A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00679991
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : April 30, 2015
Information provided by (Responsible Party):
Proteon Therapeutics

Brief Summary:
PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel. The purpose of this study is to determine if PRT-201, when applied to a limited segment of blood vessel immediately after surgery to create an arteriovenous fistula (AVF), is safe, dilates the blood vessel, and increases blood flow through the AVF.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1-2, Multi-Center, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Study Start Date : November 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: PRT-201 Drug: PRT-201
Applied topically to AVF during surgery

Drug: PRT-201
Dose escalation study. Drug/placebo administered at the time of fistula creation

Placebo Comparator: 2 Drug: PRT-201
Dose escalation study. Drug/placebo administered at the time of fistula creation

Primary Outcome Measures :
  1. To assess the safety of a single topical dose of PRT-201. To assess the effect on the diameter of and blood flow through the AVF outflow vein. [ Time Frame: 2 & 6 weeks after AVF creation ]

Secondary Outcome Measures :
  1. The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis. [ Time Frame: 3, 6, 9, and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age of at least 18 years.
  • Chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence.
  • Planned creation of a new AVF.

Exclusion Criteria:

  • Patients for whom this is the only potential site for an AVF.
  • By physical examination, absence of radial or ulnar artery flow or non-patent palmer arch.
  • Treatment with any investigational agent within the previous 30 days or investigational antibody therapy within 90 days of signing informed consent.
  • Pregnancy, lactation or plans to become pregnant during the course of the study.

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 identifier (NCT number): NCT00679991

United States, Indiana
Clarian Health Partners/Indiana University/Purdue University
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Western New England Renal & Transplant Associates
Springfield, Massachusetts, United States, 01104
United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63110
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 Medical Center
Cincinnati, Ohio, United States, 45267
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
United States, Virginia
Sentara Medical Group
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Proteon Therapeutics

Publications of Results:
Responsible Party: Proteon Therapeutics Identifier: NCT00679991     History of Changes
Other Study ID Numbers: PRT-201-101
First Posted: May 19, 2008    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: April 2015

Keywords provided by Proteon Therapeutics:
arteriovenous fistula
vascular access
PRT 201
dose escalation

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Arteriovenous Fistula
Urologic Diseases
Renal Insufficiency
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical