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PODO
Description
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.
Is there compensation for this trial? Yes
Am I Eligible or this trial?
Below is the detailed inclusion and exclusion detail for the the trial. Some of these you may know and other we may need to test in order to determine if you are a good fit for the trial. If you are not sure, please fill out the form to the left and one of our researchers will call you to assist in determining this and answering any additional questions.
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.