=C3 glomerulopathy
| Participants | Placebo Group | Avacopan Group |
|---|---|---|
| Responder | 7 | 4 |
| Non-Responder | 18 | 21 |
Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease chronicity over the placebo-controlled treatment period - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. C3G Histological Index for Disease Chronicity Scores can range from 0 to 10. A decrease indicates improvement. C3G=C3 glomerulopathy
| score on a scale | Placebo Group | Avacopan Group |
|---|---|---|
| Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Subjects With Elevated C5b-9 | 1.5 (0.9 to 2.2) | 1.1 (0.3 to 1.8) |
Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease chronicity over the placebo-controlled treatment period - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. C3G Histological Index for Disease Chronicity Scores can range from 0 to 10. A decrease indicates improvement. C3G=C3 glomerulopathy
| score on a scale | Placebo Group | Avacopan Group |
|---|---|---|
| Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Combined C5b-9 Strata | 1.6 (1.1 to 2.2) | 0.8 (0.2 to 1.4) |
The percent change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population.
| Percentage change | Placebo Group | Avacopan Group |
|---|---|---|
| Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9 | -4.73 (-12.29 to 2.83) | 6.11 (-1.86 to 14.08) |
The percent change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population.
| Percentage change | Placebo Group | Avacopan Group |
|---|---|---|
| Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata | -5.88 (-12.32 to 0.56) | 4.79 (-1.66 to 11.23) |
The change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population.
| mL/min/1.73m^2 | Placebo Group | Avacopan Group |
|---|---|---|
| Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9 | -3.57 (-8.43 to 1.29) | 0.44 (-4.69 to 5.56) |
The change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population.
| mL/min/1.73m^2 | Placebo Group | Avacopan Group |
|---|---|---|
| Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata | -3.35 (-7.56 to 0.85) | 0.47 (-3.75 to 4.68) |
Percent change from baseline Over 26 Weeks in UPCR in patients with Abnormal UPCR at Baseline (\>= 0.15 g/g) - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. LSM=Least Squares Mean; UPCR = Urine Protein : Creatinine Ratio
| Percentage change | Placebo Group | Avacopan Group |
|---|---|---|
| Percent Change From Baseline Over 26 Weeks in UPCR in Patients With Abnormal UPCR at Baseline - Subjects With Elevated C5b-9 | -14 (-34 to 12) | -16 (-36 to 12) |
Percent change from baseline Over 26 Weeks in UPCR in patients with Abnormal UPCR at Baseline (\>= 0.15 g/g) - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. LSM=Least Squares Mean; UPCR = Urine Protein : Creatinine Ratio
| Percentage change | Placebo Group | Avacopan Group |
|---|---|---|
| Percent Change From Baseline Over 26 Weeks in UPCR in Patients With Abnormal UPCR at Baseline - Combined C5b-9 Strata | -14 (-33 to 10) | -26 (-42 to -6) |
Percent change from baseline over 26 weeks in urinary MCP-1: creatinine ratio - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. LSM=Least Squares Mean; MCP-1=Monocyte Chemoattractant Protein-1
| Percentage change | Placebo Group | Avacopan Group |
|---|---|---|
| Percent Change From Baseline Over 26 Weeks in Urinary MCP-1 - Subjects With Elevated C5b-9 | 1 (-18 to 25) | -23 (-39 to -4) |
Percent change from baseline over 26 weeks in urinary MCP-1: creatinine ratio - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. LSM=Least Squares Mean; MCP-1=Monocyte Chemoattractant Protein-1
| Percentage change | Placebo Group | Avacopan Group |
|---|---|---|
| Percent Change From Baseline Over 26 Weeks in Urinary MCP-1 - Combined C5b-9 Strata | 1 (-17 to 23) | -12 (-28 to 7) |
Change from baseline over 26 weeks in EQ-5D-5L Health Scale VAS and Index Score - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).
| score on a scale | Placebo Group | Avacopan Group |
|---|---|---|
| EQ-5D-5L VAS Score | -3.5 (-7.8 to 0.8) | -1.9 (-6.4 to 2.7) |
| EQ-5D-5L Index Score | 0.0220 (-0.0206 to 0.0647) | -0.0202 (-0.0653 to 0.0249) |
Change from baseline over 26 weeks in EQ-5D-5L Health Scale VAS and Index Score - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).
| score on a scale | Placebo Group | Avacopan Group |
|---|---|---|
| EQ-5D-5L VAS Score | 0.1 (-3.9 to 4.2) | -1.9 (-6.0 to 2.2) |
| EQ-5D-5L Index Score | 0.0060 (-0.0334 to 0.0454) | -0.0138 (-0.0533 to 0.0256) |
Change from baseline over 26 weeks in SF-36 v2 - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. SF-36v2: Medical Outcomes Survey Short Form-36 version 2. SF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).
| score on a scale | Placebo Group | Avacopan Group |
|---|---|---|
| SF-36v2: Physical Functioning | 2.8518 (-3.2409 to 8.9446) | 3.2197 (-3.3108 to 9.7502) |
| SF-36v2: Role-Physical | -4.2592 (-11.5984 to 3.0801) | 3.5162 (-4.2634 to 11.2958) |
| SF-36v2: Bodily Pain | 3.6 (-4.2 to 11.4) | -3.5 (-12.0 to 4.9) |
| SF-36v2: General Health Perceptions | -0.9 (-7.0 to 5.2) | 1.6 (-4.8 to 8.0) |
| SF-36v2: Vitality | -2.472 (-8.906 to 3.963) | 3.898 (-2.978 to 10.774) |
| SF-36v2: Social Functioning | 4.58 (-2.30 to 11.47) | 0.34 (-7.20 to 7.88) |
| SF-36v2: Role-Emotional | 0.6859 (-6.8507 to 8.2225) | 3.2461 (-4.6899 to 11.1821) |
| SF-36v2: Mental Health | 2.423 (-3.684 to 8.530) | 2.730 (-3.791 to 9.251) |
| SF-36v2: Physical Component | -0.3257 (-2.6090 to 1.9576) | 0.0762 (-2.4423 to 2.5947) |
| SF-36v2: Mental Component | 0.7556 (-2.3560 to 3.8672) | 0.7608 (-2.6341 to 4.1558) |
Change from baseline over 26 weeks in SF-36 v2 - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. SF-36v2: Medical Outcomes Survey Short Form-36 version 2. SF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).
| score on a scale | Placebo Group | Avacopan Group |
|---|---|---|
| SF-36v2: Physical Functioning | 2.9619 (-2.7150 to 8.6389) | 4.6532 (-1.1123 to 10.4187) |
| SF-36v2: Role-Physical | -2.4712 (-9.6179 to 4.6755) | 1.2077 (-5.9734 to 8.3887) |
| SF-36v2: Bodily Pain | 1.5 (-5.7 to 8.7) | -2.0 (-9.3 to 5.4) |
| SF-36v2: General Health Perceptions | -1.0 (-6.6 to 4.6) | 0.7 (-4.9 to 6.2) |
| SF-36v2: Vitality | -0.468 (-6.283 to 5.348) | 4.085 (-1.782 to 9.952) |
| SF-36v2: Social Functioning | 4.66 (-1.41 to 10.73) | 1.55 (-4.66 to 7.76) |
| SF-36v2: Role-Emotional | 4.3024 (-3.3147 to 11.9195) | 7.8375 (0.2129 to 15.4620) |
| SF-36v2: Mental Health | 1.503 (-3.911 to 6.917) | 3.914 (-1.543 to 9.370) |
| SF-36v2: Physical Component | -0.3578 (-2.5452 to 1.8296) | -0.5096 (-2.7680 to 1.7489) |
| SF-36v2: Mental Component | 1.3591 (-1.7970 to 4.5153) | 2.3874 (-0.8529 to 5.6277) |
Number of Subjects with Treatment-emergent SAEs, AEs, relatedness to study medication and Withdrawals Due to AEs AEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse events 'Possibly related' refers to the Investigators' causality assessment
| participants | Placebo Group | Avacopan Group |
|---|---|---|
| Number of subjects with at least one TEAE | 24 | 25 |
| Number of subjects with SAEs | 3 | 3 |
| Number of subjects with TEAEs possibly related to Study Medication | 11 | 10 |
| Number of subjects with TEAEs leading to discontinuation | 1 | 1 |
Number of Treatment-emergent SAEs, AEs, relatedness to study medication and Withdrawals Due to AEs AEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse events 'Possibly related' refers to the Investigators' causality assessment
| Adverse events | Placebo Group | Avacopan Group |
|---|---|---|
| Number of TEAEs | 107 | 149 |
| Number of SAEs | 4 | 6 |
| Number of TEAEs possibly related to Study Medication | 24 | 38 |
| Number of TEAEs leading to discontinuation | 2 | 2 |
Collected over From day 1 throughout the study period (day 182/week 26). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Group | 0/29 (0%) | 3/29 (10.3%) | 24/29 (82.8%) |
| Avacopan Group | 0/28 (0%) | 3/28 (10.7%) | 25/28 (89.3%) |
| Event | Placebo Group | Avacopan Group |
|---|---|---|
| Gastroenteritis salmonellaInfections and infestations | 0/29 | 1/28 |
| Neutropenic sepsisInfections and infestations | 0/29 | 1/28 |
| PneumoniaInfections and infestations | 1/29 | 1/28 |
| Neutrophil count decreasedInvestigations | 0/29 | 1/28 |
| Sjogren's syndromeMusculoskeletal and connective tissue disorders | 0/29 | 1/28 |
| Acute kidney injuryRenal and urinary disorders | 0/29 | 1/28 |
| Bacterial parotitisInfections and infestations | 1/29 | 0/28 |
| BronchitisInfections and infestations | 1/29 | 0/28 |
| Alcohol withdrawal syndromePsychiatric disorders | 1/29 | 0/28 |
| Event | Placebo Group | Avacopan Group |
|---|---|---|
| Oedema peripheralGeneral disorders | 1/29 | 5/28 |
| HeadacheNervous system disorders | 2/29 | 5/28 |
| VomitingGastrointestinal disorders | 1/29 | 4/28 |
| FatigueGeneral disorders | 0/29 | 3/28 |
| Blood creatine phosphokinase increasedInvestigations | 1/29 | 3/28 |
| Blood creatinine increasedInvestigations | 0/29 | 3/28 |
| Weight decreasedInvestigations | 0/29 | 3/28 |
| AnaemiaBlood and lymphatic system disorders | 3/29 | 3/28 |
| LymphopeniaBlood and lymphatic system disorders | 0/29 | 3/28 |
| Decreased appetiteMetabolism and nutrition disorders | 0/29 | 3/28 |
| Age, Continuous(years) | Placebo Group | Avacopan Group | Total |
|---|---|---|---|
| Mean | 37.2 ± 17.53 | 32.2 ± 15.03 | 34.7 ± 16.39 |
| Age, Customized(Participants) | Placebo Group | Avacopan Group | Total |
|---|---|---|---|
| 12-17 years | 2 | 0 | 2 |
| 18-50 years | 20 | 23 | 43 |
| 51-65 years | 4 | 4 | 8 |
| >65 years | 3 | 1 | 4 |
| Sex: Female, Male(Participants) | Placebo Group | Avacopan Group | Total |
|---|---|---|---|
| Female | 13 | 9 | 22 |
| Male | 16 | 19 | 35 |
| Ethnicity (NIH/OMB)(Participants) | Placebo Group | Avacopan Group | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 2 | 6 |
| Not Hispanic or Latino | 25 | 26 | 51 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo Group | Avacopan Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 2 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 25 | 24 | 49 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | Placebo Group | Avacopan Group | Total |
|---|---|---|---|
| Canada | 2 | 3 | 5 |
| Netherlands | 5 | 1 | 6 |
| Belgium | 1 | 2 | 3 |
| United States | 10 | 11 | 21 |
| Ireland | 3 | 3 | 6 |
| Denmark | 1 | 1 | 2 |
| Italy | 1 | 0 | 1 |
| United Kingdom | 2 | 2 | 4 |
| Germany | 2 | 1 | 3 |
| Spain | 2 | 4 | 6 |
| Geographic Region(Participants) | Placebo Group | Avacopan Group | Total |
|---|---|---|---|
| North America | 12 | 14 | 26 |
| Rest of World | 17 | 14 | 31 |
| Age at Diagnosis of C3G(years) | Placebo Group | Avacopan Group | Total |
|---|---|---|---|
| Mean | 33.3 ± 17.95 | 28.2 ± 17.08 | 30.8 ± 17.56 |
16 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Data sharing details ↗ · www.amgen.com
Ran from Sep 2017 to primary completion in Mar 2021, 41 months.
Results were first posted in Oct 2022, 1 year 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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