Trial Outcomes & Findings for A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome (NCT NCT03703908)
NCT ID: NCT03703908
Last Updated: 2025-03-17
Results Overview
Number of subjects with a reduction in Urine Protein to Creatinine Ratio (UPCR) of at least 20% , i.e., ≥20%, by Week 12.
TERMINATED
PHASE2
5 participants
Baseline to week 12
2025-03-17
Participant Flow
Participant milestones
| Measure |
CCX140-B
Drug: CCX140-B, orally administered tablet 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.
|
|---|---|
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Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
2
|
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Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome
Baseline characteristics by cohort
| Measure |
CCX140-B
n=5 Participants
CCX140-B is an orally administered tablet 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.
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|---|---|
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Age, Continuous
|
37.6 years
STANDARD_DEVIATION 18.65 • n=5 Participants
|
|
Sex: Female, Male
Female
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1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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4 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
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1 Participants
n=5 Participants
|
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Age at diagnosis of FSGS (years)
|
35.2 years
STANDARD_DEVIATION 19.18 • n=5 Participants
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Duration of FSGS (months)
|
29.4 months
STANDARD_DEVIATION 16.32 • n=5 Participants
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Baseline UPCR - morning void
|
5.71 g protein/ g creatinine
STANDARD_DEVIATION 1.563 • n=5 Participants
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Baseline UPCR - 24-hour
|
4.80 g protein/ g creatinine
STANDARD_DEVIATION 1.376 • n=5 Participants
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Baseline UACR - morning void
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4.12 g protein/ g creatinine
STANDARD_DEVIATION 1.394 • n=5 Participants
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Baseline UACR - 24-hour
|
3.24 g protein/ g creatinine
STANDARD_DEVIATION 1.316 • n=5 Participants
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Concomitant use of glucocorticoids and/or immunosuppressive medications
Yes
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4 Participants
n=5 Participants
|
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Concomitant use of glucocorticoids and/or immunosuppressive medications
No
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1 Participants
n=5 Participants
|
|
Concomitant use of ACE inhibitor or ARB
Yes
|
5 Participants
n=5 Participants
|
|
Concomitant use of ACE inhibitor or ARB
No
|
0 Participants
n=5 Participants
|
|
All calcineurin inhibitors combined
Yes
|
2 Participants
n=5 Participants
|
|
All calcineurin inhibitors combined
No
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3 Participants
n=5 Participants
|
|
Concomitant use of rituximab or other anti-CD20
Yes
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0 Participants
n=5 Participants
|
|
Concomitant use of rituximab or other anti-CD20
No
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5 Participants
n=5 Participants
|
|
Baseline eGFR (CKD-EPI Creatinine-Cystatin C)
|
50.60 mL/min/1.73m²
STANDARD_DEVIATION 23.923 • n=5 Participants
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Baseline eGFR (MDRD Creatinine)
|
54.40 mL/min/1.73m²
STANDARD_DEVIATION 26.245 • n=5 Participants
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Podocyte effacement
<30%
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1 Participants
n=5 Participants
|
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Podocyte effacement
≥30%
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4 Participants
n=5 Participants
|
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Glomeruli showing segmental lesions
≤1
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1 Participants
n=5 Participants
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Glomeruli showing segmental lesions
>1
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4 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline to week 12Number of subjects with a reduction in Urine Protein to Creatinine Ratio (UPCR) of at least 20% , i.e., ≥20%, by Week 12.
Outcome measures
| Measure |
CCX140-B
n=5 Participants
CCX140-B is an orally administered tablet 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.
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|---|---|
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The Number of Subjects With a Reduction in Urine Protein to Creatinine Ratio (UPCR) of at Least 20%
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2 Participants
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SECONDARY outcome
Timeframe: Baseline to week 12Partial 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
Outcome measures
| Measure |
CCX140-B
n=5 Participants
CCX140-B is an orally administered tablet 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.
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|---|---|
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Achievement of Partial or Complete Remission of UPCR Through Week 12 and Through the End of Treatment
No Complete or Partial remission at week 12/ end of treatment
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4 Participants
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Achievement of Partial or Complete Remission of UPCR Through Week 12 and Through the End of Treatment
Partial remission at Week 12
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1 Participants
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SECONDARY outcome
Timeframe: Baseline to week 52Complete 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.
Outcome measures
| Measure |
CCX140-B
n=5 Participants
CCX140-B is an orally administered tablet 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.
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|---|---|
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Proportion of Subjects With Achievement of Complete Remission During the Treatment Period
Achieved complete remission
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0 Participants
|
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Proportion of Subjects With Achievement of Complete Remission During the Treatment Period
Did not achieve complete remission
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5 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 52Complete 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.
Outcome measures
| Measure |
CCX140-B
n=5 Participants
CCX140-B is an orally administered tablet 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.
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|---|---|
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Time Taken of Subjects to Achieve Complete Remission During the Treatment Period
|
NA days
No subjects achieved complete remission
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SECONDARY outcome
Timeframe: Baseline to week 12 and week 52Population: Data was not available for all patients at each timepoint
Mean change from baseline in urinary protein:creatinine ratio (UPCR) over time.
Outcome measures
| Measure |
CCX140-B
n=3 Participants
CCX140-B is an orally administered tablet 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.
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|---|---|
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Change From Baseline in Urine Protein:Creatinine Ratio (UPCR) Over Time
Week 12
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-1.3100 g protein/g creatinine
Standard Deviation 3.76247
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|
Change From Baseline in Urine Protein:Creatinine Ratio (UPCR) Over Time
Week 52
|
-0.4985 g protein/g creatinine
Standard Deviation 3.37926
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SECONDARY outcome
Timeframe: Baseline to week 52Partial remission is defined as reduction from baseline by ≥50% in UPCR, reduction in UPCR to a level that was \<3.5 g/g.
Outcome measures
| Measure |
CCX140-B
n=5 Participants
CCX140-B is an orally administered tablet 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.
|
|---|---|
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Assessment of Time to and Proportion of Subjects With Achievement of Partial Remission During the Treatment Period
Partial remission at Week 12
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1 Participants
|
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Assessment of Time to and Proportion of Subjects With Achievement of Partial Remission During the Treatment Period
Did not achieve partial remission
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4 Participants
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SECONDARY outcome
Timeframe: Baseline to week 52Population: Due to the small sample size and early termination of the study, no data could be collected
Based on Investigator or physician initiation of glucocorticoids or new immunosuppressive agents or new major treatment modalities (e.g. plasmapheresis, dialysis)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 12 and Week 52Population: Data was not available for all patients at each timepoint
eGFR-Estimated Glomerular Filtration Rate;CKD-EPI=Chronic Kidney Disease Epidemiology Collaboration
Outcome measures
| Measure |
CCX140-B
n=4 Participants
CCX140-B is an orally administered tablet 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.
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|---|---|
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Mean Change From Baseline for eGFR Using the CKD-EPI Cystatin C Equation Over Time
Week 12
|
7.50 mL/min/1.73m²
Interval -11.0 to 37.0
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Mean Change From Baseline for eGFR Using the CKD-EPI Cystatin C Equation Over Time
Week 52
|
-2.00 mL/min/1.73m²
Interval -2.0 to -2.0
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SECONDARY outcome
Timeframe: Baseline to Week 12 and Week 52Population: Data was not available for all patients at each timepoint
CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate
Outcome measures
| Measure |
CCX140-B
n=4 Participants
CCX140-B is an orally administered tablet 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.
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|---|---|
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Mean Change From Baseline for the eGFR CKD-EPI Creatinine Equation Over Time
Week 12
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-14.50 ml/min/1.73 m²
Interval -27.0 to -6.0
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Mean Change From Baseline for the eGFR CKD-EPI Creatinine Equation Over Time
Week 52
|
-15.0 ml/min/1.73 m²
Interval -15.0 to -15.0
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SECONDARY outcome
Timeframe: Baseline to Week 12 and Week 52Population: Data was not available for all patients at each timepoint
CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate;
Outcome measures
| Measure |
CCX140-B
n=4 Participants
CCX140-B is an orally administered tablet 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.
|
|---|---|
|
Mean Change From Baseline for eGFR CKD-EPI Creatinine-Cystatin C Equation Over Time
Week 52
|
-8.0 ml/min/1.73 m²
Interval -8.0 to -8.0
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|
Mean Change From Baseline for eGFR CKD-EPI Creatinine-Cystatin C Equation Over Time
Week 12
|
-2.25 ml/min/1.73 m²
Interval -18.0 to 13.0
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SECONDARY outcome
Timeframe: Baseline to Week 12 and Week 52Population: Data was not available for all patients at each timepoint
MDRD = Modification of Diet in Renal Disease. The mean eGFR (using the MDRD Creatinine equation) change from baseline to Week 12 and Week 52
Outcome measures
| Measure |
CCX140-B
n=4 Participants
CCX140-B is an orally administered tablet 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.
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|---|---|
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Mean Change From Baseline for the MDRD Creatinine Equation Over Time
Week 12
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-12.75 ml/min/1.73 m²
Interval -24.0 to -5.0
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Mean Change From Baseline for the MDRD Creatinine Equation Over Time
Week 52
|
-13.00 ml/min/1.73 m²
Interval -13.0 to -13.0
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SECONDARY outcome
Timeframe: Baseline to Week 52Population: Due to the small sample size and early termination of the study, no data could be collected
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 12 and Week 52Population: Data was not available for all patients at each timepoint.
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.
Outcome measures
| Measure |
CCX140-B
n=4 Participants
CCX140-B is an orally administered tablet 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.
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|---|---|
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Effect of CCX140-B Treatment on Quality of Life Endpoint EQ-5D-5L for the Overall Trial
Week 52
|
85 score on a scale
Standard Deviation 0
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Effect of CCX140-B Treatment on Quality of Life Endpoint EQ-5D-5L for the Overall Trial
Week 12
|
66.3 score on a scale
Standard Deviation 31.98
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SECONDARY outcome
Timeframe: Baseline to Day 57Population: No data collected
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
Outcome measures
Outcome data not reported
Adverse Events
CCX140-B
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CCX140-B
n=5 participants at risk
CCX140-B is an orally administered tablet. 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.
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|---|---|
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Investigations
Amylase increased
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
|
Investigations
Blood creatine phosphokinase increased
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20.0%
1/5 • Number of events 1 • 52 weeks
|
|
Investigations
Blood potassium increased
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
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Investigations
Lipase increased
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
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General disorders
Fatigue
|
20.0%
1/5 • Number of events 2 • 52 weeks
|
|
General disorders
Oedema peripheral
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
|
General disorders
Pyrexia
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
1/5 • Number of events 2 • 52 weeks
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Pulpitis dental
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
|
Nervous system disorders
Ophthalmoplegic migraine
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 3 • 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 3 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Tongue discomfort
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
|
Renal and urinary disorders
End stage renal disease
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
|
Renal and urinary disorders
Renal impairment
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
20.0%
1/5 • Number of events 1 • 52 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER