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A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease (Dapa-CKD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03036150
Recruitment Status : Completed
First Posted : January 30, 2017
Results First Posted : July 7, 2021
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE January 26, 2017
First Posted Date  ICMJE January 30, 2017
Results First Submitted Date  ICMJE April 19, 2021
Results First Posted Date  ICMJE July 7, 2021
Last Update Posted Date July 7, 2021
Actual Study Start Date  ICMJE February 2, 2017
Actual Primary Completion Date June 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2021)		 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. [ Time Frame: Up to 38.2 months ]
End Stage Renal Disease (ESRD) is defined as:
  • Sustained eGFR <15 mL/min/1.73m2 or,
  • Chronic dialysis treatment or,
  • Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)		 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. [ Time Frame: From randomization (Day 0) up to approximately 4 years ]
End Stage Renal Disease (ESRD) is defined as:
  • Sustained eGFR <15 mL/min/1.73m2 or,
  • Chronic dialysis treatment or,
  • Receiving a renal transplant
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2021)
  • Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death. [ Time Frame: Up to 38.2 months ]
    End Stage Renal Disease (ESRD) is defined as:
    • Sustained eGFR <15 mL/min/1.73m2 or,
    • Chronic dialysis treatment or,
    • Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.
  • Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure. [ Time Frame: Up to 38.2 months ]
    The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.
  • Time to Death From Any Cause. [ Time Frame: Up to 38.2 months ]
    The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • Time to the first occurrence of any of the components of the composite: ≥50% sustained decline in eGFR or reaching ESRD or renal death. [ Time Frame: From randomization (Day 0) up to approximately 4 years ]
  • Time to the first occurrence of either of the components of the composite: CV death or hospitalization for heart failure. [ Time Frame: From randomization (Day 0) up to approximately 4 years ]
  • Time to death from any cause. [ Time Frame: From randomization (Day 0) up to approximately 4 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
Official Title  ICMJE A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
Brief 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.
Detailed Description This is an international, multicentre, event-driven, randomized, double-blind, parallel group, placebo-controlled study, evaluating the effect of dapagliflozin versus placebo, given once daily in addition to standard of care, to prevent the progression of chronic kidney disease (CKD) or cardiovascular (CV)/renal death.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE
  • Drug: Dapagliflozin
    10 mg or 5 mg tablets given once daily, per oral use.
    Other Names:
    • Forxiga TM
    • Farxiga TM
  • Drug: Placebo
    Placebo matching dapagliflozin 10 mg or 5 mg
Study Arms  ICMJE
  • Experimental: Dapagliflozin
    Patients will be randomized 1:1 to either dapagliflozin or placebo.
    Intervention: Drug: Dapagliflozin
  • Placebo Comparator: Placebo
    Placebo matching dapagliflozin.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2020)		 4304
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2017)		 4000
Actual Study Completion Date  ICMJE June 12, 2020
Actual Primary Completion Date June 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Canada,   China,   Denmark,   Germany,   Hungary,   India,   Japan,   Korea, Republic of,   Mexico,   Peru,   Philippines,   Poland,   Russian Federation,   Spain,   Sweden,   Ukraine,   United Kingdom,   United States,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03036150
Other Study ID Numbers  ICMJE D169AC00001
2016-003896-24 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party AstraZeneca
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AstraZeneca
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP