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
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