NCT07785752

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
14mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 20, 2026

Last Update Submit

August 22, 2026

Conditions

Sickle Cell Nephropathy

Outcome Measures

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.

    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.

    1 year

Study Arms (3)

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.

Drug: Hydroxy Urea

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.

Drug: Hydroxy Urea

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.

Interventions

Hydroxy UreaDRUG

* 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 I (SCD patients on regular hydroxyurea therapy)Group II (SCD patients on irregular hydroxyurea therapy)

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (1)

  • [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:

    RESULT

MeSH Terms

Interventions

Hydroxyurea

Intervention Hierarchy (Ancestors)

UreaAmidesOrganic Chemicals

Study Officials

  • Endy MR Mahmoud, assistant lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Endy MR Endy Mohammed Rashad, assistant lecturer

CONTACT

01064463176endyrashad@aun.edu.eg

Mohamed MHG Mohamed Mahmoud Hamdy Ghazaly, Professor

CONTACT

01001296603ghazally@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of pediatric

Study Record Dates

First Submitted

August 20, 2026

First Posted

August 25, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 25, 2026

Record last verified: 2026-08

Locations

EG(1)