Clinical Utility of Urinary N-Acetyl-β-D-Glucosaminidase (NAG), Kidney Injury Molecule-1 (KIM-1), and Diffusion-Weighted Renal MRI for the Early Detection of Sickle Cell Nephropathy in Children

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-18
SponsorAssiut University

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 volunteers

Qualifiers

• 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

Design model

Case-control

Time perspective

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

90 Participants
are divided into 3 treatment groups
Group A: Group I (SCD patients on regular hydroxyurea therapy)1 intervention
Group B: Group II (SCD patients on irregular hydroxyurea therapy)1 intervention
Group C: Apparently healthy age- and sex-matched children with no history of sickle cell disease0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year

Secondary outcomes

1

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.

Time frame
1 year

Other outcomes

Sponsors and contacts

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