A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
PRT-201 is a recombinant human type-I pancreatic elastase intended for local, long-lasting dilation of the AVG venous anastomosis and outflow vein. The goal of the treatment is to improve primary patency and long-term survival of AVGs and thereby provide patients with chronic kidney disease (CKD) a reliable and durable vascular access site for hemodialysis. Recent data indicate that up to three quarters of patients have loss of graft patency at one year, indicating a substantial need for new therapies. This clinical trial will explore the safety and dilatory effect of topically administered PRT-201 on the outflow vein of a newly placed upper extremity AVG.

Official Title
-----------------
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Graft 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. Chronic kidney disease with anticipated start of hemodialysis within 3 months or current hemodialysis dependence. Planned creation of a new upper extremity AVG or jump graft Exclusion Criteria: Patients for whom this is the only potential site for an upper extremity vascular access. Creation of a new AVG or jump graft in an upper extremity previously treated with an investigational gene or cell based therapy, or locally with an investigational pharmacological agent. On physical examination or by other means, suspected proximal vein stenosis, occlusion, lack of continuity with the subclavian vein, central venous stenosis or central venous occlusion. History or presence of an arterial aneurysm. Previous treatment with PRT-201.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Applied topically during surgery<br>|
| Experimental: PRT-201<br> | Drug: PRT-201<br>* Applied topically during surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of a single topical dose of PRT-201. |  | Day of AVG creation and 4 weeks After surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary graft patency |  | 3, 6, 9 and 12 months after AVG creation. | 
| Secondary graft patency. |  | 3, 6, 9 and 12 months after AVG creation. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney Disease, Arteriovenous Grafts (AVG), Hemodialysis, Vascular Access, Dialysis, Graft, Access, vonapanitase, kidney, renal