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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)

2026년 8월 22일 업데이트: 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

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (추정된)

90

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Endy MR Endy Mohammed Rashad, assistant lecturer
  • 전화번호: 01064463176
  • 이메일: endyrashad@aun.edu.eg

연구 연락처 백업

  • 이름: Mohamed MHG Mohamed Mahmoud Hamdy Ghazaly, Professor
  • 전화번호: 01001296603
  • 이메일: ghazally@aun.edu.eg

연구 장소

      • Asyut, 이집트
        • Assiut University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

확률 샘플

연구 인구

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

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
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.
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Endy MR Mahmoud, assistant lecturer, Assiut University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

  • [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:

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 1일

기본 완료 (추정된)

2027년 10월 1일

연구 완료 (추정된)

2027년 12월 1일

연구 등록 날짜

최초 제출

2026년 8월 20일

QC 기준을 충족하는 최초 제출

2026년 8월 22일

처음 게시됨 (실제)

2026년 8월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 22일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • renal biomarkers in sickle

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미정

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