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

April 8, 2015 updated by: Proteon Therapeutics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Primary graft patency
Time Frame: 3, 6, 9 and 12 months after AVG creation.
3, 6, 9 and 12 months after AVG creation.
Secondary graft patency.
Time Frame: 3, 6, 9 and 12 months after AVG creation.
3, 6, 9 and 12 months after AVG creation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Proteon Therapeutics

Investigators

  • Study Director: Marco Wong, MD, PhD, Proteon Therapeutics, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

October 22, 2009

First Submitted That Met QC Criteria

October 23, 2009

First Posted (Estimate)

October 26, 2009

Study Record Updates

Last Update Posted (Estimate)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRT-201-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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