A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)
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.
- Focal Segmental Glomerulosclerosis (FSGS)
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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
- 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.
- Phase 2
- Study Type
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Triple (Participant, Care Provider, Investigator)
- Masking Description
- Open label
PF-06730512 Cohort 1
|Subjects in cohort 1 will receive dose 1 Intravenous (IV) infusion.||
PF-06730512 Cohort 2
|Subjects in cohort 2 will receive dose 2 IV infusion.||
Study ContactPfizer CT.gov Call Center