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A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease (PRT-201-102)

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ClinicalTrials.gov Identifier: NCT01001351
Recruitment Status : Completed
First Posted : October 26, 2009
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):
Proteon Therapeutics

October 22, 2009
October 26, 2009
April 30, 2015
September 2009
November 2012   (Final data collection date for primary outcome measure)
To assess the safety of a single topical dose of PRT-201. [ Time Frame: Day of AVG creation and 4 weeks After surgery. ]
Same as current
Complete list of historical versions of study NCT01001351 on ClinicalTrials.gov Archive Site
  • Primary graft patency [ Time Frame: 3, 6, 9 and 12 months after AVG creation. ]
  • Secondary graft patency. [ Time Frame: 3, 6, 9 and 12 months after AVG creation. ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Chronic Kidney Disease
  • Drug: PRT-201
    Applied topically during surgery.
  • Drug: Placebo
    Applied topically during surgery
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PRT-201
    Intervention: Drug: PRT-201
Dwivedi AJ, Roy-Chaudhury P, Peden EK, Browne BJ, Ladenheim ED, Scavo VA, Gustafson PN, Wong MD, Magill M, Lindow F, Blair AT, Jaff MR, Franano FN, Burke SK. Application of human type I pancreatic elastase (PRT-201) to the venous anastomosis of arteriovenous grafts in patients with chronic kidney disease. J Vasc Access. 2014 Sep-Oct;15(5):376-84. doi: 10.5301/jva.5000235. Epub 2014 May 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
November 2012
November 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01001351
PRT-201-102
Yes
Not Provided
Not Provided
Proteon Therapeutics
Proteon Therapeutics
Not Provided
Study Director: Marco Wong, MD, PhD Proteon Therapeutics, Inc
Proteon Therapeutics
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP