Health TrialsbyHealthPanel

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

ConditionsChronic Kidney Disease Stage 5CKD Stage 4
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAin Shams University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients aged eighteen or older.

Patients with advanced chronic kidney disease (i.e., eGFR < 20 mL/min/1.73m2)not on dialysis

Disqualifiers

Autosomal dominant polycystic kidney disease (ADPKD).

Type 1 diabetes mellitus

Patients on SGLT2 inhibitors.

History of ketoacidosis in the last 3 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin 10 mg

    Drug

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: DapagliflozinExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in the eGFR slope

To determine whether dapagliflozin is superior to standard of care only in reducing the eGFR slope.

Time frame
1 year
2

Time to start of renal replacement therapy

Kidney failure is defined as need for renal replacement therapy either by hemodialysis or kidney transplant

Time frame
1 year

Secondary outcomes

1

Incidence of hospitalization for heart failure

To determine if dapagliflozin is superior to standard of care only in reducing the incidence of heart failure

Time frame
1 year
2

Number of participants with all-cause mortality

To determine whether dapagliflozin is superior to standard of care only in reducing all-cause mortality

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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