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A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)

NCT03448692•Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this Phase 2 adaptive study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06730512 following multiple intravenous infusions in adult subjects with FSGS.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adults age 18 years and older who have a confirmed biopsy 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. Organ transplant.
•4. 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.
•5. Body mass index (BMI) greater than 45 kg/m2.
•6. 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.

Locations (110)

The Kirklin Clinic of University Alabama Birmingham Hospital

Birmingham, Alabama, United States

Investigational Drug Service Pharmacy UAB Hosptial

Birmingham, Alabama, United States

Clinical Research Unit at UAB Hospital

Birmingham, Alabama, United States

UAB Nephrology Research Clinic at Paula Building

Birmingham, Alabama, United States

Academic Medical Research Institute