Status:
TERMINATED
A Study of TRPC5 Channel Inhibitor in Patients With Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease
Lead Sponsor:
Goldfinch Bio, Inc.
Conditions:
Kidney Diseases
Diabetic Nephropathies
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 treatm...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2022
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04387448
Start Date
July 28 2020
End Date
November 1 2022
Last Update
November 15 2022
Active Locations (74)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35392
2
Aventiv Research - Phoenix
Mesa, Arizona, United States, 85210-6041
3
Arizona Kidney Disease & Hypertension Centers (AKDHC)
Scottsdale, Arizona, United States, 85258
4
Academic Medical Research Institute (AMRI)
Glendale, California, United States, 90022