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

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ClinicalTrials.gov Identifier: NCT01001351
Recruitment Status : Completed
First Posted : October 26, 2009
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: PRT-201 Drug: Placebo Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Study Start Date : September 2009
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Applied topically during surgery
Experimental: PRT-201 Drug: PRT-201
Applied topically during surgery.


Outcome Measures

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

Secondary Outcome Measures :
  1. Primary graft patency [ Time Frame: 3, 6, 9 and 12 months after AVG creation. ]
  2. Secondary graft patency. [ Time Frame: 3, 6, 9 and 12 months after AVG creation. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Proteon Therapeutics
ClinicalTrials.gov Identifier: NCT01001351     History of Changes
Other Study ID Numbers: PRT-201-102
First Posted: October 26, 2009    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: April 2015

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

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