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Study of a medicine to assess safety, effects, and how it works in the body of children with chronic kidney disease

Prospective open-label interventional clinical trial evaluating the efficacy, safety, and pharmacokinetics of SGLT-2 inhibitors in pediatrics with chronic kidney disease

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
PACTR
Registry ID
PACTR202511687575219
Enrollment
60
Registered
2025-11-24
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genetic Diseases Paediatrics Kidney Disease

Interventions

Dapagliflozin

Sponsors

None
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age 2–18 years with CKD stages 2–4 (eGFR 15–89 mL/min/1.73 m²). Proteinuria/elevated albuminuria (uACR or uPCR >0.2 mg/mg).

Exclusion criteria

Exclusion criteria: Diabetic children. Acute kidney injury <3 months. Pregnancy. Patients with known contraindications.

Design outcomes

Primary

MeasureTime frame
Evaluate change in eGFR slope over study duration.

Secondary

MeasureTime frame
Assess change in urine albumin/creatinine or protein/creatinine ratio, safety, blood pressure, growth parameters and drug pharmacokinetics.

Countries

Egypt

Contacts

Public ContactAhmed;Noha El Koraey;Hamdy

Professor of Internal Medicine and Head of Nephrology and Kidney Transplantation Department Alexandria University Hospital;Acting head of Clinical Pharmacy and Pharmacy Practice Department Faculty of Pharmacy Alexandria University

drahmed@hotmail.com;noha.alaaeldine@alexu.edu.eg0201000304563;0201005182151

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026