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

Sponsor
Ain Shams University
Study ID
NCT06982079
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • CKD Stage 4
  • Chronic Kidney Disease Stage 5

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
May 2025
Primary completion
Jun 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Eligible patients will receive dapagliflozin 10 mg in addition to standard of care
  • No Intervention: Control arm
    Eligible patients will receive standard of care only

Primary Outcome Measure

Change in the eGFR slope [ Time Frame: 1 year ]

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