Trial · NCT03536754
A Study of CCX140-B in Subjects With FSGS
NCT03536754, Phase 2, Completed, Amgen; results first posted 2023-12-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of CCX140-B in Subjects With FSGS. Trials, record NCT03536754. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03536754
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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 FSGS
- NCT number
- NCT03536754
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- Amgen
- Conditions
- FSGS, Focal Segmental Glomerulosclerosis, Glomerulosclerosis
- Interventions
- Placebo, CCX140-B, CCX140-B, CCX140-B
- First posted
- 2018-05-25
- Last updated
- 2025-03-13
- Results first posted
- 2023-12-05
- Limitations and caveats
- Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
Source ClinicalTrials.gov
Registered outcomes56
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in UPCR at Week 12 | Baseline to Week 12 | Least squared mean ratio of UPCR (Urine protein g:creatinine g) compared to baseline at Week 12 in the ITT population. ITT- Intent to treat |
| Primary | Number of Participants of Treatment-emergent AEs (TEAE), TEAEs Leading to Study Withdrawal, and Serious Adverse Events (SAEs) | Baseline to Week 12, and Week 12 to Week 24 | TEAEs leading to study withdrawal means study drug discontinuation in this endpoint. |
| Primary | Change From Baseline in Activated Partial Thromboplastin Time | Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension) | Normal Range: 23.9 - 40.0 |
| Primary | Change From Baseline in Plasma Alanine Aminotransferase | Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension) | Normal Range: 6 - 41 U/L |
| Primary | Change From Baseline in Plasma Alkaline Phosphatase | Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension) | |
| Primary | Change From Baseline in Plasma Amylase | Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension) | Normal range: 22-123 U/L |
| Primary | Change From Baseline in Plasma Aspartate Aminotransferase | Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension) | Normal range : 9-34 U/L |
| Primary | Change From Baseline in Plasma Bicarbonate | Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension) | Normal range: 21-33 mmol/L |
| Primary | Change From Baseline in Plasma Bilirubin | Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension) | Normal range: 0.1-1.10 mg/dL |
| Primary | Change From Baseline in Plasma C Reactive Protein | Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension) | Normal range: 0.0-3.0 mg/L |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 registered outcomesOutcomes56
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in UPCR at Week 12 | Baseline to Week 12 | g protein/g creatinine | LEAST_SQUARES_MEAN | |
| PRIMARY | Number of Participants of Treatment-emergent AEs (TEAE), TEAEs Leading to Study Withdrawal, and Serious Adverse Events (SAEs) | Baseline to Week 12, and Week 12 to Week 24 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Change From Baseline in Activated Partial Thromboplastin Time | Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension) | Data is not available for all participants. | second | MEAN |
| PRIMARY | Change From Baseline in Plasma Alanine Aminotransferase | Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension) | U/L | MEAN | |
| PRIMARY | Change From Baseline in Plasma Alkaline Phosphatase | Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension) | U/L | MEAN | |
| PRIMARY | Change From Baseline in Plasma Amylase | Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension) | U/L | MEAN | |
| PRIMARY | Change From Baseline in Plasma Aspartate Aminotransferase | Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension) | U/L | MEAN | |
| PRIMARY | Change From Baseline in Plasma Bicarbonate | Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension) | mmol/L | MEAN | |
| PRIMARY | Change From Baseline in Plasma Bilirubin | Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension) | mg/dL | MEAN | |
| PRIMARY | Change From Baseline in Plasma C Reactive Protein | Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension) | mg/L | MEAN |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 outcomesResults by group339
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in UPCR at Week 12 | Placebo | 0.83 | 90% Confidence Interval 0.69 to 0.99 | g protein/g creatinine | |
| Change From Baseline in UPCR at Week 12 | CCX140-B 5 mg Once Daily | 1.02 | 90% Confidence Interval 0.84 to 1.23 | g protein/g creatinine | |
| Change From Baseline in UPCR at Week 12 | CCX140-B 10 mg Twice Daily | 1.12 | 90% Confidence Interval 0.93 to 1.35 | g protein/g creatinine | |
| Change From Baseline in UPCR at Week 12 | CCX140-B 15 mg Twice Daily | 0.87 | 90% Confidence Interval 0.72 to 1.05 | g protein/g creatinine | |
| Number of Participants of Treatment-emergent AEs (TEAE), TEAEs Leading to Study Withdrawal, and Serious Adverse Events (SAEs) | Placebo | TEAEs | 10 | Participants | |
| Number of Participants of Treatment-emergent AEs (TEAE), TEAEs Leading to Study Withdrawal, and Serious Adverse Events (SAEs) | CCX140-B 5 mg Once Daily | TEAEs | 6 | Participants | |
| Number of Participants of Treatment-emergent AEs (TEAE), TEAEs Leading to Study Withdrawal, and Serious Adverse Events (SAEs) | CCX140-B 10 mg Twice Daily | TEAEs | 8 | Participants | |
| Number of Participants of Treatment-emergent AEs (TEAE), TEAEs Leading to Study Withdrawal, and Serious Adverse Events (SAEs) | CCX140-B 15 mg Twice Daily | TEAEs | 7 | Participants | |
| Number of Participants of Treatment-emergent AEs (TEAE), TEAEs Leading to Study Withdrawal, and Serious Adverse Events (SAEs) | Open-label Extension | TEAEs | 24 | Participants | |
| Number of Participants of Treatment-emergent AEs (TEAE), TEAEs Leading to Study Withdrawal, and Serious Adverse Events (SAEs) | Placebo | SAEs | 0 | Participants |
1 to 10 of 339Source ClinicalTrials.gov
See all 339 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double Blind Period 1 | STARTED | Placebo | 12 | |
| Double Blind Period 1 | STARTED | CCX140-B 5 mg Once Daily | 11 | |
| Double Blind Period 1 | STARTED | CCX140-B 10 mg Twice Daily | 12 | |
| Double Blind Period 1 | STARTED | CCX140-B 15 mg Twice Daily | 11 | |
| Double Blind Period 1 | STARTED | Open-label Extension | 0 | |
| Double Blind Period 1 | COMPLETED | Placebo | 12 | |
| Double Blind Period 1 | COMPLETED | CCX140-B 5 mg Once Daily | 11 | |
| Double Blind Period 1 | COMPLETED | CCX140-B 10 mg Twice Daily | 11 | |
| Double Blind Period 1 | COMPLETED | CCX140-B 15 mg Twice Daily | 11 | |
| Double Blind Period 1 | COMPLETED | Open-label Extension | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events800
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 | Nasopharyngitis | Infections and infestations | Placebo | 1 | 11 | 1 |
| other | Nasopharyngitis | Infections and infestations | CCX140-B 5 mg | 2 | 11 | 2 |
| other | Nasopharyngitis | Infections and infestations | CCX140-B 10 mg | 1 | 12 | 1 |
| other | Nasopharyngitis | Infections and infestations | CCX140-B 15 mg | 0 | 11 | 0 |
| other | Nasopharyngitis | Infections and infestations | Placebo Open Label | 1 | 11 | 1 |
| other | Nasopharyngitis | Infections and infestations | CCX140-B 5mg Open Label | 1 | 11 | 1 |
| other | Nasopharyngitis | Infections and infestations | CCX140-B 10mg Open Label | 0 | 11 | 0 |
| other | Nasopharyngitis | Infections and infestations | CCX140-B 15mg Open Label | 0 | 10 | 0 |
| other | Bronchitis | Infections and infestations | Placebo | 0 | 11 | 0 |
| other | Bronchitis | Infections and infestations | CCX140-B 5 mg | 2 | 11 | 2 |
1 to 10 of 800Source ClinicalTrials.gov
See all 800 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 11 |
| Total, all-cause mortality | CCX140-B 5 mg | 0 | 11 |
| Total, all-cause mortality | CCX140-B 10 mg | 0 | 12 |
| Total, all-cause mortality | CCX140-B 15 mg | 0 | 11 |
| Total, all-cause mortality | Placebo Open Label | 0 | 11 |
| Total, all-cause mortality | CCX140-B 5mg Open Label | 0 | 11 |
| Total, all-cause mortality | CCX140-B 10mg Open Label | 0 | 11 |
| Total, all-cause mortality | CCX140-B 15mg Open Label | 0 | 10 |
| Total, other adverse events | Placebo | 7 | 11 |
| Total, other adverse events | CCX140-B 5 mg | 8 | 11 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35224732 | DERIVED |
Source PubMed
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/NCT03536754
GET https://conductscience.org/api/trials/v1/NCT03536754/registered?page=2