Nephrology: Clinical Research Program

Inclusion Criteria 

1. Male or female, aged ≥ 18 years.
2. Willing and able to provide signed informed consent prior to any screening procedures.
3. UPCR ≥1 g/g during screening.
4. On maximally tolerated ACEi or ARB per PI discretion within 1 month of informed consent.
5. Estimated glomerular filtration rate ≥25 ml/min/1.73m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
6. Kidney biopsy within 3 years of screening consistent with FSGS or documentation of a genetic mutation in a podocyte protein associated with FSGS.

Exclusion Criteria 

1. Collapsing FSGS in the kidney biopsy report used to determine eligibility.
2. UPCR > 15 g/g at screening.
3. FSGS secondary to another condition.
4. History of any glomerulonephritis or glomerulopathy other than FSGS or minimal change disease.
5. Sickle cell disease.
6. History of type 1 diabetes mellitus, uncontrolled T2DM (glycated hemoglobin [HbA1c] >8%), or non-fasting blood glucose >180 mg/dL.
7. Uncontrolled hypertension with mean seated systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg based on the average of 2 measurements obtained at approximately 2-minute intervals after the individual has been sitting for 5 minutes.
8. Participants with body mass index ≥45.
9. Positive at screening for human immunodeficiency virus (HIV) markers or markers indicating acute or chronic hepatitis B virus (HBV) infection or hepatitis C virus (HCV) infection:

1. Acute HBV defined as a positive hepatitis B surface antigen [HBsAg], hepatitis B “e” antigen [HBeAg], HBV deoxyribonucleic acid (DNA) in blood or liver, or immunoglobulin M [IgM] hepatitis B core antibody.
2. Chronic HBV defined as a positive HBsAg and/or HBeAg and/or HBV DNA.
3. HCV infection defined as reactive anti-HCV antibody and/or HCV ribonucleic acid (RNA).

10. Known cirrhosis or active, acute liver disease, or aspartate aminotransferase (AST), alanine aminotransferase (ALT) >3x upper limit of normal (ULN) or bilirubin >1.5x ULN at screening. Individuals with a history of Gilbert’s syndrome are not excluded.
11. Active alcoholism or illicit substance use (except cannabidiol [CBD]/ tetrahydrocannabinol [THC]) at the investigator’s discretion.
12. Previous or anticipated solid-organ, hematopoietic stem cell or bone marrow transplantation in the next 12 months.
13. HCV infection defined as reactive anti-HCV antibody and/or HCV ribonucleic acid (RNA).

Enrollment Status: Open to Enrollment

Study Information: NCT07268638

Principal Investigator: Savneek Chugh, MD

Contact for Study Screening: [email protected]