A Study of TRPC5 Channel Inhibitor in Patients With Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Kidney Diseases, Diabetic Nephropathies, Glomerulosclerosis, Focal Segmental, Nephrosis, Lipoid, Urologic Diseases, Diabetes Complications, Diabetes Mellitus, Endocrine System Diseases, Glomerulonephritis, Nephritis, Nephrosis
In brief
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).
Key facts
- Study ID
- NCT04387448
- Run by
- Goldfinch Bio, Inc.
- People needed
- 96
- Starts
- 2020-07-28
- Expected to finish
- 2022-11-01
- Last updated by the study team
- 2022-11-15
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All patients:
- Male or female 18-75 years of age, of any race, at the time of signing informed consent.
- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 at Screening.
- Currently receiving an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).
- For DN patients:
- Diagnosis of type 2 diabetes with glycated hemoglobin (HbA1c) level ≤11% at Screening.
- UACR ≥ 150 mg/g.
- For FSGS/TR-MCD patients:
- Diagnosis of FSGS based on either biopsy or genetic testing or TR-MCD based on biopsy.
- UPCR ≥ 1.0 g/g.
You may not qualify if…
- All patients:
- Evidence of another (non-DN, non-FSGS/TR-MCD, respectively) kidney disease.
- History of malignancy, unless in remission for at least 5 years other than adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or prostate cancer not expected to require treatment over the course of the study.
- History of any organ or bone marrow transplant, including kidney grafts.
- History of alcoholism or drug/chemical abuse within 12 months prior to Screening.
- For DN patients:
- Renal disease that requires immunosuppressive therapy (currently, or in the past).
- Body mass index (BMI) >45 kg/m2.
- For FSGS/TR-MCD patients:
- Currently on calcineurin inhibitors or history of resistance to calcineurin inhibitors.
- Body mass index (BMI) >40 kg/m2.
- Known history of severe or chronic hepatobiliary disease.
Where it is running
- Aventiv Research - Phoenix — Mesa, Arizona, United States
- Arizona Kidney Disease & Hypertension Centers (AKDHC) — Scottsdale, Arizona, United States
- Academic Medical Research Institute (AMRI) — Glendale, California, United States
- Amicis Research Center — Granada Hills, California, United States
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- Amicis Research Center — Northridge, California, United States
- Valley Renal Medical Group — Northridge, California, United States
- Respire Research - Palm Springs — Palm Springs, California, United States
- North American Research Institute — San Dimas, California, United States
- Dr. Malvin Yan Inc. — South Gate, California, United States
- Valiance Clinical Research - Tarzana — Tarzana, California, United States
- Amicis Research Center — Vacaville, California, United States
- DaVita Mojave Sage Dialysis — Victorville, California, United States
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
- Colorado Kidney Care (Denver Nephrology) — Denver, Colorado, United States
- Western Nephrology - Westminster — Wheat Ridge, Colorado, United States
- DaVita Hartford North — Hartford, Connecticut, United States
- Nephrology Associationes, P.A. — Newark, Delaware, United States
- Prohealth Research Center - Doral — Doral, Florida, United States
- Clinical Site Partners Leesburg, LLC — Leesburg, Florida, United States
- Premier Clinical Research Institute — Miami, Florida, United States
- Kidney & Hypertension Specialists of Miami — Miami, Florida, United States
- Avanza Medical Research Center — Pensacola, Florida, United States
- Coastal Nephrology Associates Research Center, LLC — Port Charlotte, Florida, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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