A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Proteon Therapeutics
ClinicalTrials.gov Identifier:
NCT00679991
First received: May 15, 2008
Last updated: November 10, 2011
Last verified: November 2011

May 15, 2008
November 10, 2011
November 2008
July 2011   (final data collection date for primary outcome measure)
To assess the safety of a single topical dose of PRT-201. To assess the effect on the diameter of and blood flow through the AVF outflow vein. [ Time Frame: 2 & 6 weeks after AVF creation ] [ Designated as safety issue: Yes ]
To assess the safety of a single topical dose of PRT-201. To assess the effect on the diameter of and blood flow through the AVF outflow vein. [ Time Frame: 2 & 4 weeks after AVF creation ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00679991 on ClinicalTrials.gov Archive Site
The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis. [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients
A Phase 1-2, Multi-Center, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel. The purpose of this study is to determine if PRT-201, when applied to a limited segment of blood vessel immediately after surgery to create an arteriovenous fistula (AVF), is safe, dilates the blood vessel, and increases blood flow through the AVF.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Kidney Disease
  • Drug: PRT-201
    Applied topically to AVF during surgery
  • Drug: PRT-201
    Dose escalation study. Drug/placebo administered at the time of fistula creation
  • Active Comparator: PRT-201
    Interventions:
    • Drug: PRT-201
    • Drug: PRT-201
  • Placebo Comparator: 2
    Intervention: Drug: PRT-201
Peden EK, Leeser DB, Dixon BS, El-Khatib MT, Roy-Chaudhury P, Lawson JH, Menard MT, Dember LM, Glickman MH, Gustafson PN, Blair AT, Magill M, Franano FN, Burke SK. A multi-center, dose-escalation study of human type I pancreatic elastase (PRT-201) administered after arteriovenous fistula creation. J Vasc Access. 2013 Apr-Jun;14(2):143-51. doi: 10.5301/jva.5000125. Epub 2012 Nov 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age of at least 18 years.
  • Chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence.
  • Planned creation of a new AVF.

Exclusion Criteria:

  • Patients for whom this is the only potential site for an AVF.
  • By physical examination, absence of radial or ulnar artery flow or non-patent palmer arch.
  • Treatment with any investigational agent within the previous 30 days or investigational antibody therapy within 90 days of signing informed consent.
  • Pregnancy, lactation or plans to become pregnant during the course of the study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00679991
PRT-201-101
Yes
Proteon Therapeutics
Proteon Therapeutics
Not Provided
Not Provided
Proteon Therapeutics
November 2011

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