Purpose

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).

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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) ≥ 45 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 ≤10% 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. Body mass index (BMI) >40 kg/m2. 3. 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. 4. History of any organ or bone marrow transplant, including kidney grafts. 5. 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). - For FSGS/TR-MCD patients: 1. Currently on calcineurin inhibitors or history of resistance to calcineurin inhibitors. 2. Known history of severe or chronic hepatobiliary disease.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Multiple-ascending, placebo-controlled
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
GFB-887 multiple ascending dose (MAD) active
GFB-887 active once-daily dosing
  • Drug: GFB-887
    Investigational Medicinal Product (IMP)
Placebo Comparator
GFB-887 MAD placebo
GFB-887 placebo once-daily dosing
  • Drug: Placebo
    Matching

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Shinieka Wilson
615-936-1180
shinieka.l.wilson@vumc.org

More Details

Status
Recruiting
Sponsor
Goldfinch Bio, Inc.

Study Contact

Goldfinch Bio Clinical Trials Information
(617) 337-4000
clinicaltrials@goldfinchbio.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.