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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01001351

Acronym

PRT-201-102

Enrollment

Registered

2009-10-26

Start date

2009-09-30

Completion date

2012-11-30

Last updated

2015-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease, Arteriovenous Grafts (AVG), Hemodialysis, Vascular Access, Dialysis, Graft, Access, vonapanitase, kidney, renal

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.

Interventions

DRUGPRT-201

Applied topically during surgery.

DRUGPlacebo

Applied topically during surgery

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age of at least 18 years. 2. Chronic kidney disease with anticipated start of hemodialysis within 3 months or current hemodialysis dependence. 3. Planned creation of a new upper extremity AVG or jump graft

Exclusion criteria

1. Patients for whom this is the only potential site for an upper extremity vascular access. 2. 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. 3. 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. 4. History or presence of an arterial aneurysm. 5. Previous treatment with PRT-201.

Design outcomes

Primary

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

Secondary

Measure	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026