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

• Status: Recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Goldfinch Bio, Inc.

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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