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

Sponsor

Proteon Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00679991

Collaborator

(none)

Enrollment

Locations

Arms

31.9

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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 Drug: PRT-201	Phase 1/Phase 2

Study Design

Study Type:

Interventional

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 :

Nov 1, 2008

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

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

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

Outcome Measures

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. [2 & 6 weeks after AVF creation]

Secondary Outcome Measures

The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis. [3, 6, 9, and 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Clarian Health Partners/Indiana University/Purdue University	Indianapolis	Indiana	United States	46202
2	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
3	Maine Medical Center	Portland	Maine	United States	04102
4	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
5	Western New England Renal & Transplant Associates	Springfield	Massachusetts	United States	01104
6	Washington University in St. Louis	St. Louis	Missouri	United States	63110
7	Weill Cornell Medical College	New York	New York	United States	10065
8	Duke University Medical Center	Durham	North Carolina	United States	27710
9	University of Cincinnati Medical Center	Cincinnati	Ohio	United States	45267
10	The Methodist Hospital	Houston	Texas	United States	77030
11	Sentara Medical Group	Norfolk	Virginia	United States	23507