This study looks at whether the drug GFB-887 (developed by Goldfinch Bio) can slow the progression of kidney disease in patients with FSGS and treatment-resistant minimal change disease. The drug works similarly to drugs called calcineurin inhibitors (aka CNIs, such as tacrolimus or cyclosporine) but without some of the side effects those drugs can have. This study is double blind and placebo controlled, meaning that neither you nor the study team will know if you are assigned to take the real drug or a fake pill. Once you complete this study, you will have the option to enroll in an additional study where all participants receive the drug.
Inclusion Criteria
- Age 18 or older
- Diagnosis of Focal Segemental Glomerularsclerosis (FSGS), or Treatment-Resistant Minimal Change Disease
- History of protein in urine (if you don't know, we will test it)
- You must agree to use birth control for the duration of the study
If you aren't sure you qualify, please call us and we will help determine your eligibility.
Exclusion Criteria
- Uncontrolled blood pressure (systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg)
- Pregnant or breastfeeding
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2 × upper normal limit, or a known history of severe or chronic hepatobiliary disease.
Study Requirements
The study is about 7 months long. There are about 11 visits over the 7 months, most of which are about 1.5 hours, and 2 of which take 8 hours, during which you can read or use a computer. For some (but not all) visits, you can arrange to have a nurse come conduct them in your home instead of coming into the hospital.
