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Recruiting Phase 3

Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Kidney Function in Advanced Chronic Kidney Disease

NCT06982079 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 3
Started
2025-05-01
Last updated
2025-05-21

Condition(s) studied

Chronic Kidney Disease Stage 5CKD Stage 4

Investigational drug(s) / intervention(s)

Dapagliflozin 10 mg →

Dapagliflozin 10 mg: Dapagliflozin 10 mg will be added in addition to standard of care

Study summary

The goal of this clinical trial is to evaluate whether dapagliflozin can reduce the risk of worsening kidney function or death from cardiovascular or renal causes in adults with advanced chronic kidney disease (CKD), with or without type 2 diabetes. The main questions it aims to answer are:

1. Does dapagliflozin reduce the rate of decline in kidney function or progression to end-stage kidney disease in adults with advanced CKD?
2. Does dapagliflozin reduce the risk of death from cardiovascular or renal causes in patients with advanced CKD?

Researchers will compare dapagliflozin to a placebo to see if dapagliflozin improves kidney and cardiovascular outcomes in this high-risk population.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patients aged eighteen or older. * Patients with advanced chronic kidney disease (i.e., eGFR \< 20 mL/min/1.73m2)not on dialysis Exclusion Criteria: * Autosomal dominant polycystic kidney disease (ADPKD). * Type 1 diabetes mellitus * Patients on SGLT2 inhibitors. * History of ketoacidosis in the last 3 months. * Known hypersensitivity to SGLT2 inhibitors. * Known hepatic impairment. * Pregnant or breastfeeding females.

Primary outcome measure(s)

  • Change in the eGFR slope — 1 year
    To determine whether dapagliflozin is superior to standard of care only in reducing the eGFR slope.
  • Time to start of renal replacement therapy — 1 year
    Kidney failure is defined as need for renal replacement therapy either by hemodialysis or kidney transplant

Trial sites (1)

FacilityCityRegionStatus
Ain Shams University Hospitals Cairo Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06982079 on ClinicalTrials.gov ↗ ← All trials in Egypt