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

Proteon Therapeutics151 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

151

Conditions

Chronic Kidney Disease

Interventions

PRT-201DRUG

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

PlaceboDRUG

Placebo administered at the time of AVF creation.

PRT-201DRUG

PRT-201 30 micrograms administered at the time of AVF creation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (23)

California Institute of Renal Research

San Diego, California, United States

Outcomes

Primary Outcomes

Primary AVF patency.

Time frame: 12 months after AVF creation

Number of participants with adverse events as a measure of safety and tolerability of PRT-201.

Time frame: 12 months after AVF creation.

Secondary Outcomes

Secondary Fistula Patency

Time frame: 12 months after AVF creation

Data from ClinicalTrials.gov

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