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NCT Number: NCT01001351

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

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ladenheim Dialysis Access Center, Fresno, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRT-201

Drug

Applied topically during surgery.

Placebo

Drug

Applied topically during surgery

Primary outcomes

  1. To assess the safety of a single topical dose of PRT-201.

    Time frame: Day of AVG creation and 4 weeks After surgery.

Secondary outcomes

  1. Primary graft patency

    Time frame: 3, 6, 9 and 12 months after AVG creation.

  2. Secondary graft patency.

    Time frame: 3, 6, 9 and 12 months after AVG creation.

Sponsors and collaborators

Lead sponsor

Proteon Therapeutics

Industry

Registry information

Official study 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

Acronym: PRT-201-102

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 26, 2009
Registry last updated
Apr 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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