About this trial
To evaluate the diagnostic performance of urinary N-acetyl-β-D-glucosaminidase (NAG) and kidney injury molecule-1 (KIM-1) Biomarkers for detection of early onset of Sickle Cell Nephropathy in children under HU therapy
Eligibility criteria
This trial accepts healthy volunteersQualifiers
• Children and adolescents aged less than 18 years.
Confirmed diagnosis of sickle cell disease by hemoglobin electrophoresis and/or high-performance liquid chromatography (HPLC).
Clinically stable patients at the time of enrollment, with no acute vaso-occlusive crisis or acute illness.
Disqualifiers
• Age ≥18 years.
Acute sickle cell crisis at least 3 week prior to sample collection
Acute infection or fever.
Known chronic kidney disease due to causes other than sickle cell disease.
Trial population
The study population will include children with confirmed sickle cell disease attending the Hematology Unit, Assiut University Children's Hospital, during the study period.
Trial design
Case-control
Prospective
Treatments tested in this trial
Hydroxy Urea
Drug* Assessment of the diagnostic performance of urinary N-acetyl-β-D-glucosaminidase (NAG) and Kidney Injury Molecule-1 (KIM-1) for early detection of early onset of sickle cell nephropathy in children with sickle cell disease on regular hydroxyurea * Assessment of renal diffusion MRI parameters (DWI/DTI), particularly fractional anisotropy (FA), in children with sickle cell disease.
Treatment groups
Trial outcomes
Primary outcomes
To assess differences in kidney function and early renal injury between the study groups using urinary N-acetyl-β-D-glucosaminidase (NAG), Kidney Injury Molecule-1 (KIM-1), and to evaluate the diagnostic performance of these measures for the early detect
To assess differences in kidney function and early renal injury between the study groups using urinary N-acetyl-β-D-glucosaminidase (NAG), Kidney Injury Molecule-1 (KIM-1), and to evaluate the diagnostic performance of these measures for the early detection of sickle cell nephropathy and assessment of renal diffusion MRI parameters (DWI/DTI), particularly fractional anisotropy (FA), in children with sickle cell disease.
Secondary outcomes
Evaluation of the diagnostic performance of urinary NAG and KIM-1 using ROC curve analysis and Correlation between renal DWI/DTI findings and urinary NAG, KIM-1, ACR, and eGFR.
* Correlation of urinary NAG and KIM-1 levels with urinary albumin-to-creatinine ratio (ACR) and estimated glomerular filtration rate (eGFR). * Evaluation of the diagnostic performance of urinary NAG and KIM-1 using ROC curve analysis. * Determination of sensitivity, specificity, PPV, NPV, and diagnostic accuracy of the studied biomarkers. * Assessment of renal diffusion MRI parameters (DWI/DTI), particularly fractional anisotropy (FA), in children with sickle cell disease. * Correlation between renal DWI/DTI findings and urinary NAG, KIM-1, ACR, and eGFR. * Evaluation of the ability of DWI/DTI to detect early renal microstructural changes before overt impairment of renal function.
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