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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PRT-201

Group Type ACTIVE_COMPARATOR

PRT-201

Intervention Type DRUG

Applied topically to AVF during surgery

PRT-201

Intervention Type DRUG

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

2

Group Type PLACEBO_COMPARATOR

PRT-201

Intervention Type DRUG

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

Interventions

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PRT-201

Applied topically to AVF during surgery

Intervention Type DRUG

PRT-201

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No