Phase 3
Completed N=4,304
A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
Source: ClinicalTrials.gov NCT03036150 ↗Enrolled (actual)
4,304
Serious AEs
31.7%
Results posted
Jul 2021
Primary outcomePrimary: Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death. — 197; 312 Participants — p=< 0.0001
◆ Published Evidence
Emerging
6citations · ~6 / year
Effects of Dapagliflozin on Health-Related Quality of Life in Patients with CKD.
Summary
The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease.
Linked Publications (5)
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Effects of Dapagliflozin on Health-Related Quality of Life in Patients with CKD.
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Use of eGFR Slope Thresholds as End Point Components in a Kidney Disease Progression Hierarchical Composite End Point.
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Association of Urinary EGF with Kidney Outcomes and Effects of Sodium-Glucose Cotransporter 2 Inhibition.
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Sodium-Glucose Cotransporter 2 Inhibition and Hospitalizations in Patients with CKD: A Meta-Analysis of Kidney Outcome Trials.
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Effects of Dapagliflozin on Progression of CKD According to Different Rates of Pretrial eGFR Loss.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death. |
197; 312 | < 0.0001 sig |
| SECONDARY Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death. |
142; 243 | < 0.0001 sig |
| SECONDARY Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure. |
100; 138 | 0.0089 sig |
| SECONDARY Time to Death From Any Cause. |
101; 146 | 0.0035 sig |
Eligibility Criteria
Inclusion Criteria
- Provision of signed informed consent prior to any study specific procedures
- Female or male aged ≥18 years at the time of consent
- eGFR ≥25 and ≤75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1
- Evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥200 and ≤5000 mg/g at visit 1
- Stable, and for the patient maximum tolerated labelled daily dose, treatment with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated,
Exclusion Criteria
- Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis
- Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
- History of organ transplantation
- Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
- Type 1 diabetes mellitus
- New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment
- MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
Data sourced from ClinicalTrials.gov (NCT03036150) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.