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
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.
Exclusion Criteria:
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.
Documents are hosted by the registry — open the source record to download them.
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