Open
Actively Recruiting
A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)
About
Brief Summary
The purpose of this Phase 2 adaptive study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06730512 following multiple intravenous infusion in adult subjects with FSGS.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- Adults age 18 years and older who have a confirmed diagnosis of FSGS.
- Estimated glomerular filtration rate (eGFR) greater than or equal to 45 ml/min/1.73 m2. If eGFR is 30 - 45 ml/min/1.73 m2, a recent biopsy (within 12 months prior to Screening) must demonstrate < 50% tubulointerstitial fibrosis.
- Urine protein:creatinine ratio (UPCR) greater than 1.5 g/g at screening.
- Treated with at least one but not more than 3 classes of immunosuppressants either alone or in combination, or has a contraindication to use of an immunosuppressant or is intolerant to an immunosuppressant per investigator judgment
Exclusion Criteria:
- Diagnosis of collapsing FSGS.
- Advanced chronic changes on renal biopsy as evidenced by greater than 50% tubulointerstitial fibrosis.
- Body mass index (BMI) greater than 45 kg/m2.
Join this Trial
Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
18-000534
Category
Nephrology
Principal Investigator
Contact
Location
- UCLA Westwood