drugset / Trial / NCT03422510
FIRSTx - A Study of Oral CXA-10 in Primary Focal Segmental Glomerulosclerosis (FSGS)
Phase 2
Completed
33 enrolled
Complexa, Inc.
Arkana Labs · collabKidney Research Network, formerly NephCure Accelerating Cures Institute · collabMedpace, Inc. · collabMicroConstants · collabNephCure Kidney International · collab
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2018-04-15
- Primary completion
- 2020-07-31
- Completion
- 2020-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CXA-10 | Small molecule | 75 mg | Oral |
| Subject | CXA-10 | Small molecule | 150 mg | Oral |
| Subject | CXA-10 | Small molecule | 300 mg | Oral |