A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease
| Status: | Archived |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | September 2009 |
| End Date: | September 2011 |
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.
We found this trial at
9
sites
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University of Cincinnati Medical Center Opening in 1823 as the country
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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