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

Proteon Therapeutics66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Kidney Disease

Interventions

PRT-201DRUG

Applied topically to AVF during surgery

PRT-201DRUG

Dose escalation study. Drug/placebo administered at the time of fistula creation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

Clarian Health Partners/Indiana University/Purdue University

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Maine Medical Center

Portland, Maine, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 & 6 weeks after AVF creation

Secondary Outcomes

The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis.

Time frame: 3, 6, 9, and 12 months

Data from ClinicalTrials.gov

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