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

Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01305824

Enrollment

151

Registered

2011-03-01

Start date

2011-03-31

Completion date

2012-11-30

Last updated

2015-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

arteriovenous fistula, AVF, hemodialysis, vascular access, dialysis, fistula, PRT-201, vonapanitase, kidney, renal

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.

Interventions

DRUGPRT-201

PRT-201 10 micrograms administered at the time of AVF creation.

DRUGPlacebo

Placebo administered at the time of AVF creation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Primary AVF patency.	12 months after AVF creation
Number of participants with adverse events as a measure of safety and tolerability of PRT-201.	12 months after AVF creation.

Secondary

Measure	Time frame
Secondary Fistula Patency	12 months after AVF creation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026