A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)

Study Overview
=================
Brief Summary
-----------------
This research study is designed to assess the safety and effectiveness of an experimental drug called PRT-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. PRT-201 is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF.

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

Conditions
-----------------
Chronic Kidney Disease

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of at least 18 years. Life expectancy of at least 6 months. Diagnosis of Chronic Kidney Disease (CKD). Planned creation of a new radiocephalic arteriovenous fistula (AVF)-revision of an existing AVF is not eligible. Ability to understand and comply with the requirements of the entire study and to communicate with the study team. Written informed consent using a document that has been approved by the Institutional Review Board (IRB). If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the screening visit (Visit 1) and be willing to use contraception from the time of the screening visit to 2 weeks following study drug administration. Acceptable methods of birth control include abstinence, barrier methods, hormones, or intra uterine device. Exclusion Criteria: 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 or squamous cell skin cancer, or any cancer in situ. Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study. Previous treatment with PRT 201. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within the previous 90 days prior to signing informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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<br>PRT-201 administered at the time of radiocephalic fistula creation | Drug: PRT-201<br> <br> * Other names: vonapanitase;|
| Placebo Comparator: Placebo<br>Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition to PRT-201 but lacks the active ingredient. | Drug: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to AVF Primary Unassisted Patency | Primary unassisted patency defined as the time from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency. | Days from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency, assessed up to 1 year | 
| Kaplan-Meier Estimate of Secondary AVF Patency | Kaplan-Meier Estimate of median time from AVF creation until AVF abandonment (secondary patency) | Median time from AVF creation until AVF abandonment (secondary patency), assessed up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AVF, vonapanitase, radiocephalic, arteriovenous fistula, hemodialysis, PRT-201, vascular access, kidney, renal, PATENCY-1