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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 août 2026 mis à jour par: 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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

90

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Endy MR Endy Mohammed Rashad, assistant lecturer
  • Numéro de téléphone: 01064463176
  • E-mail: endyrashad@aun.edu.eg

Sauvegarde des contacts de l'étude

  • Nom: Mohamed MHG Mohamed Mahmoud Hamdy Ghazaly, Professor
  • Numéro de téléphone: 01001296603
  • E-mail: ghazally@aun.edu.eg

Lieux d'étude

      • Asyut, Egypte
        • Assiut University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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.
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

  • [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:

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

1 octobre 2027

Achèvement de l'étude (Estimé)

1 décembre 2027

Dates d'inscription aux études

Première soumission

20 août 2026

Première soumission répondant aux critères de contrôle qualité

22 août 2026

Première publication (Réel)

25 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • renal biomarkers in sickle

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .