Trial · NCT03703908
A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome
NCT03703908, Phase 2, Terminated, Amgen; results first posted 2024-02-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome. Trials, record NCT03703908. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03703908
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome
- NCT number
- NCT03703908
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Focal Segmental Glomerulosclerosis
- Interventions
- CCX140-B
- First posted
- 2018-10-12
- Last updated
- 2025-03-17
- Results first posted
- 2024-02-06
- Limitations and caveats
- The CL012\_140 study was terminated early due to lack of efficacy in another study, CL011\_140, investigating the use of CCX140-B.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Subjects With a Reduction in Urine Protein to Creatinine Ratio (UPCR) of at Least 20% | Baseline to week 12 | Number of subjects with a reduction in Urine Protein to Creatinine Ratio (UPCR) of at least 20% , i.e., ≥20%, by Week 12. |
| Secondary | Achievement of Partial or Complete Remission of UPCR Through Week 12 and Through the End of Treatment | Baseline to week 12 | 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 |
| Secondary | Proportion of Subjects With Achievement of Complete Remission During the Treatment Period | Baseline to week 52 | 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. |
| Secondary | Time Taken of Subjects to Achieve Complete Remission During the Treatment Period | Baseline to week 52 | 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. |
| Secondary | Change From Baseline in Urine Protein:Creatinine Ratio (UPCR) Over Time | Baseline to week 12 and week 52 | Mean change from baseline in urinary protein:creatinine ratio (UPCR) over time. |
| Secondary | Assessment of Time to and Proportion of Subjects With Achievement of Partial Remission During the Treatment Period | Baseline to week 52 | Partial remission is defined as reduction from baseline by ≥50% in UPCR, reduction in UPCR to a level that was \<3.5 g/g. |
| Secondary | Time to Rescue Therapy | Baseline to week 52 | Based on Investigator or physician initiation of glucocorticoids or new immunosuppressive agents or new major treatment modalities (e.g. plasmapheresis, dialysis) |
| Secondary | Mean Change From Baseline for eGFR Using the CKD-EPI Cystatin C Equation Over Time | Baseline to Week 12 and Week 52 | eGFR-Estimated Glomerular Filtration Rate;CKD-EPI=Chronic Kidney Disease Epidemiology Collaboration |
| Secondary | Mean Change From Baseline for the eGFR CKD-EPI Creatinine Equation Over Time | Baseline to Week 12 and Week 52 | CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate |
| Secondary | Mean Change From Baseline for eGFR CKD-EPI Creatinine-Cystatin C Equation Over Time | Baseline to Week 12 and Week 52 | CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate; |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Subjects With a Reduction in Urine Protein to Creatinine Ratio (UPCR) of at Least 20% | Baseline to week 12 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Achievement of Partial or Complete Remission of UPCR Through Week 12 and Through the End of Treatment | Baseline to week 12 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Subjects With Achievement of Complete Remission During the Treatment Period | Baseline to week 52 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time Taken of Subjects to Achieve Complete Remission During the Treatment Period | Baseline to week 52 | days | NUMBER | |
| SECONDARY | Change From Baseline in Urine Protein:Creatinine Ratio (UPCR) Over Time | Baseline to week 12 and week 52 | Data was not available for all patients at each timepoint | g protein/g creatinine | MEAN |
| SECONDARY | Assessment of Time to and Proportion of Subjects With Achievement of Partial Remission During the Treatment Period | Baseline to week 52 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Rescue Therapy | Baseline to week 52 | Due to the small sample size and early termination of the study, no data could be collected | ||
| SECONDARY | Mean Change From Baseline for eGFR Using the CKD-EPI Cystatin C Equation Over Time | Baseline to Week 12 and Week 52 | Data was not available for all patients at each timepoint | mL/min/1.73m² | MEAN |
| SECONDARY | Mean Change From Baseline for the eGFR CKD-EPI Creatinine Equation Over Time | Baseline to Week 12 and Week 52 | Data was not available for all patients at each timepoint | ml/min/1.73 m² | MEAN |
| SECONDARY | Mean Change From Baseline for eGFR CKD-EPI Creatinine-Cystatin C Equation Over Time | Baseline to Week 12 and Week 52 | Data was not available for all patients at each timepoint | ml/min/1.73 m² | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Subjects With a Reduction in Urine Protein to Creatinine Ratio (UPCR) of at Least 20% | CCX140-B | 2 | Participants | ||
| Achievement of Partial or Complete Remission of UPCR Through Week 12 and Through the End of Treatment | CCX140-B | No Complete or Partial remission at week 12/ end of treatment | 4 | Participants | |
| Achievement of Partial or Complete Remission of UPCR Through Week 12 and Through the End of Treatment | CCX140-B | Partial remission at Week 12 | 1 | Participants | |
| Proportion of Subjects With Achievement of Complete Remission During the Treatment Period | CCX140-B | Achieved complete remission | 0 | Participants | |
| Proportion of Subjects With Achievement of Complete Remission During the Treatment Period | CCX140-B | Did not achieve complete remission | 5 | Participants | |
| Time Taken of Subjects to Achieve Complete Remission During the Treatment Period | CCX140-B | NA | days | ||
| Change From Baseline in Urine Protein:Creatinine Ratio (UPCR) Over Time | CCX140-B | Week 12 | -1.3100 | Standard Deviation 3.76247 | g protein/g creatinine |
| Change From Baseline in Urine Protein:Creatinine Ratio (UPCR) Over Time | CCX140-B | Week 52 | -0.4985 | Standard Deviation 3.37926 | g protein/g creatinine |
| Assessment of Time to and Proportion of Subjects With Achievement of Partial Remission During the Treatment Period | CCX140-B | Partial remission at Week 12 | 1 | Participants | |
| Assessment of Time to and Proportion of Subjects With Achievement of Partial Remission During the Treatment Period | CCX140-B | Did not achieve partial remission | 4 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CCX140-B | 5 | |
| Overall Study | COMPLETED | CCX140-B | 2 | |
| Overall Study | NOT COMPLETED | CCX140-B | 3 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Amylase increased | Investigations | CCX140-B | 1 | 5 | 1 |
| other | Blood creatine phosphokinase increased | Investigations | CCX140-B | 1 | 5 | 1 |
| other | Blood potassium increased | Investigations | CCX140-B | 1 | 5 | 1 |
| other | Lipase increased | Investigations | CCX140-B | 1 | 5 | 1 |
| other | Fatigue | General disorders | CCX140-B | 1 | 5 | 2 |
| other | Oedema peripheral | General disorders | CCX140-B | 1 | 5 | 1 |
| other | Pyrexia | General disorders | CCX140-B | 1 | 5 | 1 |
| other | Upper respiratory tract infection | Infections and infestations | CCX140-B | 1 | 5 | 2 |
| other | Nasopharyngitis | Infections and infestations | CCX140-B | 1 | 5 | 1 |
| other | Pulpitis dental | Infections and infestations | CCX140-B | 1 | 5 | 1 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CCX140-B | 0 | 5 |
| Total, other adverse events | CCX140-B | 4 | 5 |
| Total, serious adverse events | CCX140-B | 0 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03703908
GET https://conductscience.org/api/trials/v1/NCT03703908/events?page=2