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

Phase 1

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Placebo; Drug: PRT-201

• Registration Number: NCT01001351
• Lead Sponsor: Proteon Therapeutics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-22
• Study First Submitted QC: 2009-10-23
• Study First Posted: 2009-10-26
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Disposition First Submitted: 2014-04-02
• Disposition First Submitted QC: 2014-04-02
• Disposition First Posted: 2014-04-30
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

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

Exclusion Criteria

1. Patients for whom this is the only potential site for an upper extremity vascular access.
2. 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.
3. 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.
4. History or presence of an arterial aneurysm.
5. Previous treatment with PRT-201.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
PRT-201	PRT-201	-

Primary Outcome Measures

Name	Time	Method
To assess the safety of a single topical dose of PRT-201.	Day of AVG creation and 4 weeks After surgery.

Secondary Outcome Measures

Name	Time	Method
Primary graft patency	3, 6, 9 and 12 months after AVG creation.
Secondary graft patency.	3, 6, 9 and 12 months after AVG creation.

Trial Locations

Locations (16)

Ladenheim Dialysis Access Center; 🇺🇸 Fresno, California, United States

California Institute of Renal Research; 🇺🇸 San Diego, California, United States

Washington Hospital/Medstar Research; 🇺🇸 Washington, 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

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