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A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease (PRT-201-102)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Proteon Therapeutics
ClinicalTrials.gov Identifier:
NCT01001351
First received: October 22, 2009
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
 Drug: PRT-201
Drug: Placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Graft Creation in Patients With Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Proteon Therapeutics:

Primary Outcome Measures:
  • To assess the safety of a single topical dose of PRT-201. [ Time Frame: Day of AVG creation and 4 weeks After surgery. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Primary graft patency [ Time Frame: 3, 6, 9 and 12 months after AVG creation. ] [ Designated as safety issue: Yes ]
  • Secondary graft patency. [ Time Frame: 3, 6, 9 and 12 months after AVG creation. ] [ Designated as safety issue: Yes ]

Enrollment: 89
Study Start Date: September 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Applied topically during surgery
Experimental: PRT-201 Drug: PRT-201
Applied topically during surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001351

Locations
United States, California
Ladenheim Dialysis Access Center
Fresno, California, United States, 93710
California Institute of Renal Research
San Diego, California, United States, 92123
United States, District of Columbia
Washington Hospital/Medstar Research
Washington, District of Columbia, United States, 20010
United States, Indiana
Indiana/Ohio Heart
Fort Wayne, Indiana, United States, 46804
Indiana University/Purdue University
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Vascular Specialty Center
Baton Rouge, Louisiana, United States, 70809
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
University of Massachusetts
Worcester, Massachusetts, United States, 01655
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
United States, South Carolina
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29615
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
Peripheral Vascular Associates
San Antonio, Texas, United States, 78205
United States, Virginia
Sentara Vascular Specialists
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Proteon Therapeutics
Investigators
Study Director: Marco Wong, MD, PhD Proteon Therapeutics Inc
  More Information

No publications provided

Responsible Party: Proteon Therapeutics
ClinicalTrials.gov Identifier: NCT01001351     History of Changes
Other Study ID Numbers: PRT-201-102
Study First Received: October 22, 2009
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Proteon Therapeutics:
Chronic Kidney Disease
Arteriovenous Grafts (AVG)
Hemodialysis
Vascular Access
 Dialysis
Graft
Access

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 19, 2013