Currently Enrolling
Interventional

The PODO Trial for People with FSGS

Trial To Evaluate PF-06730512 In Adults With Focal Segmental Glomerulosclerosis (FSGS)

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 drug safety, as well as to obtain an early indication of effectiveness (how well the drug works at improving Urine Protein to Creatinine Ratio, which is a marker of kidney damage).

Currently Enrolling
Interventional

The PODO Trial for People with FSGS

Trial To Evaluate PF-06730512 In Adults With Focal Segmental Glomerulosclerosis (FSGS)

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 drug safety, as well as to obtain an early indication of effectiveness (how well the drug works at improving Urine Protein to Creatinine Ratio, which is a marker of kidney damage).

Eligibility Criteria
Patient Population

Focal segmental glomerulosclerosis (FSGS)

Age

18 — 26+

History of transplant allowed?

No

History of dialysis allowed?

No

eGFR

30 — > 60

UPCR

1.1 — 3.0 or Above

Permitted medication history

Ace Inhibitors/ARB, Prednisone (Steroids), Abatacept, Acthar, Cellcept (AKA Mycophenolate), Cytoxan (Cyclophosphamide), Prograf (AKA Tacrolimus), Rituximab (AKA Rituxan), Other, None

Patient should be

Treatment Resistant, Steroid Dependent, Neither of These

About the Drug
What is involved for the patient

Adults will participate for about 8.5 months, and will receive the study drug by intravenous infusion every 2 weeks over a 12 week period.

Sponsor

Pfizer Inc.

Target Enrollment

44

Estimated End Date

May, 2023

About the Trial
Study Drug

PF-06730512

Study Goal

To evaluate the safety, tolerability, and, possibly, effectiveness of PF-06730512 in people with FSGS.

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.

Birmingham, AL
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.

The Kidney Health Gateway is a website owned and operated by NephCure Kidney International. The purpose of this website is to help patients with rare forms of primary Nephrotic Syndrome get connected to expert care and cutting-edge treatment options. By answering a few questions about you or your loved one’s condition, we can provide you with a list of clinical trials and/or expert doctors in your area.

If you have additional questions, please visit NephCure.org or email Info@NephCure.org.

 

See other frequently asked questions