A Phase 2 interventional study of APL-2 in IgA Nephropathy, Lupus Nephritis and Membranous Nephropathy, sponsored by Apellis Pharmaceuticals, Inc.. Completed at 17 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Apellis Pharmaceuticals, Inc. (part of Biogen) · Phase 2, Interventional, and Treatment
Among 73 studies in Glomerulonephritis, IGA with a site in United States — 25 open to participants now, 37 under way, 16 of them phase 3. Glomerulonephritis, IGA · United States.
Among the 73 studies in Glomerulonephritis, IGA with a site in United States, this one is the 54th largest by enrollment of the 67 interventional ones that give a count, is one of 5 that started in 2018, is one of 30 in phase 2, and was the 18th registered.
276 studies on the registry are indexed under Glomerulonephritis, IGA; 108 are open to participants now.
Browse Glomerulonephritis, IGA studies →25 of the 73 studies in Glomerulonephritis, IGA with a site in United States are open now. Recruiting first, the newest first:
Jade Biosciences, Inc. · Sites in United States
Ages 18+
argenx · Sites in United States, Japan
Ages 18+
Pediatric Nephrology Research Consortium · Sites in United States
Ages up to 18
Novartis Pharmaceuticals · Sites in United States, China, Colombia and 5 more countries
Ages 2–18
Akebia Therapeutics · Sites in United States, Brazil
Ages 16+
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 68 Glomerulonephritis, IGA studies recruiting now, 39 (57%) set no upper age limit and 24 (35%) stop at 75 or younger; 21 take children under 18; 5 take healthy volunteers.
This study: 18 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.
73 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 33 · Phase 3 22 · Phase 4 7
First in 1997; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 21 is below the median of 62 across 221 interventional studies indexed under Glomerulonephritis, IGA.
Median enrollment 67 across the 67 interventional studies, 744 across the 6 observational. Of the 34 that completed or were terminated, 25 (74%) have results posted.
This tab as a report to print or save as PDF → With an account.
57 of 73 have an industry lead sponsor. The 10 most frequent:
This study is registered under Apellis Pharmaceuticals, Inc., one of the names counted as Biogen. Under that name alone:
Apellis Pharmaceuticals, Inc. is the lead sponsor of 28 studies on the registry; 3 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
Biogen has 5 studies filed under Glomerulonephritis, IGA — fewer than ten, so there is no comparison to draw.
8 of the studies in Glomerulonephritis, IGA with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06935357Phase 3BiogenA Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN) | 2027-05-31 |
| NCT05852938Phase 3Novartis PharmaceuticalsA Study of Zigakibart in Adults With IgA Nephropathy | 2027-08-10 |
| NCT06712407Calliditas Therapeutics ABEfficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy | 2027-03 |
| NCT06466135Walden BiosciencesStudy of WAL0921 in Patients With Glomerular Kidney Diseases | 2027-03 |
| NCT05003986Travere Therapeutics, Inc.Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases | 2027-03-12 |
Add all 8 to your calendar (.ics) → With an account.
Among the 73 studies in Glomerulonephritis, IGA with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a Phase II trial assessing the safety and preliminary efficacy of daily APL-2 subcutaneous infusion administered for 16 weeks with a 6 month safety follow up, in patients with glomerulopathies
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.
Patients must have a diagnosis of IgAN, LN, Primary MN, or C3G confirmed by renal and required measurements performed prior to study participation
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.
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 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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Open Label, Study Drug, APL-2
Drug: APL-2
APL-2 administered as a daily subcutaneous infusion for 48 weeks
Part A: Change From Baseline in Proteinuria at Week 48
Change from baseline in proteinuria was assessed based on urinary protein-to-creatinine ratio (uPCR). Baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug.
Time frame: Baseline (Day 1) and Week 48
Part B: Change From Baseline in Proteinuria at Week 168
Change from baseline in proteinuria was assessed based on uPCR. Baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B.
Time frame: Baseline (Part A, Week 48) and Week 168
Parts A and B: Change From Baseline in Serum Complement 3 (C3) Levels at Week 48 of Part A and Week 168 of Part B
Blood samples were collected to measure serum C3 levels. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B.
Time frame: Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168
Parts A and B: Change From Baseline in Alternative Pathway Hemolytic Assay (AH50) Activity at Week 48 of Part A and Week 168 of Part B
Blood samples were collected to measure AH50 activity. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B.
Time frame: Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168
Parts A and B: Change From Baseline in C3a Concentrations at Week 48 of Part A and Week 168 of Part B
Blood samples were collected to measure C3a concentrations. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B.
Time frame: Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168
Parts A and B: Change From Baseline in Serum Albumin Levels at Week 48 of Part A and Week 168 of Part B
Blood samples were collected to measure serum albumin levels. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B.
Time frame: Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168
Parts A and B: Number of Subjects With Complete Clinical Remission at Week 48 of Part A and Week 168 of Part B
The complete clinical remission was defined as normalization of proteinuria as defined by \<200 mg/g uPCR.
Time frame: Part A: Week 48; Part B: Week 168
Parts A and B: Number of Subjects With Stabilization or Improvement in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 48 of Part A and Week 168 of Part B
The eGFR stabilization or improvement was defined as an eGFR value that was no more than a 25% decrease relative to baseline. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B.
Time frame: Part A: Baseline (Day 1) and Week 48; Part B: Baseline (Part A, Week 48) and Week 168
This prospective Phase 2, open-label study was conducted in subjects clinically diagnosed with immunoglobulin A nephropathy (IgAN), lupus nephritis (LN), primary membranous nephropathy (PMN), or C3 glomerulopathy (C3G) between 26 February 2018 and 25 August 2023.
| Milestone | IgAN Subjects | LN Subjects | PMN Subjects | C3G Subjects |
|---|---|---|---|---|
| Started | 6 | 2 | 5 | 8 |
| Completed | 4 | 1 | 1 | 7 |
| Not completed | 2 | 1 | 4 | 1 |
| Withdrew: Physician decision | 0 | 0 | 2 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 | 2 | 1 |
| Withdrew: Other | 0 | 1 | 0 | 0 |
| Milestone | IgAN Subjects | LN Subjects | PMN Subjects | C3G Subjects |
|---|---|---|---|---|
| Started | 4 | 1 | 0 | 7 |
| Completed | 2 | 0 | 0 | 5 |
| Not completed | 2 | 1 | 0 | 2 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 1 |
| Withdrew: Non-compliance with study drug | 0 | 0 | 0 | 1 |
| Withdrew: Physician decision | 0 | 1 | 0 | 0 |
Change from baseline in proteinuria was assessed based on urinary protein-to-creatinine ratio (uPCR). Baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug.
| ratio | Part A: IgAN Subjects | Part A: LN Subjects | Part A: PMN Subjects | Part A: C3G Subjects |
|---|---|---|---|---|
| Part A: Change From Baseline in Proteinuria at Week 48 | -0.1364 (-1.0641 to 0.7913) | 0.3560 (NA to NA) | 0.3430 (NA to NA) | -2.0347 (-3.9033 to -0.1662) |
Blood samples were collected to measure serum C3 levels. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B.
| milligram per deciliter | Part A: IgAN Subjects | Part A: LN Subjects | Part A: PMN Subjects | Part A: C3G Subjects | Part B: IgAN Subjects | Part B: LN Subjects | Part B: C3G Subjects |
|---|---|---|---|---|---|---|---|
| Parts A and B: Change From Baseline in Serum Complement 3 (C3) Levels at Week 48 of Part A and Week 168 of Part B | 153.17 (27.94 to 278.39) | — | 324.00 (NA to NA) | 194.43 (109.45 to 279.41) | -74.00 (-506.01 to 358.01) | — | -48.50 (-214.73 to 117.73) |
Blood samples were collected to measure AH50 activity. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B.
| units per milliliter | Part A: IgAN Subjects | Part A: LN Subjects | Part A: PMN Subjects | Part A: C3G Subjects | Part B: IgAN Subjects | Part B: LN Subjects | Part B: C3G Subjects |
|---|---|---|---|---|---|---|---|
| Parts A and B: Change From Baseline in Alternative Pathway Hemolytic Assay (AH50) Activity at Week 48 of Part A and Week 168 of Part B | -17.3 (-71.0 to 36.3) | — | -48.0 (NA to NA) | 4.0 (-59.7 to 67.7) | 9.0 (-16.4 to 34.4) | — | 27.0 (-89.7 to 143.7) |
Blood samples were collected to measure C3a concentrations. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B.
| microgram per liter | Part A: IgAN Subjects | Part A: LN Subjects | Part A: PMN Subjects | Part A: C3G Subjects | Part B: IgAN Subjects | Part B: LN Subjects | Part B: C3G Subjects |
|---|---|---|---|---|---|---|---|
| Parts A and B: Change From Baseline in C3a Concentrations at Week 48 of Part A and Week 168 of Part B | 1283.93 (-1963.09 to 4530.95) | — | 56.30 (NA to NA) | 55.16 (-173.33 to 283.65) | -10.00 (-41.77 to 21.77) | — | -100.65 (-361.20 to 159.90) |
Blood samples were collected to measure serum albumin levels. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B.
| gram per deciliter | Part A: IgAN Subjects | Part A: LN Subjects | Part A: PMN Subjects | Part A: C3G Subjects | Part B: IgAN Subjects | Part B: LN Subjects | Part B: C3G Subjects |
|---|---|---|---|---|---|---|---|
| Parts A and B: Change From Baseline in Serum Albumin Levels at Week 48 of Part A and Week 168 of Part B | -0.17 (-0.81 to 0.48) | — | 0.20 (-6.15 to 6.55) | 0.59 (-0.29 to 1.46) | -0.30 (-6.65 to 6.05) | — | -0.53 (-3.60 to 2.53) |
The complete clinical remission was defined as normalization of proteinuria as defined by \<200 mg/g uPCR.
| Participants | Part A: IgAN Subjects | Part A: LN Subjects | Part A: PMN Subjects | Part A: C3G Subjects | Part B: IgAN Subjects | Part B: LN Subjects | Part B: C3G Subjects |
|---|---|---|---|---|---|---|---|
| <200 | 0 | 0 | 0 | 0 | 0 | — | 1 |
| >=200 | 5 | 1 | 1 | 7 | 2 | — | 3 |
The eGFR stabilization or improvement was defined as an eGFR value that was no more than a 25% decrease relative to baseline. Part A baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Part B baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B.
| Participants | Part A: IgAN Subjects | Part A: LN Subjects | Part A: PMN Subjects | Part A: C3G Subjects | Part B: IgAN Subjects | Part B: LN Subjects | Part B: C3G Subjects |
|---|---|---|---|---|---|---|---|
| Stable GFR: no more than 25% (+/-) change | 3 | 0 | 1 | 5 | 2 | — | 3 |
| Improvement in GFR: >25% increase | 0 | 0 | 0 | 1 | 0 | — | 0 |
| Worsening of GFR: >25% decrease | 3 | 0 | 1 | 1 | 0 | — | 0 |
Change from baseline in proteinuria was assessed based on uPCR. Baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug during Part B.
| ratio | Part B: IgAN Subjects | Part B: LN Subjects | Part B: C3G Subjects |
|---|---|---|---|
| Part B: Change From Baseline in Proteinuria at Week 168 | -0.3385 (-3.8264 to 3.1494) | — | 0.9718 (-4.7933 to 6.7368) |
Collected over TEAE data is reported from first dose of study drug (Day 1) up to 56 days after the last dose of study drug, up to approximately 1745 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A: IgAN Subjects | 0/6 (0%) | 0/6 (0%) | 5/6 (83.3%) |
| Part A: LN Subjects | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| Part A: PMN Subjects | 0/5 (0%) | 4/5 (80%) | 5/5 (100%) |
| Part A: C3G Subjects | 0/8 (0%) | 0/8 (0%) | 8/8 (100%) |
| Part B: IgAN Subjects | 0/4 (0%) | 1/4 (25%) | 4/4 (100%) |
| Part B: LN Subjects | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) |
| Part B: PMN Subjects | — | — | — |
| Part B: C3G Subjects | 0/7 (0%) | 1/7 (14.3%) | 7/7 (100%) |
| Event | Part A: IgAN Subjects | Part A: LN Subjects | Part A: PMN Subjects | Part A: C3G Subjects | Part B: IgAN Subjects | Part B: LN Subjects | Part B: PMN Subjects | Part B: C3G Subjects |
|---|---|---|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 0/6 | 0/2 | 0/5 | 0/8 | 0/4 | 1/1 | — | 0/7 |
| Metabolic acidosisMetabolism and nutrition disorders | 0/6 | 0/2 | 0/5 | 0/8 | 0/4 | 1/1 | — | 0/7 |
| Acute kidney injuryRenal and urinary disorders | 0/6 | 0/2 | 3/5 | 0/8 | 1/4 | 1/1 | — | 1/7 |
| End-stage renal diseaseRenal and urinary disorders | 0/6 | 0/2 | 0/5 | 0/8 | 0/4 | 1/1 | — | 0/7 |
| Pancreatitis acuteGastrointestinal disorders | 0/6 | 0/2 | 0/5 | 0/8 | 1/4 | 0/1 | — | 0/7 |
| CholecystitisHepatobiliary disorders | 0/6 | 0/2 | 1/5 | 0/8 | 0/4 | 0/1 | — | 0/7 |
| Fluid overloadMetabolism and nutrition disorders | 0/6 | 0/2 | 1/5 | 0/8 | 0/4 | 0/1 | — | 0/7 |
| HypercalcaemiaMetabolism and nutrition disorders | 0/6 | 0/2 | 1/5 | 0/8 | 0/4 | 0/1 | — | 0/7 |
| Nephrotic syndromeRenal and urinary disorders | 0/6 | 0/2 | 1/5 | 0/8 | 0/4 | 0/1 | — | 0/7 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 0/6 | 0/2 | 1/5 | 0/8 | 0/4 | 0/1 | — | 0/7 |
| Event | Part A: IgAN Subjects | Part A: LN Subjects | Part A: PMN Subjects | Part A: C3G Subjects | Part B: IgAN Subjects | Part B: LN Subjects | Part B: PMN Subjects | Part B: C3G Subjects |
|---|---|---|---|---|---|---|---|---|
| HypothyroidismEndocrine disorders | 1/6 | 0/2 | 0/5 | 0/8 | 0/4 | 1/1 | — | 0/7 |
| ConstipationGastrointestinal disorders | 0/6 | 0/2 | 0/5 | 0/8 | 0/4 | 1/1 | — | 0/7 |
| Erosive duodenitisGastrointestinal disorders | 0/6 | 0/2 | 0/5 | 0/8 | 0/4 | 1/1 | — | 0/7 |
| Gastritis erosiveGastrointestinal disorders | 0/6 | 0/2 | 0/5 | 0/8 | 0/4 | 1/1 | — | 0/7 |
| NauseaGastrointestinal disorders | 1/6 | 0/2 | 0/5 | 3/8 | 1/4 | 1/1 | — | 2/7 |
| Peripheral swellingGeneral disorders | 0/6 | 0/2 | 0/5 | 0/8 | 0/4 | 1/1 | — | 0/7 |
| Tooth infectionInfections and infestations | 0/6 | 0/2 | 0/5 | 0/8 | 0/4 | 1/1 | — | 0/7 |
| Chronic kidney disease-mineral and bone disorderMusculoskeletal and connective tissue disorders | 0/6 | 0/2 | 0/5 | 0/8 | 0/4 | 1/1 | — | 0/7 |
| HeadacheNervous system disorders | 0/6 | 1/2 | 0/5 | 3/8 | 0/4 | 1/1 | — | 0/7 |
| Renal impairmentRenal and urinary disorders | 0/6 | 0/2 | 0/5 | 0/8 | 0/4 | 1/1 | — | 0/7 |
The Safety population included all subjects who received at least 1 dose of pegcetacoplan.
| Age, Continuous(years) | IgAN Subjects | LN Subjects | PMN Subjects | C3G Subjects | Total |
|---|---|---|---|---|---|
| Mean | 45.2 ± 14.18 | 44.5 ± 10.61 | 62.2 ± 7.43 | 22.5 ± 8.65 | 40.5 ± 18.67 |
| Sex: Female, Male(Participants) | IgAN Subjects | LN Subjects | PMN Subjects | C3G Subjects | Total |
|---|---|---|---|---|---|
| Female | 1 | 0 | 1 | 5 | 7 |
| Male | 5 | 2 | 4 | 3 | 14 |
| Race/Ethnicity, Customized(Participants) | IgAN Subjects | LN Subjects | PMN Subjects | C3G Subjects | Total |
|---|---|---|---|---|---|
| American Indian or Alaskan Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 1 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| White | 4 | 0 | 4 | 6 | 14 |
| Other | 1 | 1 | 0 | 1 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2018 to primary completion in Apr 2020, 25 months.
Results were first posted in Feb 2025, 4 years 9 months after primary completion. A results delay was requested in Aug 2020.
Of 41 phase 2 interventional studies under Glomerulonephritis, IGA, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 50. This study's 25 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pegcetacoplan
Apellis Pharmaceuticals, Inc. →