Trials / Completed
CompletedNCT03536754
A Study of CCX140-B in Subjects With FSGS
A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Focal Segmental Glomerulosclerosis (FSGS)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with FSGS to be conducted in the North America, Europe and Australia
Detailed description
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Focal Segmental Glomerulosclerosis (FSGS) to be conducted in the North America, Europe and Australia. The aim of this study is to evaluate the effect of treatment with CCX140-B, a selective antagonist of C-C chemokine receptor type 2 in subjects with focal segmental glomerulosclerosis on urinary protein excretion as assessed by changes in urine protein to creatinine ratio (UPCR). Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Placebo | Three placebo tablets, taken twice daily (BID), per os, for 84 days (12 weeks) |
| DRUG | CCX140-B | One 5 mg CCX140-B tablet and 2 placebo tablets in the morning; 3 placebo tablets in the evening; per os, for 84 days. |
| DRUG | CCX140-B | Two 5 mg CCX140-B tablets and 1 placebo tablet, taken BID; per os, for 84 days. |
| DRUG | CCX140-B | Three 5 mg CCX140-B tablets, taken BID; per os, for 84 days. |
Timeline
- Start date
- 2018-05-17
- Primary completion
- 2020-02-19
- Completion
- 2020-02-19
- First posted
- 2018-05-25
- Last updated
- 2025-03-13
- Results posted
- 2023-12-05
Locations
37 sites across 8 countries: United States, Australia, Canada, France, Italy, New Zealand, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03536754. Inclusion in this directory is not an endorsement.