Related Experiment Video
Updated: Dec 29, 2025
Author Spotlight: Network Pharmacology and Molecular Docking to Decipher the Action of Jiawei Shengjiang San Against Diabetic Kidney Disease
Published on: May 10, 2024
Rationale and protocol of the Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD)
Hiddo J L Heerspink1,2, Bergur V Stefansson3, Glenn M Chertow4
1Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Background:
Recent cardiovascular outcome trials have shown that sodium-glucose co-transporter 2 (SGLT2) inhibitors slow the progression of chronic kidney disease (CKD) in patients with type 2 diabetes at high cardiovascular risk. Whether these benefits extend to CKD patients without type 2 diabetes or cardiovascular disease is unknown. The Dapagliflozin and Prevention of Adverse Outcomes in CKD (DAPA-CKD) trial (NCT03036150) will assess the effect of the SGLT2 inhibitor dapagliflozin on renal and cardiovascular events in a broad range of patients with CKD with and without diabetes.
Methods:
DAPA-CKD is a randomized, double-blind, placebo-controlled, trial in which ∼4300 patients with CKD Stages 2-4 and elevated urinary albumin excretion will be enrolled. The vast majority will be receiving a maximum tolerated dose of a renin-angiotensin system inhibitor at enrolment.
Results:
After a screening assessment, eligible patients with a urinary albumin:creatinine ratio ≥200 mg/g and estimated glomerular filtration rate (eGFR) between 25 and 75 mL/min/1.73 m2 are randomly assigned to placebo or dapagliflozin 10 mg/day. Enrolment is monitored to ensure that at least 30% of patients do not have diabetes and that no more than 10% have an eGFR >60 mL/min/1.73 m2. The primary endpoint is a composite of a sustained decline in eGFR of ≥50%, end-stage renal disease, renal death or cardiovascular death. The trial will conclude when 681 primary renal events have occurred, providing 90% power to detect a 22% relative risk reduction (α level of 0.05).
Conclusion:
DAPA-CKD will determine whether the SGLT2 inhibitor dapagliflozin, added to guideline-recommended therapies, safely reduces the rate of renal and cardiovascular events in patients across multiple CKD stages with and without diabetes.
Insights
The DAPA-CKD trial investigates if dapagliflozin benefits chronic kidney disease (CKD) patients without diabetes. This study assesses the drug
Area of Science:
- Nephrology
- Cardiology
- Pharmacology
Background:
- Sodium-glucose co-transporter 2 (SGLT2) inhibitors show promise in slowing chronic kidney disease (CKD) progression in type 2 diabetes patients.
- Evidence is lacking on SGLT2 inhibitors' effects in CKD patients without diabetes or cardiovascular disease.
Purpose of the Study:
- To evaluate the efficacy of dapagliflozin in reducing renal and cardiovascular events in a diverse CKD population.
- To determine if dapagliflozin offers benefits beyond guideline-recommended therapies for CKD management.
Main Methods:
- The DAPA-CKD trial is a randomized, double-blind, placebo-controlled study enrolling approximately 4300 CKD patients (Stages 2-4) with elevated albuminuria.
- Patients receive either dapagliflozin 10 mg/day or a placebo, alongside maximally tolerated renin-angiotensin system inhibitors.
- The primary endpoint is a composite of sustained eGFR decline, end-stage renal disease, or renal/cardiovascular death.
Main Results:
- The study is designed to detect a 22% relative risk reduction in primary events with 90% power.
- Enrollment criteria ensure representation of patients with and without diabetes, and varying eGFR levels.
Conclusions:
- The DAPA-CKD trial will ascertain if dapagliflozin provides renal and cardiovascular protection in a broad spectrum of CKD patients.
- Findings will clarify the role of SGLT2 inhibitors in managing CKD, irrespective of diabetic status.
Related Concept Videos
01:23Dipeptidyl Peptidase 4 Inhibitors
01:28Drug Dosing in Renal Diseases: Estimation of Glomerular Filtration Rate Based on Serum Creatinine Concentration
01:30Acute Kidney Injury IV: Diagnostic Studies and Prevention
01:28Chronic Kidney Disease III: Interprofessional Care
01:20Acute Kidney Injury V: Interprofessional Care
01:25Drug Dosing in Renal Diseases: Dose Adjustments Based on Drug Clearance and Elimination Rate Constant