A Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01305824|
Recruitment Status : Completed
First Posted : March 1, 2011
Last Update Posted : April 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Drug: PRT-201 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||151 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
|Active Comparator: PRT 201 (10 micrograms)||
PRT-201 10 micrograms administered at the time of AVF creation.
|Placebo Comparator: Placebo||
Placebo administered at the time of AVF creation.
|Active Comparator: PRT-201 (30 micrograms)||
PRT-201 30 micrograms administered at the time of AVF creation.
- Primary AVF patency. [ Time Frame: 12 months after AVF creation ]
- Number of participants with adverse events as a measure of safety and tolerability of PRT-201. [ Time Frame: 12 months after AVF creation. ]
- Secondary Fistula Patency [ Time Frame: 12 months after AVF creation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305824
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