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Enrollment Closed
1

The PODO Trial

Trial To Evaluate PF-06730512 In Adults With Primary Focal Segmental Glomerulosclerosis

Brief Description

The purpose of this Phase 2 adaptive study is to evaluate PF-06730512 following multiple intravenous infusions in adult patients with primary FSGS. In addition, the intention is to obtain an early indication of efficacy (how well the drug works at improving Urine Protein to Creatinine Ratio).

Trial Physician / Study Coordinator

Michelle Hladunewich

Email Phone
Site Name

Sunnybrook Health Sciences Centre - Kidney Care Centre at the CNIB
1929 Bayview Avenue, Room 390, Toronto, ON M4G 3E8

Sponsor

Pfizer Inc.

Study Drug

PF-06730512

Estimated enrollment

44

Estimated end date

May, 2023

If there is not a site for a clinical trial nearby, you can ask the study team about the possibility of travel reimbursements (i.e., paying you back for your travel costs). Alternatively, you can ask about the possibility of participating from home.
Find other locations for this trial:
Enrollment Closed
1

The PODO Trial

Trial To Evaluate PF-06730512 In Adults With Primary Focal Segmental Glomerulosclerosis

Brief Description

The purpose of this Phase 2 adaptive study is to evaluate PF-06730512 following multiple intravenous infusions in adult patients with primary FSGS. In addition, the intention is to obtain an early indication of efficacy (how well the drug works at improving Urine Protein to Creatinine Ratio).

Trial is for people with

Primary focal segmental glomerulosclerosis (FSGS)

Study Goal

To evaluate the safety, tolerability, and possibily efficacy of PF-06730512 in patients with FSGS.

What is involved for the Patient?

Patients will participate for 13 weeks, receiving an intravenous infusion of the study drug weekly.

About the drug or intervention

PF-06730512 works as an antagonist, meaning it possibly reduces the biologic activity that is associated with FSGS.

Find other locations for this trial:
Toronto, ON, Canada
Frequently Asked Questions

Nephrotic Syndrome is not a disease itself, but rather a group of signs and symptoms that result from damage in the part of the kidney that filters blood (glomeruli).

Common symptoms include:

  • Foamy urine (called proteinuria) caused by protein “spilling” into the urine
  • Severe swelling in parts of the body, most noticeably around the eyes, hands, feet, and abdomen (called edema)
  • Weight gain due to a buildup of extra fluid
  • Fatigue
  • Loss of appetite
  • Low levels of protein in the blood (hypoalbuminemia)
  • Higher than normal fat and cholesterol levels in the blood (hyperlipidemia)

Nephrotic Syndrome can typically be diagnosed with a urine test.

Nephrotic Syndrome can be “primary” or “secondary” in nature.

Diseases that affect only the kidneys are called primary causes of Nephrotic Syndrome. Doctors often call these diseases “idiopathic,” which means that they arise from an unknown cause. Some of these diseases include:

  • Minimal Change Disease (MCD) – most common in children
  • Focal Segmental Glomerulosclerosis (FSGS)
  • Membranous Nephropathy (MN) – most common in adults
  • IgA Nephropathy (IgAN)

Secondary Nephrotic Syndrome is caused by an underlying, systemic condition like diabetes, lupus, HIV, and others.

Clinical studies are any studies that involve people. There are two main types: observational and interventional. In an observational trial, researchers track health outcomes over time in groups of participants to look for patterns that help us better understand a disease. In an interventional trial, participants receive specific interventions, which can include new treatments or behavorial changes (e.g., diet changes). To learn more about clinical research, please visit the NephCure website.

See other frequently asked questions