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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Drug: PRT-201
* Drug: Placebo
* Drug: PRT-201


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of at least 18 years. Life expectancy of at least 6 months. Chronic kidney disease on hemodialysis, or with anticipated start of hemodialysis within 6 months. Planned creation of a new radiocephalic or brachiocephalic AVF. Revisions of an existing AVF and transposed AVF are not acceptable. Exclusion Criteria: History or presence of an arterial aneurysm. 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. 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. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PRT 201 (10 micrograms)<br> | Drug: PRT-201<br>* PRT-201 10 micrograms administered at the time of AVF creation.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo administered at the time of AVF creation.<br>|
| Active Comparator: PRT-201 (30 micrograms)<br> | Drug: PRT-201<br>* PRT-201 30 micrograms administered at the time of AVF creation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Fistula Patency |  | 12 months after AVF creation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fistula, AVF, kidney, renal, arteriovenous fistula, hemodialysis, vascular access, dialysis, PRT-201, vonapanitase