KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease.
Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group
https://pubmed.ncbi.nlm.nih.gov/38490803Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID06982079
Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Kidney Function in Advanced Chronic Kidney Disease
Led by Ain Shams University · Updated on 2025-05-21
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether dapagliflozin can reduce the risk of worsening kidney function or death from heart and kidney causes in adults with advanced chronic kidney disease (CKD), including those with or without type 2 diabetes. This Phase 3 trial aims to fill a gap in knowledge since previous studies excluded patients with very low kidney function or those on dialysis. The study focuses on important questions about slowing kidney decline and reducing fatal cardiovascular and renal events in this high-risk group. Participants will be randomly assigned to receive either dapagliflozin 10 mg added to their usual care or standard care alone. The trial compares these two groups to assess if dapagliflozin improves kidney and heart outcomes. The treatment period is planned for at least one year, during which patients continue their regular medical care alongside the study interventions. During the study, participants will have their kidney function monitored through tests measuring the estimated glomerular filtration rate (eGFR) slope and the timing of any need for kidney replacement therapy. Hospitalizations for heart failure and overall survival will also be tracked. Safety will be assessed regularly, and the total participation time spans at least one year, with ongoing evaluations to understand the impact of dapagliflozin on advanced CKD.
CONDITIONS
Brief Title
Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Kidney Function in Advanced Chronic Kidney Disease
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients aged eighteen or older.
- Patients with advanced chronic kidney disease (eGFR less than 20 mL/min/1.73m2) not on dialysis.
You will not qualify if you...
- Autosomal dominant polycystic kidney disease (ADPKD).
- Type 1 diabetes mellitus.
- Patients currently on SGLT2 inhibitors.
- History of ketoacidosis in the last 3 months.
- Known hypersensitivity to SGLT2 inhibitors.
- Known hepatic impairment.
- Pregnant or breastfeeding females.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 1 year
Participants receive dapagliflozin 10 mg in addition to standard of care or standard of care alone to evaluate effects on kidney function.
Regular visits during treatment period
Trial Site Locations
Total: 1 location
1
Ain Shams University Hospitals
Cairo, Egypt
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
UK Kidney Association Clinical Practice Guideline: Sodium-Glucose Co-transporter-2 (SGLT-2) Inhibition in Adults with Kidney Disease 2023 UPDATE.
Alistair J Roddick, Alexa Wonnacott, David Webb...
https://pubmed.ncbi.nlm.nih.gov/37880609Effects of Sodium-Glucose Cotransporter 2 Inhibitors in Diabetic and Non-Diabetic Patients with Advanced Chronic Kidney Disease in Peritoneal Dialysis on Residual Kidney Function: In Real-World Data.
Esperanza Moral Berrio, José C De La Flor, Minerva Arambarri Segura...
https://pubmed.ncbi.nlm.nih.gov/39202480Change in Albuminuria and GFR as End Points for Clinical Trials in Early Stages of CKD: A Scientific Workshop Sponsored by the National Kidney Foundation in Collaboration With the US Food and Drug Administration and European Medicines Agency.
Andrew S Levey, Ron T Gansevoort, Josef Coresh...
https://pubmed.ncbi.nlm.nih.gov/31473020Chronic kidney disease.
Kamyar Kalantar-Zadeh, Tazeen H Jafar, Dorothea Nitsch...
https://pubmed.ncbi.nlm.nih.gov/34175022New Creatinine- and Cystatin C-Based Equations to Estimate GFR without Race.
Lesley A Inker, Nwamaka D Eneanya, Josef Coresh...
https://pubmed.ncbi.nlm.nih.gov/34554658Dapagliflozin in Patients with Chronic Kidney Disease.
Hiddo J L Heerspink, Bergur V Stefánsson, Ricardo Correa-Rotter...
https://pubmed.ncbi.nlm.nih.gov/32970396Effects of dapagliflozin on mortality in patients with chronic kidney disease: a pre-specified analysis from the DAPA-CKD randomized controlled trial.
Hiddo J L Heerspink, C David Sjöström, Niels Jongs...
https://pubmed.ncbi.nlm.nih.gov/33792669Forecasting life expectancy, years of life lost, and all-cause and cause-specific mortality for 250 causes of death: reference and alternative scenarios for 2016-40 for 195 countries and territories.
Kyle J Foreman, Neal Marquez, Andrew Dolgert...
https://pubmed.ncbi.nlm.nih.gov/30340847Safety of SGLT2 Inhibitors in CKD: Walking the Fine Line.
Mirela Dobre
https://pubmed.ncbi.nlm.nih.gov/35618341