A Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

• Sponsor: Proteon Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01305824
• Collaborator: (none)
• Enrollment: 151
• Locations: 23
• Arms: 3
• Duration (Months): 20.1
• Patients Per Site: 6.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous fistula is safe and improves the patency of your fistula. PRT-201 is a protein that has been shown to help keep vessels open ("patent") when applied to the outside surface of the blood vessels (arteries and veins) in AVF patients in a previous study.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 151 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PRT 201 (10 micrograms)	Drug: PRT-201; PRT-201 10 micrograms administered at the time of AVF creation.
Placebo Comparator: Placebo	Drug: Placebo; Placebo administered at the time of AVF creation.
Active Comparator: PRT-201 (30 micrograms)	Drug: PRT-201; PRT-201 30 micrograms administered at the time of AVF creation.

Outcome Measures

Primary Outcome Measures

1. Primary AVF patency. [12 months after AVF creation]

2. Number of participants with adverse events as a measure of safety and tolerability of PRT-201. [12 months after AVF creation.]

Secondary Outcome Measures

1. Secondary Fistula Patency [12 months after AVF creation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age of at least 18 years.

2. Life expectancy of at least 6 months.

3. Chronic kidney disease on hemodialysis, or with anticipated start of hemodialysis within 6 months.

4. Planned creation of a new radiocephalic or brachiocephalic AVF. Revisions of an existing AVF and transposed AVF are not acceptable.

Exclusion Criteria:

1. History or presence of an arterial aneurysm.

2. Malignancy or treatment for malignancy within the previous 12 months with the exception of the following cancers if they have been resected: localized basal cell cancer, squamous cell skin cancer, or any cancer in situ.

3. Hepatic dysfunction defined as bilirubin, ALT [SGPT] or AST [SGOT] >2.5 times the upper limit of normal, decompensated cirrhosis, ascites, or known esophageal or gastric varices.

4. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Institute of Renal Research	San Diego	California	United States	92123
2	Kaiser Permanente	San Diego	California	United States
3	UCSF	San Francisco	California	United States
4	Rush Medical Center	Chicago	Illinois	United States
5	Renal Care Associates	Peoria	Illinois	United States
6	Indiana Ohio Heart	Fort Wayne	Indiana	United States
7	Indiana University	Indianapolis	Indiana	United States	46202
8	University of Iowa	Iowa City	Iowa	United States	52242
9	University of Louisville	Louisville	Kentucky	United States
10	Vascular Specialty Center	Baton Rouge	Louisiana	United States
11	Beth Israel Deconness Hospital	Boston	Massachusetts	United States
12	Brigham and Women's Hospital	Boston	Massachusetts	United States
13	UMASS Medical Center	Worcester	Massachusetts	United States
14	St Clair Specialty Physicians	Detroit	Michigan	United States
15	Thoracic & Cardiovascular Healthcare Foundation	Lansing	Michigan	United States
16	Montefiore Medical Center	Bronx	New York	United States
17	Weill Cornell Medical College	New York	New York	United States	10065
18	Duke University Medical Center	Durham	North Carolina	United States	27710
19	Legacy Oregon Surgical	Portland	Oregon	United States
20	Lehigh Valley Hospital	Allentown	Pennsylvania	United States
21	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
22	The Methodist Hospital	Houston	Texas	United States	77030
23	Sentara Medical Group	Norfolk	Virginia	United States	23507

Sponsors and Collaborators

• Proteon Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Proteon Therapeutics
• ClinicalTrials.gov Identifier: NCT01305824
• Other Study ID Numbers: PRT-201-201
• First Posted: Mar 1, 2011
• Last Update Posted: Apr 30, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Proteon Therapeutics: arteriovenous fistula; AVF; hemodialysis; vascular access; dialysis; fistula; PRT-201; vonapanitase; kidney; renal
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Arteriovenous Fistula; Fistula

Study Results

No Results Posted as of Apr 30, 2015