An Open-Label, Long-term Study of GFB-887 in Patients With Glomerular Kidney Diseases

Stopped early · Phase 2

Conditions studied: Kidney Diseases, Glomerulosclerosis, Focal Segmental Nephrosis, Lipoid Urologic Disease, Glomerulonephritis, Nephritis, Nephrosis

In brief

This is an open-label Phase 2 study evaluating the long term safety and tolerability of GFB-887 in patients with focal segmental glomerulosclerosis (FSGS), and treatment-resistant minimal change disease (TR-MCD)

Key facts

Study ID

NCT04950114

Run by

Goldfinch Bio, Inc.

People needed

31

Starts

2021-07-27

Expected to finish

2022-11-02

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…

• Participants with FSGS/TR-MCD who have completed the treatment phase from an interventional clinical study with GFB-887. Participants who were discontinued for rising proteinuria from a GFB-887 interventional study may be considered for enrollment following consultation with the Medical Monitor.
• Participants who enrolled in any other interventional study during the time between completion of the prior GFB-887 interventional study and this study may be considered for enrollment following consultation with the Medical Monitor.

You may not qualify if…

• Participant is unable to take oral medications
• Participant has an unstable medical condition based on medical history, physical examination, laboratory tests, ECGs, vital signs or is otherwise unstable in the judgement of the Investigator which would pose a risk to the participant or interfere with study evaluation, procedures, or completion
• Evidence of significant hypersensitivity, intolerance, or allergy to any component of investigational product GFB-887

Where it is running

• Academic Medical Research Institute (AMRI) — Los Angeles, California, United States
• Amicis Research Center — Northridge, California, United States
• Kidney and Hypertension Center - Apple Valley — Victorville, California, United States
• University of Colorado Anschutz Medical Center — Aurora, Colorado, United States
• Colorado Kidney Care (Denver Nephrology) — Denver, Colorado, United States
• Boise Kidney and Hypertension Institute — Nampa, Idaho, United States
• NANI Research, LLC — Hinsdale, Illinois, United States
• St. Clair Nephrology — Roseville, Michigan, United States
• Clinical Research Consultants — Kansas City, Missouri, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Southeast Renal Research Institute — Chattanooga, Tennessee, United States
• Prolato Clinical Research Center — Houston, Texas, United States
• Clinical Advancement Center, PLLC — San Antonio, Texas, United States
• Tranquility Research — Webster, Texas, United States
• Utah Kidney Center — Salt Lake City, Utah, United States
• Providence Medical Research Center — Spokane, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.