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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. august 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

90

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Endy MR Endy Mohammed Rashad, assistant lecturer
  • Telefonnummer: 01064463176
  • E-mail: endyrashad@aun.edu.eg

Undersøgelse Kontakt Backup

  • Navn: Mohamed MHG Mohamed Mahmoud Hamdy Ghazaly, Professor
  • Telefonnummer: 01001296603
  • E-mail: ghazally@aun.edu.eg

Studiesteder

      • Asyut, Egypten
        • Assiut University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Endy MR Mahmoud, assistant lecturer, Assiut University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

  • [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:

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. oktober 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

20. august 2026

Først indsendt, der opfyldte QC-kriterier

22. august 2026

Først opslået (Faktiske)

25. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • renal biomarkers in sickle

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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