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Clinical Trial Details

Trial ID: L0918
Source ID: NCT01989078
Associated Drug: Losartan
Title: Losartan for Sickle Cell Kidney Disease
Acronym: SCD-Losartan
Status: COMPLETED
Study Results: NO
Results:
Conditions: Sickle Cell Disease
Interventions: DRUG: Losartan
Outcome Measures: Primary: Change in albumin/creatinine ratio (ACR), The effects of losartan on the mean change in albumin/creatinine ratio (ACR) will be examined., Baseline, Month 1, End of treatment (12 to 24 months)|Change in glomerular filtration rate (GFR), The effects of losartan on the mean change in glomerular filtration rate (GFR) will be examined., Baseline, Month 1, End of treatment (12 to 24 months)|Change in renal plasma flow (RPF), The effects of losartan on the mean change in renal plasma flow (RPF) will be examined., Baseline, Month 1, End of treatment (12 to 24 months)|Change in glomerular permeability (GP), The effects of losartan on the mean change in glomerular permeability (GP) will be examined., Baseline, Month 1, End of treatment (12 to 24 months) | Other: Association between changes in albumin/creatinine ratio (ACR) at one month and glomerular filtration rate (GFR) at 12 months, For the exploratory aims, the relationship between the degree of short-term change in albumin/creatinine ratio (ACR) and longer-term changes in glomerular filtration rate (GFR) will be examined. The mean change in urinary ACR after 1 month of treatment with losartan will be associated with the long-term mean changes in GFR after 12 months of treatment., Baseline, Month 1, End of treatment (12 to 24 months)|Association between changes in albumin/creatinine ratio (ACR) at one month and renal plasma flow (RPF) at 12 months, For the exploratory aims, the relationship between the degree of short-term change in albumin/creatinine ratio (ACR) and longer-term changes in renal plasma flow (RPF) will be examined. The mean change in urinary ACR after 1 month of treatment with losartan will be associated with the long-term mean changes in RPF after 12 months of treatment., Baseline, Month 1, End of treatment (12 to 24 months)|Association between changes in albumin/creatinine ratio (ACR) at one month and glomerular permeability (GP) at 12 months, For the exploratory aims, the relationship between the degree of short-term change in albumin/creatinine ratio (ACR) and longer-term changes in glomerular permeability (GP) will be examined. The mean change in urinary ACR after 1 month of treatment with losartan will be associated with the long-term mean changes in GP after 12 months of treatment., Baseline, Month 1, End of treatment (12 to 24 months)
Sponsor/Collaborators: Sponsor: Emory University
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases: EARLY_PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-12
Completion Date: 2016-12
Results First Posted:
Last Update Posted: 2017-07-17
Locations: Grady Health Systems, Atlanta, Georgia, 30303, United States|Children's Healthcare of Atlanta, Atlanta, Georgia, 30322, United States
URL: https://clinicaltrials.gov/show/NCT01989078