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NCT00679991 Clinical Trial

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

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00679991
Other study ID # PRT-201-101
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received May 15, 2008
Last updated April 8, 2015
Start date November 2008
Est. completion date July 2011

Study information
Verified date April 2015
Source Proteon Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PRT-201
Applied topically to AVF during surgery
• PRT-201
Dose escalation study. Drug/placebo administered at the time of fistula creation

Locations
Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts
United States University of Cincinnati Medical Center Cincinnati Ohio
United States Duke University Medical Center Durham North Carolina
United States The Methodist Hospital Houston Texas
United States Clarian Health Partners/Indiana University/Purdue University Indianapolis Indiana
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States Weill Cornell Medical College New York New York
United States Sentara Medical Group Norfolk Virginia
United States Maine Medical Center Portland Maine
United States Western New England Renal & Transplant Associates Springfield Massachusetts
United States Washington University in St. Louis St. Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Proteon Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (1)

Peden EK, Leeser DB, Dixon BS, El-Khatib MT, Roy-Chaudhury P, Lawson JH, Menard MT, Dember LM, Glickman MH, Gustafson PN, Blair AT, Magill M, Franano FN, Burke SK. A multi-center, dose-escalation study of human type I pancreatic elastase (PRT-201) adminis — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 2 & 6 weeks after AVF creation Yes
Secondary The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis. 3, 6, 9, and 12 months Yes
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