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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)

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Dapagliflozin Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
Actual Study Start Date : February 2, 2017
Actual Primary Completion Date : June 12, 2020
Actual Study Completion Date : June 12, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dapagliflozin
Patients will be randomized 1:1 to either dapagliflozin or placebo.
 Drug: Dapagliflozin
10 mg or 5 mg tablets given once daily, per oral use.
Other Names:
  • Forxiga TM
  • Farxiga TM
Placebo Comparator: Placebo
Placebo matching dapagliflozin.
 Drug: Placebo
Placebo matching dapagliflozin 10 mg or 5 mg


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036150


Locations
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Sponsors and Collaborators
AstraZeneca
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Study Protocol  [PDF] March 17, 2020
Statistical Analysis Plan  [PDF] April 15, 2020

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03036150    
Other Study ID Numbers: D169AC00001
2016-003896-24 ( EudraCT Number )
First Posted: January 30, 2017    Key Record Dates
Results First Posted: July 7, 2021
Last Update Posted: July 7, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Chronic Kidney Disease (CKD)
Cardiovascular Events (CV)
Phase III outcome trial
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Renal Insufficiency
 Chronic Disease
Disease Attributes
Pathologic Processes
Dapagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs