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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 (sickle nephro)

22 de agosto de 2026 actualizado por: Endy Mohammed Rashad Mahmoud, Assiut University
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

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Sickle cell disease was the first condition to be understood as a molecular disease, as described by Pauling and colleagues in 1949, and later helped to elucidate principles of gene expression, haemoglobin switching, and globin gene regulation.

Sickle cell disease refers to a group of inherited red blood cell (RBC) disorders caused by pathogenic variants in the HBB gene, resulting in the production of sickle haemoglobin S (HbS). Individuals with one copy of the mutation have sickle cell trait a condition that confers partial protection against severe malaria while those with pathogenic variants on both alleles develop the clinical syndrome of sickle cell disease.

The defining pathophysiological mechanism of sickle cell disease is the polymerization of deoxygenated HbS, leading to red cell sickling, haemolysis, and vaso-occlusion accompanied by a cascade of complex pathophysiological events. This cascade drives the multisystem complications of the disease, including acute painful crisis, acute chest syndrome, stroke and cognitive impairment, and progressive organ damage.

Sickle nephropathy often begins in childhood with impaired urine concentrating ability and glomerular hyperfiltration, eventually progressing to albuminuria, reduced glomerular filtration rate, and end-stage renal disease.

Up to one-third of adults with sickle cell disease develop overt proteinuria or decreased glomerular filtration rate, and kidney dysfunction is independently associated with early mortality. Hydroxyurea and angiotensin-converting enzyme inhibitors remain first-line therapies for reducing albuminuria and slowing progression.

Early onset SCN is a progressive kidney complication in SCD driven by chronic RBC sickling, vascular occlusion and hemolysis, typically begins in early childhood with hyperfiltration, hyposthenuria, and microalbuminuria.

Enuresis is another frequent complication that affects quality of life. Genetic modifiers, such as high fetal hemoglobin (HbF) levels and α-thalassemia trait have a protective effect on nephropathy, possibly by reduced hemolysis and endothelial stress.

Renal damage is common in children patients with SCD, which begins in childhood, progressing with age, a fact that makes nephropathy one of the possible complications. This can compromise patients' quality of life and decrease survival.

Sickle cell nephropathy (SCN) is a severe complication of SCA, characterized by early, often asymptomatic onset in childhood and a potential progression to chronic kidney disease (CKD) . SCN presents a significant challenge in the clinical management of patients with sickle cell anemia, contributing to a reduction in life expectancy by approximately 20 to 30 years. The clinical progression of SCN is age-dependent, with renal dysfunction typically emerging during childhood and gradually advancing to chronic kidney disease and, ultimately, kidney failure by the third or fourth decade of life.

Classical biomarkers such as creatinine, are not able to detect early renal lesions, which makes kidney injury molecule-1 (Kim-1) and N-acetyl-b-D-glucosaminidase (NAG) possible biomarker candidates in the prediction of renal disease in sickle cell anemia patients.

Despite advancements in treatment of sickle cell disease (SCD), hydroxyurea, a ribonucleotide reductase inhibitor, remains the cornerstone of therapy. While its primary effect is the elevation of fetal hemoglobin (HbF), hydroxyurea's mechanisms of action are multifaceted. Hydroxyurea (HU) reduces leukocyte and platelet counts, decreases the expression of endothelial adhesion molecules CD36 and CD49d, and increases nitric oxide and cyclic nucleotide levels, which may facilitate vascular dilation and further HbF induction.

Tipo de estudio

De observación

Inscripción (Estimado)

90

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Endy MR Endy Mohammed Rashad, assistant lecturer
  • Número de teléfono: 01064463176
  • Correo electrónico: endyrashad@aun.edu.eg

Copia de seguridad de contactos de estudio

  • Nombre: Mohamed MHG Mohamed Mahmoud Hamdy Ghazaly, Professor
  • Número de teléfono: 01001296603
  • Correo electrónico: ghazally@aun.edu.eg

Ubicaciones de estudio

      • Asyut, Egipto
        • Assiut University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra de probabilidad

Población de estudio

The study population will include children with confirmed sickle cell disease attending the Hematology Unit, Assiut University Children's Hospital, during the study period.

Descripción

Inclusion Criteria:

  • • 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.

Exclusion Criteria:

  • • 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.
    • Congenital renal anomalies.
    • Diabetes mellitus.
    • Hypertension.
    • Current use of nephrotoxic medications.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Group I (SCD patients on regular hydroxyurea therapy)
Children with confirmed sickle cell disease receive hydroxyurea regularly, regardless of the presence or absence of early renal involvement.
  • 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.
Group II (SCD patients on irregular hydroxyurea therapy)
Children with confirmed sickle cell disease receiving hydroxyurea irregularly or demonstrating poor adherence to treatment, regardless of the presence or absence of early renal involvement.
  • 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.
Apparently healthy age- and sex-matched children with no history of sickle cell disease
Apparently healthy age- and sex-matched children with no history of sickle cell disease, renal disease, hypertension, or diabetes mellitus.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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
Periodo de tiempo: 1 year
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.
1 year

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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.
Periodo de tiempo: 1 year
  • 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.
1 year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Endy MR Mahmoud, assistant lecturer, Assiut University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

  • [1] R. E. Ware, M. de Montalembert, L. Tshilolo, and M. R. Abboud, "Sickle cell disease," The Lancet, vol. 390, no. 10091, pp. 311-323, 2017. [2] F. B. Piel, M. H. Steinberg, and D. C. Rees, "Sickle cell disease," New England Journal of Medicine, vol. 376, no. 16, pp. 1561-1573, 2017. [3] R. Colombatti, W. Jastaniah, J. Makani, and B. Andemariam, "Sickle cell disease," The Lancet, vol. 407, no. 10533, pp. 1095-1111, Mar. 2026, doi: 10.1016/S0140-6736(25)02278-0. [4] K. I. Ataga, S. L. Saraf, and V. K. Derebail, "The nephropathy of sickle cell trait and sickle cell disease," Nat. Rev. Nephrol., vol. 18, no. 6, pp. 361-377, 2022. [5] B. P. D. Inusa et al., "Sickle Cell Nephropathy: Current Understanding of the Presentation, Diagnostic and Therapeutic Challenges," Hematology - Latest Research and Clinical Advances, Jun. 2018, doi: 10.5772/INTECHOPEN.76588. [6] R. P. Brandsen et al., "The role of red blood cell characteristics and viscosity in sickle cell retinopathy and maculopathy," Br. J. Haematol., vol. 206, no. 6, pp. 1796-1805, 2025. [7] F. Neto, M. Santos, E. Adôrno, J. Ferreira, M. Gonçalves, and C. Barbosa, "EARLY URINARY BIOMARKERS OF RENAL DAMAGE IN SICKLE CELL DISEASE PATIENTS," Hematol. Transfus. Cell Ther., vol. 46, p. S72, Oct. 2024, doi: 10.1016/J.HTCT.2024.09.120. [8] A. Busari, S. Jolayemi, M. Ahmad, R. P.-A. MEDICA, and undefined 2026, "Assessment of Urine Kidney Injury Molecule-1 as an Early Biomarker for Nephropathy in Sickle Cell Anaemia Patients," karolinum.czAO Busari, SL Jolayemi, MB Ahmad, RT PerdomoACTA MEDICA, 2026•karolinum.cz, 2025, doi: 10.14712/18059694.2025.27. [9] M. López Rubio and M. Argüello Marina, "The Current Role of Hydroxyurea in the Treatment of Sickle Cell Anemia," Journal of Clinical Medicine 2024, Vol. 13, vol. 13, no. 21, Oct. 2024, doi: 10.3390/JCM13216404. [10] G. J. Schwartz et al., "New equations to estimate GFR in children with CKD," Journal of the American Society of Nephrology, vol. 20, no. 3, pp. 629-637, 2009, doi:

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

1 de octubre de 2027

Finalización del estudio (Estimado)

1 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

20 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de agosto de 2026

Publicado por primera vez (Actual)

25 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • renal biomarkers in sickle

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .