Trial record 18 of 56 for:
A Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
This study has been completed.
Information provided by (Responsible Party):
First received: February 16, 2011
Last updated: May 15, 2013
Last verified: May 2013
The purpose of this study is to determine if PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous fistula is safe and improves the patency of your fistula. PRT-201 is a protein that has been shown to help keep vessels open ("patent") when applied to the outside surface of the blood vessels (arteries and veins) in AVF patients in a previous study.
Chronic Kidney Disease
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Primary Outcome Measures:
- Primary AVF patency. [ Time Frame: 12 months after AVF creation ] [ Designated as safety issue: Yes ]
- Number of participants with adverse events as a measure of safety and tolerability of PRT-201. [ Time Frame: 12 months after AVF creation. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Secondary Fistula Patency [ Time Frame: 12 months after AVF creation ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2012 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Age of at least 18 years.
- Life expectancy of at least 6 months.
- Chronic kidney disease on hemodialysis, or with anticipated start of hemodialysis within 6 months.
- Planned creation of a new radiocephalic or brachiocephalic AVF. Revisions of an existing AVF and transposed AVF are not acceptable.
- History or presence of an arterial aneurysm.
- Malignancy or treatment for malignancy within the previous 12 months with the exception of the following cancers if they have been resected: localized basal cell cancer, squamous cell skin cancer, or any cancer in situ.
- Hepatic dysfunction defined as bilirubin, ALT [SGPT] or AST [SGOT] >2.5 times the upper limit of normal, decompensated cirrhosis, ascites, or known esophageal or gastric varices.
- Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305824
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 16, 2011
||May 15, 2013
||United States: Food and Drug Administration
Keywords provided by Proteon Therapeutics:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 10, 2013
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Pathological Conditions, Anatomical