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

ID#: NCT04950114

Age: 18 - 75 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: July 27, 2021

End Date: September 01, 2025

Contact Information:
Goldfinch Bio Clinical Trials Information
617-337-4200
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)
Eligibility:

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
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