A Phase 2 interventional study of CCX140-B in Focal Segmental Glomerulosclerosis, sponsored by Amgen. Terminated at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by Amgen · Phase 2, Interventional, and Treatment
Among 68 studies in Glomerulosclerosis, Focal Segmental with a site in United States — 17 open to participants now, 20 under way, 2 of them phase 3. Glomerulosclerosis, Focal Segmental · United States.
Among the 68 studies in Glomerulosclerosis, Focal Segmental with a site in United States, this one is the 50th largest by enrollment of the 56 interventional ones, is one of 5 that started in 2018, is one of 29 in phase 2, and was the 37th registered.
105 studies on the registry are indexed under Glomerulosclerosis, Focal Segmental; 33 are open to participants now.
This study's enrollment of 5 is below the median of 30 across 73 interventional studies indexed under Glomerulosclerosis, Focal Segmental.
Browse Glomerulosclerosis, Focal Segmental studies →17 of the 68 studies in Glomerulosclerosis, Focal Segmental with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 30 Glomerulosclerosis, Focal Segmental studies recruiting now, 11 (37%) set no upper age limit and 12 (40%) stop at 75 or younger; 22 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →68 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 5 started in 2018.
Median enrollment 30 across the 56 interventional studies, 201 across the 12 observational. Of the 45 that completed or were terminated, 23 (51%) have results posted.
33 of 68 have an industry lead sponsor. The 10 most frequent:
Amgen is the lead sponsor of 1,047 studies on the registry; 52 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 166 (67%) have results posted.
Amgen has 2 studies filed under Glomerulosclerosis, Focal Segmental — fewer than ten, so there is no comparison to draw.
10 of the studies in Glomerulosclerosis, Focal Segmental with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01094327University of MiamiProteinuria in Pre and Post Transplant | 2026-11-30 |
| NCT06500702SanofiA Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease | 2026-12-23 |
| NCT07219121Travere Therapeutics, Inc.Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis | 2027-03 |
| NCT05583942Northwell HealthA Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS) | 2027-03-01 |
| NCT05588063Northwell HealthtaVNS for FRNS in Children | 2027-03-01 |
Among the 68 studies in Glomerulosclerosis, Focal Segmental with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
An Open Label, Intra-Subject Dose Escalation Study of CCX140 B in Subjects with Primary FSGS and Nephrotic Syndrome
An Open Label, Intra-Subject Dose Escalation Study of CCX140 B in Subjects with Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome. The aim of this study is to explore the effect of CCX140-B, a selective antagonist of C-C chemokine receptor type 2, on proteinuria in subjects with FSGS.
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.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All enrolled subjects will initially be treated with the active study medication CCX140-B at a dose of 5 mg twice daily. Dose will increase in a step-wise fashion up to 15 mg twice daily.
Drug: CCX140-B
Orally administered tablet
The Number of Subjects With a Reduction in Urine Protein to Creatinine Ratio (UPCR) of at Least 20%
Number of subjects with a reduction in Urine Protein to Creatinine Ratio (UPCR) of at least 20% , i.e., ≥20%, by Week 12.
Time frame: Baseline to week 12
Achievement of Partial or Complete Remission of UPCR Through Week 12 and Through the End of Treatment
Partial and complete remission were defined as follows: Partial remission (included all of the following): * Reduction from baseline by ≥50% in urine protein:creatinine ratio (UPCR) * Reduction in UPCR to a level that was \<3.5 g/g * Subject could not have been a treatment failure Complete remission (included all of the following): * Reduction in UPCR to \<0.3 g/g * Serum albumin within normal range * For subjects with abnormal serum creatinine levels at baseline, return to normal levels * For subjects with normal serum creatinine levels at baseline, final value within 20% of baseline levels * Subject could not have been a treatment failure
Time frame: Baseline to week 12
Proportion of Subjects With Achievement of Complete Remission During the Treatment Period
Complete remission is defined as reduction in urine protein:creatinine ratio (UPCR) to \<0.3 g/g, normal serum albumin, and normal serum creatinine levels or within 20% of baseline levels.
Time frame: Baseline to week 52
Time Taken of Subjects to Achieve Complete Remission During the Treatment Period
Complete remission is defined as reduction in urine protein:creatinine ratio (UPCR) to \<0.3 g/g, normal serum albumin, and normal serum creatinine levels or within 20% of baseline levels.
Time frame: Baseline to week 52
Change From Baseline in Urine Protein:Creatinine Ratio (UPCR) Over Time
Mean change from baseline in urinary protein:creatinine ratio (UPCR) over time.
Time frame: Baseline to week 12 and week 52
Assessment of Time to and Proportion of Subjects With Achievement of Partial Remission During the Treatment Period
Partial remission is defined as reduction from baseline by ≥50% in UPCR, reduction in UPCR to a level that was \<3.5 g/g.
Time frame: Baseline to week 52
Time to Rescue Therapy
Based on Investigator or physician initiation of glucocorticoids or new immunosuppressive agents or new major treatment modalities (e.g. plasmapheresis, dialysis)
Time frame: Baseline to week 52
Mean Change From Baseline for eGFR Using the CKD-EPI Cystatin C Equation Over Time
eGFR-Estimated Glomerular Filtration Rate;CKD-EPI=Chronic Kidney Disease Epidemiology Collaboration
Time frame: Baseline to Week 12 and Week 52
Mean Change From Baseline for the eGFR CKD-EPI Creatinine Equation Over Time
CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate
Time frame: Baseline to Week 12 and Week 52
Mean Change From Baseline for eGFR CKD-EPI Creatinine-Cystatin C Equation Over Time
CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate;
Time frame: Baseline to Week 12 and Week 52
Mean Change From Baseline for the MDRD Creatinine Equation Over Time
MDRD = Modification of Diet in Renal Disease. The mean eGFR (using the MDRD Creatinine equation) change from baseline to Week 12 and Week 52
Time frame: Baseline to Week 12 and Week 52
Effect of CCX140-B Treatment on Quality of Life Endpoint SF-36V2
Summary of the Effect of CCX140-B Treatment on Quality of Life Endpoints SF-36V2 for the overall trial 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: Baseline to Week 52
Effect of CCX140-B Treatment on Quality of Life Endpoint EQ-5D-5L for the Overall Trial
Summary of the Effect of CCX140-B Treatment on Quality of Life Endpoint EQ-5D-5L for the overall trial EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of : the EQ-5D descriptive system. 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 scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.
Time frame: Baseline to Week 12 and Week 52
Changes to Laboratory Parameters Related to Renal Function Including Serum Albumin, Creatinine, Cystatin C, Urinary Albumin:Creatinine Ratio, Total 24-hour Protein Excretion During the Trial
Changes to laboratory parameters related to renal function including serum albumin, creatinine, cystatin C, urinary albumin:creatinine ratio, total 24-hour protein excretion during the trial
Time frame: Baseline to Day 57
| Milestone | CCX140-B |
|---|---|
| Started | 5 |
| Completed | 2 |
| Not completed | 3 |
Number of subjects with a reduction in Urine Protein to Creatinine Ratio (UPCR) of at least 20% , i.e., ≥20%, by Week 12.
| Participants | CCX140-B |
|---|---|
| The Number of Subjects With a Reduction in Urine Protein to Creatinine Ratio (UPCR) of at Least 20% | 2 |
Partial and complete remission were defined as follows: Partial remission (included all of the following): * Reduction from baseline by ≥50% in urine protein:creatinine ratio (UPCR) * Reduction in UPCR to a level that was \<3.5 g/g * Subject could not have been a treatment failure Complete remission (included all of the following): * Reduction in UPCR to \<0.3 g/g * Serum albumin within normal range * For subjects with abnormal serum creatinine levels at baseline, return to normal levels * For subjects with normal serum creatinine levels at baseline, final value within 20% of baseline levels * Subject could not have been a treatment failure
| Participants | CCX140-B |
|---|---|
| No Complete or Partial remission at week 12/ end of treatment | 4 |
| Partial remission at Week 12 | 1 |
Complete remission is defined as reduction in urine protein:creatinine ratio (UPCR) to \<0.3 g/g, normal serum albumin, and normal serum creatinine levels or within 20% of baseline levels.
| Participants | CCX140-B |
|---|---|
| Achieved complete remission | 0 |
| Did not achieve complete remission | 5 |
Complete remission is defined as reduction in urine protein:creatinine ratio (UPCR) to \<0.3 g/g, normal serum albumin, and normal serum creatinine levels or within 20% of baseline levels.
| days | CCX140-B |
|---|---|
| Time Taken of Subjects to Achieve Complete Remission During the Treatment Period | NA |
Mean change from baseline in urinary protein:creatinine ratio (UPCR) over time.
| g protein/g creatinine | CCX140-B |
|---|---|
| Week 12 | -1.3100 ± 3.76247 |
| Week 52 | -0.4985 ± 3.37926 |
Partial remission is defined as reduction from baseline by ≥50% in UPCR, reduction in UPCR to a level that was \<3.5 g/g.
| Participants | CCX140-B |
|---|---|
| Partial remission at Week 12 | 1 |
| Did not achieve partial remission | 4 |
Based on Investigator or physician initiation of glucocorticoids or new immunosuppressive agents or new major treatment modalities (e.g. plasmapheresis, dialysis)
No measurements were reported for this outcome.
eGFR-Estimated Glomerular Filtration Rate;CKD-EPI=Chronic Kidney Disease Epidemiology Collaboration
| mL/min/1.73m² | CCX140-B |
|---|---|
| Week 12 | 7.50 (-11.0 to 37.0) |
| Week 52 | -2.00 (-2.0 to -2.0) |
CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate
| ml/min/1.73 m² | CCX140-B |
|---|---|
| Week 12 | -14.50 (-27.0 to -6.0) |
| Week 52 | -15.0 (-15.0 to -15.0) |
CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate;
| ml/min/1.73 m² | CCX140-B |
|---|---|
| Week 12 | -2.25 (-18.0 to 13.0) |
| Week 52 | -8.0 (-8.0 to -8.0) |
MDRD = Modification of Diet in Renal Disease. The mean eGFR (using the MDRD Creatinine equation) change from baseline to Week 12 and Week 52
| ml/min/1.73 m² | CCX140-B |
|---|---|
| Week 12 | -12.75 (-24.0 to -5.0) |
| Week 52 | -13.00 (-13.00 to -13.00) |
Summary of the Effect of CCX140-B Treatment on Quality of Life Endpoints SF-36V2 for the overall trial 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).
No measurements were reported for this outcome.
Summary of the Effect of CCX140-B Treatment on Quality of Life Endpoint EQ-5D-5L for the overall trial EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of : the EQ-5D descriptive system. 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 scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.
| score on a scale | CCX140-B |
|---|---|
| Week 12 | 66.3 ± 31.98 |
| Week 52 | 85 ± 0 |
Changes to laboratory parameters related to renal function including serum albumin, creatinine, cystatin C, urinary albumin:creatinine ratio, total 24-hour protein excretion during the trial
No measurements were reported for this outcome.
Collected over 52 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CCX140-B | 0/5 (0%) | 0/5 (0%) | 4/5 (80%) |
| Event | CCX140-B |
|---|---|
| Amylase increasedInvestigations | 1/5 |
| Blood creatine phosphokinase increasedInvestigations | 1/5 |
| Blood potassium increasedInvestigations | 1/5 |
| Lipase increasedInvestigations | 1/5 |
| FatigueGeneral disorders | 1/5 |
| Oedema peripheralGeneral disorders | 1/5 |
| PyrexiaGeneral disorders | 1/5 |
| Upper respiratory tract infectionInfections and infestations | 1/5 |
| NasopharyngitisInfections and infestations | 1/5 |
| Pulpitis dentalInfections and infestations | 1/5 |
| Age, Continuous(years) | CCX140-B |
|---|---|
| Mean | 37.6 ± 18.65 |
| Sex: Female, Male(Participants) | CCX140-B |
|---|---|
| Female | 1 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | CCX140-B |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | CCX140-B |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | CCX140-B |
|---|---|
| United States | 4 |
| Poland | 1 |
| Age at diagnosis of FSGS (years)(years) | CCX140-B |
|---|---|
| Mean | 35.2 ± 19.18 |
| Duration of FSGS (months)(months) | CCX140-B |
|---|---|
| Mean | 29.4 ± 16.32 |
| Baseline UPCR - morning void(g protein/ g creatinine) | CCX140-B |
|---|---|
| Mean | 5.71 ± 1.563 |
11 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2018 to primary completion in Jun 2020, 20 months.
Results were first posted in Feb 2024, 3 years 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: CCX140-B
Glomerulosclerosis, Focal Segmental →