An Open-Label, Long-term Study of GFB-887 in Patients With Glomerular Kidney Diseases (NCT04950114) | Clinical Trial Compass
TerminatedPhase 2
An Open-Label, Long-term Study of GFB-887 in Patients With Glomerular Kidney Diseases
Stopped: Business reasons
United States31 participantsStarted 2021-07-27
Plain-language 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)
Who can participate
Age range18 Years – 75 Years
SexALL
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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