A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Chronic Kidney Disease

In brief

PRT-201 is a recombinant human type-I pancreatic elastase intended for local, long-lasting dilation of the AVG venous anastomosis and outflow vein. The goal of the treatment is to improve primary patency and long-term survival of AVGs and thereby provide patients with chronic kidney disease (CKD) a reliable and durable vascular access site for hemodialysis. Recent data indicate that up to three quarters of patients have loss of graft patency at one year, indicating a substantial need for new therapies. This clinical trial will explore the safety and dilatory effect of topically administered PRT-201 on the outflow vein of a newly placed upper extremity AVG.

Key facts

Study ID

NCT01001351

Run by

Proteon Therapeutics

People needed

89

Starts

2009-09-01

Expected to finish

2012-11-01

Last updated by the study team

2015-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age of at least 18 years.
• Chronic kidney disease with anticipated start of hemodialysis within 3 months or current hemodialysis dependence.
• Planned creation of a new upper extremity AVG or "jump" graft

You may not qualify if…

• Patients for whom this is the only potential site for an upper extremity vascular access.
• Creation of a new AVG or "jump" graft in an upper extremity previously treated with an investigational gene or cell based therapy, or locally with an investigational pharmacological agent.
• On physical examination or by other means, suspected proximal vein stenosis, occlusion, lack of continuity with the subclavian vein, central venous stenosis or central venous occlusion.
• History or presence of an arterial aneurysm.
• Previous treatment with PRT-201.

Where it is running

• Ladenheim Dialysis Access Center — Fresno, California, United States
• California Institute of Renal Research — San Diego, California, United States
• Washington Hospital/Medstar Research — Washington D.C., District of Columbia, United States
• Indiana/Ohio Heart — Fort Wayne, Indiana, United States
• Indiana University/Purdue University — Indianapolis, Indiana, United States
• University of Louisville — Louisville, Kentucky, United States
• Vascular Specialty Center — Baton Rouge, Louisiana, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• University of Massachusetts — Worcester, Massachusetts, United States
• Weill Cornell Medical College — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Greenville Memorial Hospital — Greenville, South Carolina, United States
• The Methodist Hospital — Houston, Texas, United States
• Peripheral Vascular Associates — San Antonio, Texas, United States
• Sentara Vascular Specialists — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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