| Trial ID: | L5515 |
| Source ID: | NCT01885559
|
| Associated Drug: |
Lisinopril
|
| Title: |
HALT Progression of Polycystic Kidney Disease Study B
|
| Acronym: |
HALT PKD B
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01885559/results
|
| Conditions: |
Kidney, Polycystic
|
| Interventions: |
DRUG: Lisinopril|DRUG: Telmisartan|DRUG: Placebo
|
| Outcome Measures: |
Primary: Number of Participants With 50% Reduction of Baseline eGFR, End Stage Renal Disease (ESRD, Initiation of Dialysis or Preemptive Transplant), or Death., Patients followed for 5-8 years with average of 6.5 years follow up | Secondary: Albuminuria, Annual percent change in 24 hour urine albumin, centrally processed. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope of the model). The measure presented is the average annual percent change across the 8 years., up to 8 years (annually assessed)|Aldosterone, Annual percent change in urinary aldosterone, centrally processed measure. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual percent change across the 8 years., up at 8 years (annually assessed)|Hospitalizations, Hospitalization for any cause, up to 8 years|Cardiovascular Hospitalizations, Cause-specific hospitalizations (cardiovascular), up to 8 years|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). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years., up to 8 years (annually assessed)|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). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years., up to 8 years (annually assessed)|Back or Flank Pain, Report of back or flank pain since the last visit (yes or no), 48 months
|
| 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: |
486
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-01
|
| Completion Date: |
2014-06
|
| Results First Posted: |
2015-03-10
|
| Last Update Posted: |
2020-04-22
|
| 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/NCT01885559
|
