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Clinical Trial Details

Trial ID: L4377
Source ID: NCT00555217
Associated Drug: Losartan
Title: VA NEPHRON-D: Diabetes iN Nephropathy Study
Acronym: VA NEPHRON-D
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00555217/results
Conditions: Kidney Disease|Nephropathy|Type 2 Diabetes
Interventions: DRUG: losartan|DRUG: lisinopril
Outcome Measures: Primary: A Composite Endpoint of Reduction in Estimated GFR of 30ml/Min/1.73m*m in Individuals w/a Baseline Estimated GFR >= 60 ml/Min/1.73m*m, Reduction in Estimated GFR >50% in Individuals w/ Baseline Estimated GFR <60ml/Min/1.73m*m; ESRD or Death, Time to the first event of reduction in estimated GFR of 30ml/min/1.73m\*m in individuals w/a baseline estimated GFR \>= 60 ml/min/1.73m\*m, reduction in estimated GFR \>50% in individuals w/ baseline estimated GFR \<60ml/min/1.73m\*m; ESRD or death., From enrollemnt to time of first primary event, up to 4.5 years | Secondary: A Renal Composite Endpoint, Defined as; Reduction in Estimated GFR of >50% (for Individuals With Baseline GFR <60) or Reduction in GFR of >30 (for Individuals With Baseline GFR >= GFR 60) or ESRD., Time to the first event of reduction in estimated GFR of \>50% (for individuals with baseline GFR \<60) or reduction in GFR of \>30 (for individuals with baseline GFR \>= GFR 60) or ESRD., From enrollment to time of first event, up to 4.5 years
Sponsor/Collaborators: Sponsor: US Department of Veterans Affairs
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1448
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2008-07
Completion Date: 2014-10
Results First Posted: 2015-05-29
Last Update Posted: 2015-05-29
Locations: Carl T. Hayden VA Medical Center, Phoenix, Arizona, 85012, United States|Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock, Little Rock, Arkansas, 72205-5484, United States|VA Medical Center, Loma Linda, Loma Linda, California, 92357, United States|VA Palo Alto Health Care System, Palo Alto, California, 94304-1290, United States|VA Connecticut Health Care System (West Haven), West Haven, Connecticut, 06516, United States|North Florida/South Georgia Veterans Health System, Gainesville, Florida, 32608, United States|VA Medical Center, Miami, Miami, Florida, 33125, United States|James A. Haley Veterans Hospital, Tampa, Tampa, Florida, 33612, United States|Edward Hines, Jr. VA Hospital, Hines, Illinois, 60141-5000, United States|Richard Roudebush VA Medical Center, Indianapolis, Indianapolis, Indiana, 46202-2884, United States|VA Medical Center, Iowa City, Iowa City, Iowa, 52246-2208, United States|VA Maryland Health Care System, Baltimore, Baltimore, Maryland, 21201, United States|VA Medical Center, Minneapolis, Minneapolis, Minnesota, 55417, United States|VA Medical Center, Kansas City MO, Kansas City, Missouri, 64128, United States|VA Medical Center, St Louis, St Louis, Missouri, 63106, United States|VA Medical Center, Omaha, Omaha, Nebraska, 68105-1873, United States|VA New Jersey Health Care System, East Orange, East Orange, New Jersey, 07018, United States|New Mexico VA Health Care System, Albuquerque, Albuquerque, New Mexico, 87108-5153, United States|VA Western New York Healthcare System at Buffalo, Buffalo, New York, 14215, United States|VA Medical Center, Durham, Durham, North Carolina, 27705, United States|VA Medical Center, Cleveland, Cleveland, Ohio, 44106, United States|VA Medical Center, Portland, Portland, Oregon, 97201, United States|VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA, Pittsburgh, Pennsylvania, 15240, United States|Ralph H Johnson VA Medical Center, Charleston, Charleston, South Carolina, 29401-5799, United States|WJB Dorn Veterans Hospital, Columbia, Columbia, South Carolina, 29209, United States|VA Medical Center, Memphis, Memphis, Tennessee, 38104, United States|VA Medical Center, Nashville, Tennessee, 37212-2637, United States|VA North Texas Health Care System, Dallas, Dallas, Texas, 75216, United States|Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, 23249, United States|Zablocki VA Medical Center, Milwaukee, Milwaukee, Wisconsin, 53295-1000, United States|VA Medical Center, San Juan, San Juan, 00921, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT00555217