Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
The PODO Trial for FSGS Patients
Trial To Evaluate PF-06730512 In Adults With Focal Segmental Glomerulosclerosis (FSGS)
Brief Description
The purpose of this Phase 2 adaptive study is to evaluate PF-06730512 following multiple intravenous infusions in adult patients with FSGS. The intention is to evaluate drug safety, as well as to obtain an early indication of efficacy (how well the drug works at improving Urine Protein to Creatinine Ratio, which is a marker of kidney damage).
Trial Physician / Study Coordinator
Isabelle Ayoub
EmailSite Name
The Ohio State University
Wexner Medical Center, 395 W 12th Avenue, Ground Floor, Columbus, OH 43210
Sponsor
Pfizer Inc.
Study Drug
PF-06730512
Estimated enrollment
44
Estimated end date
May, 2023
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
The PODO Trial for FSGS Patients
Trial To Evaluate PF-06730512 In Adults With Focal Segmental Glomerulosclerosis (FSGS)
Brief Description
The purpose of this Phase 2 adaptive study is to evaluate PF-06730512 following multiple intravenous infusions in adult patients with FSGS. The intention is to evaluate drug safety, as well as to obtain an early indication of efficacy (how well the drug works at improving Urine Protein to Creatinine Ratio, which is a marker of kidney damage).
Trial is for people with
Focal segmental glomerulosclerosis (FSGS)
Study Goal
To evaluate the safety, tolerability, and, possibly, efficacy of PF-06730512 in patients with FSGS.
What is involved for the Patient?
Patients will participate for about 8.5 months, and will receive the study drug by intravenous infusion every 2 weeks over a 12 week period.
About the drug or intervention
PF-06730512 works as an antagonist, meaning it possibly reduces a biologic activity that is associated with FSGS. PF-06730512 has been designed to affect the podocyte, which, when working properly, is associated with normal kidney function.