RecruitingPhase 3NCT06982079

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


Sponsor

Ain Shams University

Enrollment

60 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • Adult patients aged eighteen or older.
  • Patients with advanced chronic kidney disease (i.e., eGFR \< 20 mL/min/1.73m2)not on dialysis

Exclusion Criteria7

  • 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.

Interventions

DRUGDapagliflozin 10 mg

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


Locations(1)

Ain Shams University Hospitals

Cairo, Egypt

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NCT06982079


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