A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) (PODO)
Completed
- Conditions
- Focal Segmental Glomerulosclerosis (FSGS)
- Registration Number
- jRCT2021200032
- Lead Sponsor
- Pfizer Japan Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 44
Inclusion 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
- Diagnosis of collapsing FSGS.
- Advanced chronic changes on renal biopsy as evidenced by greater than 50% tubulointerstitial fibrosis.
- Organ transplant.
- History of malignancy, with the exception of basal or squamous cell carcinoma that has been treated and fully resolved for a minimum of 5 years.
- Body mass index (BMI) greater than 45 kg/m2.
- Subjects with a history of prior treatment with or use of interferon, lithium, pamidronate, mTOR inhibitors (eg, sirolimus), testosterone/anabolic steroids, anthracycline (eg, doxorubicin), heroin.
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method