Trials / Completed
CompletedNCT03422510
FIRSTx - A Study of Oral CXA-10 in Primary Focal Segmental Glomerulosclerosis (FSGS)
A Phase 2 Multicenter, Open Label, Randomized Study of Two Titration Regimens of Oral CXA-10 in Subjects With Primary Focal Segmental Glomerulosclerosis (FSGS)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Complexa, Inc. · Industry
- Sex
- All
- Age
- 13 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, open label, randomized study investigating two dose titration regimens of CXA-10 in subjects at least 18 years of age with primary FSGS. The study will be performed at approximately 25 study centers across the United States of America (USA). The recruitment period is anticipated to be up to approximately 16 months. Approximately 30 subjects will be randomized to ensure 26 subjects complete the study. An optional 9 month open label is available
Detailed description
This is a multicenter, open label, randomized study investigating two dose titration regimens of CXA-10 in subjects at least 18 years of age with primary FSGS. The study will be performed at approximately 25 study centers across the United States of America (USA). The recruitment period is anticipated to be up to approximately 16 months. Approximately 30 subjects will be randomized. Study participation for each subject will last up to 5 months. The study will consist of a screening period not to exceed 30 days (1 month), 90-day (3 month) treatment period, and an approximate 28-day (1 month) follow-up period after the last dose of study medication. An optional 9 month open label is available.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CXA-10 | CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitro-oleic acid (OA-NO2) |
Timeline
- Start date
- 2018-04-15
- Primary completion
- 2020-07-31
- Completion
- 2020-07-31
- First posted
- 2018-02-05
- Last updated
- 2020-08-03
Locations
24 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03422510. Inclusion in this directory is not an endorsement.