Podo Study For Focal Segmental Glomerulosclerosis (Fsgs)
Posted Date: Mar 30, 2021
- Investigator: Amit Govil
- Type of Study: Drug
The purpose of this research study is to learn about the effects, overall safety, how well the Intravenous study drug (PF-06730512) is tolerated, and to evaluate blood levels of the drug following intravenous administration every two weeks over 12 weeks. Intravenous administration means that the study drug is infused in one of your veins on your arm. PF-06730512 is an investigational drug. An investigational drug is one that is currently not approved for sale in the United States by the U.S. Food and Drug Administration (FDA) or any other country. The primary goal of this study is to obtain an early sign that the drug works in reducing the amout of protein that is excreted in your urine, thus this is an "open-label" trial, meaning that all subjects receive study drug, there is not control/placebo group. The treatment period is 12 week, followed by 4 visits over 9 weeks for follow-up.
Subjects Need A Confirmed Diagnosis Of Fsgs By Biopsy Within The Last 5 Years. Egfr Should Be >45, Urine Protein To Creatine Ratio (Upcr) Should Be > 1.5 G/G, And Some Prior Treatment Must Have Been Done, Even If You Became Intoerant Of It. Collapsing Fsgs Is Not Included, Nor Is This Study For Patients Who Have Received An Organ Transplant (Of Any Kind). Other Criteria Are Also Included.
Glomerulosclerosis, Proteinuria, Renal
For More Information:
Heather J Duncan