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Clinical Trial Details

Trial ID: L2998
Source ID: NCT00283686
Associated Drug: Lisinopril
Title: HALT Progression of Polycystic Kidney Disease Study A
Acronym: HALT PKD A
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00283686/results
Conditions: Kidney, Polycystic
Interventions: DRUG: Lisinopril|DRUG: Telmisartan|DRUG: Placebo|OTHER: Standard Blood Pressure Control|OTHER: Low Blood Pressure Control
Outcome Measures: Primary: Study A: Percent Annual Change in Total Kidney Volume, Annual percentage change in total kidney volume as assessed by abdominal magnetic resonance imaging (MRI) at baseline, 2 years, 4 years, and 5 years follow-up., Baseline and 2-, 4- and 5-year follow-up | Secondary: Kidney Function (eGFR), The estimated GFR was calculated by means of the Chronic Kidney Disease Epidemiology Collaboration equation with the use of central serum creatinine measurements., Up to 96 months (6 month assessments)|Albuminuria, Urine albumin excretion, centrally processed from 24 hour urine collection, Up to 96 months (assessed annually)|Aldosterone, Urinary aldosterone excretion, centrally processed, 24 hour urine collection, Up to 96 months (assessed annually)|Left Ventricular Mass Index, Left ventricular mass index (g/m\^2) measured by MRI, centrally reviewed and measured, 0, 24 months, 48 months, 60 months|Renal Blood Flow, renal blood flow (mL/min/1.73 m\^2) from MRI, centrally reviewed and measured. This outcome was more difficult to measure resulting in more missing data than other MRI outcomes such as total kidney volume (TKV) and left ventricular mass index (LVMI)., 0, 24 months, 48 months, 60 months|All-Cause Hospitalizations, Up to 96 months|Quality of Life Physical Component Summary, Short Form-36 Quality of Life Physical Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome), baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually)|Quality of Life Mental Component Summary, Short Form-36 Quality of LIfe Mental Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome), baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually)
Sponsor/Collaborators: Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Collaborators: Boehringer Ingelheim|Merck Sharp & Dohme LLC|Polycystic Kidney Disease Foundation|University of Pittsburgh|Washington University School of Medicine
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE3
Enrollment: 558
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2006-01
Completion Date: 2014-06
Results First Posted: 2015-02-27
Last Update Posted: 2020-04-21
Locations: University of Colorado Health Sciences Center, Aurora, Colorado, 800045, United States|Emory University School of Medicine, Atlanta, Georgia, 30322, United States|University of Kansas Medical Center, Kansas City, Kansas, 66160, United States|Tufts University-New England Medical Center, Boston, Massachusetts, 02111, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States
URL: https://clinicaltrials.gov/show/NCT00283686

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D209 Lisinopril small molecule DB00722 Details
D282 Telmisartan small molecule DB00966 Details