Study Stopped
Business reasons
An Open-Label, Long-term Study of GFB-887 in Patients With Glomerular Kidney Diseases
1 other identifier
interventional
31
1 country
17
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2021
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2021
CompletedFirst Posted
Study publicly available on registry
July 6, 2021
CompletedStudy Start
First participant enrolled
July 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2022
CompletedNovember 15, 2022
November 1, 2022
1.3 years
June 25, 2021
November 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence and severity of adverse events
Incidence and severity of adverse events
Approximately 3 years
Secondary Outcomes (12)
Percent reduction in urine protein:creatinine ratio (UPCR) from baseline
Approximately 3 years
Proportion of participants achieving modified partial remission status
Approximately 3 years
Proportion of participants achieving complete remission status
Approximately 3 years
Proportion of participants with a UPCR decrease of at least 30% from baseline
Approximately 3 years
Proportion of participants with a UPCR decrease of at least 40% from baseline
Approximately 3 years
- +7 more secondary outcomes
Study Arms (1)
200 mg Dose Cohort
EXPERIMENTALParticipants who received GFB-887 or placebo in GFB-887-201 will receive GFB-887 at a daily dose level of 200 mg regardless of original dose level.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Academic Medical Research Institute (AMRI)
Los Angeles, California, 90022, United States
Amicis Research Center
Northridge, California, 91324, United States
Kidney and Hypertension Center - Apple Valley
Victorville, California, 92395, United States
University of Colorado Anschutz Medical Center
Aurora, Colorado, 80045, United States
Colorado Kidney Care (Denver Nephrology)
Denver, Colorado, 80230, United States
Boise Kidney and Hypertension Institute
Nampa, Idaho, 83687, United States
NANI Research, LLC
Hinsdale, Illinois, 60521, United States
St. Clair Nephrology
Roseville, Michigan, 48066, United States
Clinical Research Consultants
Kansas City, Missouri, 64111, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, 37404-2743, United States
Prolato Clinical Research Center
Houston, Texas, 77054, United States
Clinical Advancement Center, PLLC
San Antonio, Texas, 78212, United States
Tranquility Research
Webster, Texas, 77598, United States
Utah Kidney Center
Salt Lake City, Utah, 84115, United States
Providence Medical Research Center
Spokane, Washington, 99204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2021
First Posted
July 6, 2021
Study Start
July 27, 2021
Primary Completion
November 2, 2022
Study Completion
November 2, 2022
Last Updated
November 15, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share