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Clinical Trial Details

Trial ID: L0208
Source ID: NCT01001351
Associated Drug: Prt-201
Title: A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease
Acronym: PRT-201-102
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease
Interventions: DRUG: PRT-201|DRUG: Placebo
Outcome Measures: Primary: To assess the safety of a single topical dose of PRT-201., Day of AVG creation and 4 weeks After surgery. | Secondary: Primary graft patency, 3, 6, 9 and 12 months after AVG creation.|Secondary graft patency., 3, 6, 9 and 12 months after AVG creation.
Sponsor/Collaborators: Sponsor: Proteon Therapeutics
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 89
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2009-09
Completion Date: 2012-11
Results First Posted:
Last Update Posted: 2015-04-30
Locations: Ladenheim Dialysis Access Center, Fresno, California, 93710, United States|California Institute of Renal Research, San Diego, California, 92123, United States|Washington Hospital/Medstar Research, Washington, District of Columbia, 20010, United States|Indiana/Ohio Heart, Fort Wayne, Indiana, 46804, United States|Indiana University/Purdue University, Indianapolis, Indiana, 46202, United States|University of Louisville, Louisville, Kentucky, 40202, United States|Vascular Specialty Center, Baton Rouge, Louisiana, 70809, United States|Brigham & Women's Hospital, Boston, Massachusetts, 02115, United States|University of Massachusetts, Worcester, Massachusetts, 01655, United States|Weill Cornell Medical College, New York, New York, 10065, United States|Duke University Medical Center, Durham, North Carolina, 27710, United States|University of Cincinnati, Cincinnati, Ohio, 45267, United States|Greenville Memorial Hospital, Greenville, South Carolina, 29615, United States|The Methodist Hospital, Houston, Texas, 77030, United States|Peripheral Vascular Associates, San Antonio, Texas, 78205, United States|Sentara Vascular Specialists, Norfolk, Virginia, 23507, United States
URL: https://clinicaltrials.gov/show/NCT01001351