Overview

A Study of TRPC5 Channel Inhibitor in Patients With Diabetic Nephropathy, Focal Segmental Glomerulosclerosis, and Treatment-Resistant Minimal Change Disease

Status:
Recruiting
Trial end date:
2022-08-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Goldfinch Bio, Inc.
Criteria
Inclusion Criteria:

- All patients:

1. Male or female 18-75 years of age, of any race, at the time of signing informed
consent.

2. Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 at Screening.

3. Currently receiving an angiotensin-converting enzyme (ACE) inhibitor or
angiotensin receptor blocker (ARB).

- For DN patients:

1. Diagnosis of type 2 diabetes with glycated hemoglobin (HbA1c) level ≤11% at
Screening.

2. UACR ≥ 150 mg/g.

- For FSGS/TR-MCD patients:

1. Diagnosis of FSGS based on either biopsy or genetic testing or TR-MCD based on
biopsy.

2. UPCR ≥ 1.0 g/g.

Exclusion Criteria:

- All patients:

1. Evidence of another (non-DN, non-FSGS/TR-MCD, respectively) kidney disease.

2. 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.

3. History of any organ or bone marrow transplant, including kidney grafts.

4. History of alcoholism or drug/chemical abuse within 12 months prior to Screening.

- For DN patients:

1. Renal disease that requires immunosuppressive therapy (currently, or in the
past).

2. Body mass index (BMI) >45 kg/m2.

- For FSGS/TR-MCD patients:

1. Currently on calcineurin inhibitors or history of resistance to calcineurin
inhibitors.

2. Body mass index (BMI) >40 kg/m2.

3. Known history of severe or chronic hepatobiliary disease.