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

Stopped early · Phase 2

Conditions studied: Focal Segmental Glomerulosclerosis (FSGS)

In brief

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.

Key facts

Study ID

NCT03448692

Run by

Pfizer

People needed

47

Starts

2018-10-15

Expected to finish

2023-02-14

Last updated by the study team

2024-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults age 18 years and older who have a confirmed biopsy 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.

You may not qualify if…

• 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.

Where it is running

• 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 — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Cedars-Sinai Ambulatory Infusion Center — Los Angeles, California, United States
• Cedars-Sinai Comprehensive Transplant Center — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UCLA Clinical and Translational Research Center — Los Angeles, California, United States
• UCLA Department of Medicine — Los Angeles, California, United States
• Clinical and Translation Research Unit — Palo Alto, California, United States
• Stanford University-Nephrology Division — Palo Alto, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Stanford Health Care Investigational Pharmacy — Stanford, California, United States
• Stanford University-Nephrology Division — Stanford, California, United States
• Stanford University — Stanford, California, United States
• Yale Center for Clinical Investigation Hospital Research Unit — New Haven, Connecticut, United States
• Yale Nephrology Clinical Research Clinic — New Haven, Connecticut, United States
• Yale University School of Medicine - Yale-New Haven Hospital — New Haven, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Yale Center for Clinical Investigation - Church Street Research Unit — New Haven, Connecticut, United States
• University of Miami Hospital and Clinics — Miami, Florida, United States
• University of Miami Katz Family Division of Nephrology — Miami, Florida, United States
• The Kirklin Clinic of University Alabama Birmingham Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.