Status:
COMPLETED
A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients
Lead Sponsor:
Proteon Therapeutics
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00679991
Start Date
November 1 2008
End Date
July 1 2011
Last Update
April 30 2015
Active Locations (11)
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1
Clarian Health Partners/Indiana University/Purdue University
Indianapolis, Indiana, United States, 46202
2
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
3
Maine Medical Center
Portland, Maine, United States, 04102
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115