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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Proteon Therapeutics
ClinicalTrials.gov Identifier:
NCT00679991
First received: May 15, 2008
Last updated: November 10, 2011
Last verified: November 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Proteon Therapeutics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis. [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 66
Study Start Date: November 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679991

Locations
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
  More Information

No publications provided by Proteon Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Proteon Therapeutics
ClinicalTrials.gov Identifier: NCT00679991     History of Changes
Other Study ID Numbers: PRT-201-101
Study First Received: May 15, 2008
Last Updated: November 10, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 19, 2014