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Clinical Trial Details

Trial ID: L0246
Source ID: NCT02414841
Associated Drug: Vonapanitase
Title: A Study of Vonapanitase (PRT-201) Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-2)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02414841/results
Conditions: Chronic Kidney Disease
Interventions: DRUG: Vonapanitase|DRUG: Placebo
Outcome Measures: Primary: Kaplan-Meier Estimate of Secondary AVF Patency, Kaplan-Meier estimate of median time from AVF creation until AVF abandonment (secondary patency), Median time from AVF creation to AVF abandonment (secondary patency), assessed up to 1 year.|Number of Participants With AVF Use for Hemodialysis, AVF use for hemodialysis is defined as the ability of the study AVF to be successfully cannulated and used for hemodialysis for a minimum of 90 days or at least 30 days prior to a patient's last visit, if hemodialysis has not been initiated at least 90 days prior to the patient's last visit. If AVF use is not defined as above, non-use of the AVF for hemodialysis is defined as an abandoned fistula prior to use; or if hemodialysis is recorded on 2 consecutive visits and there is no cannulation date or duration of use is less than 90 days. The patients who are not categorized as having use or non-use of the AVF have insufficient data to determine AVF use for hemodialysis and will be categorized as having indeterminate use., Assessed at up to 12 Months |
Sponsor/Collaborators: Sponsor: Proteon Therapeutics
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 696
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-08
Completion Date: 2019-05-01
Results First Posted: 2019-08-13
Last Update Posted: 2019-08-13
Locations: University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States|AKDHC Medical Research Services, LLC, Phoenix, Arizona, 85012, United States|Banner University Medical Center Tucson, Tucson, Arizona, 85724, United States|AKDHC Medical Research Services, LLc, Tucson, Arizona, 85745, United States|VA Loma Linda Healthcare System, Loma Linda, California, 92357, United States|VA Medical Center Long Beach, Long Beach, California, 90822, United States|Keck University Hospital at USC, Los Angeles, California, 90033, United States|Kaiser Permanente, San Diego, California, 92120, United States|California Institute of Renal Research, San Diego, California, 92123, United States|Kaiser Permanente Northern California, San Francisco, California, 94118, United States|University of Chicago, Chicago, Illinois, 60637, United States|RenalCare Associates, S.C., Peoria, Illinois, 61603, United States|Lutheran Hospital Network of Indiana, Fort Wayne, Indiana, 46804, United States|The University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242, United States|University of Louisville, Louisville, Kentucky, 40202, United States|Tulane University, New Orleans, Louisiana, 70112, United States|Maine Medical Center, Portland, Maine, 04102, United States|Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States|University of Massachusetts Medical Center, Worcester, Massachusetts, 01655, United States|VA Ann Arbor Healthcare System, Ann Arbor, Michigan, 48105, United States|Henry Ford Hospital, Detroit, Michigan, 48202, United States|Greenwood Leflore Hospital, Greenwood, Mississippi, 38930, United States|Saint Luke's Hospital, Kansas City, Missouri, 64111, United States|New York Presbyterian Hospital-Weill Cornell Medical Center, New York, New York, 10065, United States|University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, United States|Wake Forest, Winston-Salem, North Carolina, 27157, United States|Cleveland Clinic, Cleveland, Ohio, 44195, United States|Lehigh Valley Health Network, Allentown, Pennsylvania, 18103, United States|VA Pittsburg Healthcare System, Pittsburgh, Pennsylvania, 15240, United States|SC Nephrology and Hypertension Center, Inc., Orangeburg, South Carolina, 29118, United States|Knoxville Kidney Center, Knoxville, Tennessee, 37923, United States|Cardiothoracis and Vascular Surgeons, Austin, Texas, 78756, United States|Baylor College of Medicine, Houston, Texas, 77030, United States|The Methodist Hospital, Houston, Texas, 77030, United States|Lake Washington Vascular Center, Bellevue, Washington, 98004, United States|University of Wisconsin School of Medicine and PH, Madison, Wisconsin, 53792, United States|University of Alberta, Edmonton, Alberta, T6G2B7, Canada|Vancouver General Hospital, Vancouver, British Columbia, V5Z 1M9, Canada|London Health Science Center, London, Ontario, N6A 5W9, Canada|University Health Network Toronto General Hospital, Toronto, Ontario, M5G 2C4, Canada|McGill University Health Centre- Royal Victoria Hospital, Montreal, Quebec, H4A 3J1, Canada
URL: https://clinicaltrials.gov/show/NCT02414841

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress