Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
The PODO Trial for People with FSGS
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 adults with FSGS. The intention is to evaluate study drug safety, as well as to obtain an early indication of effectiveness (how well the study drug works at improving Urine Protein to Creatinine Ratio, which is a marker of kidney damage).
Trial Physician / Study Coordinator
Heather Reich
EmailSite Name
Toronto General Hospital
8N-849, 200 Elizabeth St., Toronto, ON M5G 2C4
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 People with FSGS
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 adults with FSGS. The intention is to evaluate study drug safety, as well as to obtain an early indication of effectiveness (how well the study 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, pharmacokinetics and, efficacy of PF-06730512 in patients with FSGS.
What is involved for the Patient?
Patients will participate for about 11 months, and will receive the study drug by intravenous infusion every 2 weeks over a 24 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.