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

Sponsor

Proteon Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT01001351

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

5.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease	Drug: PRT-201 Drug: Placebo	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

89 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Drug: Placebo

Applied topically during surgery

Experimental: PRT-201

Drug: PRT-201

Applied topically during surgery.

Outcome Measures

Primary Outcome Measures

To assess the safety of a single topical dose of PRT-201. [Day of AVG creation and 4 weeks After surgery.]

Secondary Outcome Measures

Primary graft patency [3, 6, 9 and 12 months after AVG creation.]
Secondary graft patency. [3, 6, 9 and 12 months after AVG creation.]

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 3 months or current hemodialysis dependence.
Planned creation of a new upper extremity AVG or "jump" graft

Exclusion Criteria:

Patients for whom this is the only potential site for an upper extremity vascular access.
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.
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.
History or presence of an arterial aneurysm.
Previous treatment with PRT-201.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ladenheim Dialysis Access Center	Fresno	California	United States	93710
2	California Institute of Renal Research	San Diego	California	United States	92123
3	Washington Hospital/Medstar Research	Washington	District of Columbia	United States	20010
4	Indiana/Ohio Heart	Fort Wayne	Indiana	United States	46804
5	Indiana University/Purdue University	Indianapolis	Indiana	United States	46202
6	University of Louisville	Louisville	Kentucky	United States	40202
7	Vascular Specialty Center	Baton Rouge	Louisiana	United States	70809
8	Brigham & Women's Hospital	Boston	Massachusetts	United States	02115
9	University of Massachusetts	Worcester	Massachusetts	United States	01655
10	Weill Cornell Medical College	New York	New York	United States	10065
11	Duke University Medical Center	Durham	North Carolina	United States	27710
12	University of Cincinnati	Cincinnati	Ohio	United States	45267
13	Greenville Memorial Hospital	Greenville	South Carolina	United States	29615
14	The Methodist Hospital	Houston	Texas	United States	77030
15	Peripheral Vascular Associates	San Antonio	Texas	United States	78205
16	Sentara Vascular Specialists	Norfolk	Virginia	United States	23507