Trials / Terminated
TerminatedNCT04387448
A Study of TRPC5 Channel Inhibitor in Patients With Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease
A Phase 2a Multiple Ascending, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GFB-887, a TRPC5 Channel Inhibitor, in Patients With Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- Goldfinch Bio, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 2a study evaluating the safety and tolerability of multiple ascending doses of GFB-887 in patients with diabetic nephropathy (DN), focal segmental glomerulosclerosis (FSGS), and treatment-resistant minimal change disease (TR-MCD).
Detailed description
Approximately 125 patients will be enrolled in this study across the United States. Patients with DN and FSGS/TR-MCD will be randomized in 3 ascending dose cohorts to receive either GFB-887 or placebo.
Conditions
- Kidney Diseases
- Diabetic Nephropathies
- Glomerulosclerosis, Focal Segmental
- Nephrosis, Lipoid
- Urologic Diseases
- Diabetes Complications
- Diabetes Mellitus
- Endocrine System Diseases
- Glomerulonephritis
- Nephritis
- Nephrosis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GFB-887 | Investigational Medicinal Product (IMP) |
| DRUG | Placebo | Matching |
Timeline
- Start date
- 2020-07-28
- Primary completion
- 2022-11-01
- Completion
- 2022-11-01
- First posted
- 2020-05-13
- Last updated
- 2022-11-15
Locations
74 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04387448. Inclusion in this directory is not an endorsement.