A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)

• Status: Recruiting
• Trial end date: 2024-02-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

1. Adults age 18 years and older who have a confirmed diagnosis of FSGS.

2. 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.

3. Urine protein:creatinine ratio (UPCR) greater than 1.5 g/g at screening.

4. 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:

1. Diagnosis of collapsing FSGS.

2. Advanced chronic changes on renal biopsy as evidenced by greater than 50% tubulointerstitial fibrosis.

3. Body mass index (BMI) greater than 45 kg/m2.