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Clinical Trial Details

Trial ID: L1007
Source ID: NCT04335721
Associated Drug: Voxelotor
Title: A Voxelotor for Sickle Cell Anemia Patients at Highest Risk for Progression of Chronic Kidney Disease
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Sickle Cell Disease|Sickle Cell Nephropathy
Interventions: DRUG: Voxelotor
Outcome Measures: Primary: Change in albuminuria in voxelotor-treated SCA patients compared to the observation patients by a one-sided test, Albuminuria will be analyzed comparing the mean values from the Week 47 and 48 visits to the mean values from the baseline and screening visits, 48 weeks | Secondary: Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values in albuminuria, Proportion of subjects achieving a 25% decline in albuminuria in the voxelotor-treated group compared to the observation group, 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values in kidney function measure, 24 hour urine protein, 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values in In kidney function measure, 24 hour urine eGFR, 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values in kidney function measure, 24 hour urine albumin concentration, 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values in kidney function measure, 24 hour serum creatinine, 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values in Kidney function measure, 24 hour serum cystatin C, 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values in Kidney function measure, 24 hour serum BUN, 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values in Kidney function measure, CKD stage, 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values kidney function measure, 24 hour urine retinol binding protein, 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values kidney function measure, 24 hour urine β2 microglobulin, 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values kidney function measure, Plasma cell-free hemoglobin, 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values kidney function measure, Urine hemoglobin, 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values kidney function measure, Urine dipstick-defined hemoglobinuria), 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values markers of hemolysis, Lactate dehydrogenase (LDH), 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values markers of hemolysis, Aspartate aminotransferase (AST), 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values markers of hemolysis, Indirect bilirubin, 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values markers of hemolysis, Reticulocyte%, 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values markers of hemolysis, Hemoglobin concentration, 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values kidney injury biomarker, Urine nephrin, 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values kidney injury biomarker, Urine podocalyxin, 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values kidney injury biomarker, Urine KIM-1, 48weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values kidney injury biomarker, Urine NGAL, 48 weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values oxidative injury biomarker, Serum Methylenedioxyamphetamine (MDA), 48weeks|Change from the average of the Screening and Baseline values to the Week 47 and Week 48 values oxidative injury biomarker, Serum 8-OHd, 48 weeks
Sponsor/Collaborators: Sponsor: University of Illinois at Chicago | Collaborators: Global Blood Therapeutics
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 12
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-03-16
Completion Date: 2024-10-07
Results First Posted:
Last Update Posted: 2025-04-03
Locations: University of Illinois, Chicago, Illinois, 60612, United States
URL: https://clinicaltrials.gov/show/NCT04335721