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Clinical Trial Details

Trial ID: L0251
Source ID: NCT01305824
Associated Drug: Prt-201
Title: A Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease
Interventions: DRUG: PRT-201|DRUG: Placebo|DRUG: PRT-201
Outcome Measures: Primary: Primary AVF patency., 12 months after AVF creation|Number of participants with adverse events as a measure of safety and tolerability of PRT-201., 12 months after AVF creation. | Secondary: Secondary Fistula Patency, 12 months after AVF creation
Sponsor/Collaborators: Sponsor: Proteon Therapeutics
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 151
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2011-03
Completion Date: 2012-11
Results First Posted:
Last Update Posted: 2015-04-30
Locations: California Institute of Renal Research, San Diego, California, 92123, United States|Kaiser Permanente, San Diego, California, United States|UCSF, San Francisco, California, United States|Rush Medical Center, Chicago, Illinois, United States|Renal Care Associates, Peoria, Illinois, United States|Indiana Ohio Heart, Fort Wayne, Indiana, United States|Indiana University, Indianapolis, Indiana, 46202, United States|University of Iowa, Iowa City, Iowa, 52242, United States|University of Louisville, Louisville, Kentucky, United States|Vascular Specialty Center, Baton Rouge, Louisiana, United States|Beth Israel Deconness Hospital, Boston, Massachusetts, United States|Brigham and Women's Hospital, Boston, Massachusetts, United States|UMASS Medical Center, Worcester, Massachusetts, United States|St Clair Specialty Physicians, Detroit, Michigan, United States|Thoracic & Cardiovascular Healthcare Foundation, Lansing, Michigan, United States|Montefiore Medical Center, Bronx, New York, United States|Weill Cornell Medical College, New York, New York, 10065, United States|Duke University Medical Center, Durham, North Carolina, 27710, United States|Legacy Oregon Surgical, Portland, Oregon, United States|Lehigh Valley Hospital, Allentown, Pennsylvania, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States|The Methodist Hospital, Houston, Texas, 77030, United States|Sentara Medical Group, Norfolk, Virginia, 23507, United States
URL: https://clinicaltrials.gov/show/NCT01305824

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress