A study to evaluate if dapagliflozin can prevent the gradual loss of kidney function and improve survival for patients with chronic kidney disease.

A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients with Chronic Kidney Disease - DAPA CKD

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003896-24-SE

Enrollment

4000

Registered

2016-11-29

Start date

2017-01-25

Completion date

Unknown

Last updated

2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease (CKD)

Interventions

Trade Name: Forxiga Product Name: Dapagliflozin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: DAPAGLIFLOZIN PROPANEDIOL CAS Number: 960404-48-02 Other descriptive name: DAPAGLIFLOZIN PR

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2000

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine if dapagliflozin is superior to placebo in reducing the incidence of the primary composite endpoint of =50% sustained decline in estimated glomerular filtration rate (eGFR), reaching end stage renal disease (ESRD), CV or renal death when added to current background therapy in patients with eGFR =25 and =75 mL/min/1.73m2 and albuminuria (urine albumin creatinine ratio [UACR] =200 and =5000 mg/g);Secondary Objective: 1) To determine whether dapagliflozin compared with placebo will result in a reduction of the incidence of the composite endpoints of worsening of renal function 2) To determine whether dapagliflozin compared with placebo will result in a reduction of the incidence of the composite endpoint of CV death or hospitalization for heart failure 3) To determine whether dapagliflozin compared with placebo will result in a reduction of the incidence of all-cause mortality 4) Safety Objective: To evaluate the safety and tolerability of dapagliflozin in this patient population;Primary end point(s): Time to the first occurrence of any of the components of this composite: 1. =50% sustained decline in eGFR 2. Reaching ESRD ? - Sustained eGFR <15 mL/min/1.73m2 or, ? - Chronic dialysis treatment or, ? - Receiving a renal transplant 3. CV death 4. Renal death ;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated when at least 681 primary events has been confirmed.	—

Measure

Time frame

Main Objective: To determine if dapagliflozin is superior to placebo in reducing the incidence of the primary composite endpoint of =50% sustained decline in estimated glomerular filtration rate (eGFR), reaching end stage renal disease (ESRD), CV or renal death when added to current background therapy in patients with eGFR =25 and =75 mL/min/1.73m2 and albuminuria (urine albumin creatinine ratio [UACR] =200 and =5000 mg/g);Secondary Objective: 1) To determine whether dapagliflozin compared with placebo will result in a reduction of the incidence of the composite endpoints of worsening of renal function 2) To determine whether dapagliflozin compared with placebo will result in a reduction of the incidence of the composite endpoint of CV death or hospitalization for heart failure 3) To determine whether dapagliflozin compared with placebo will result in a reduction of the incidence of all-cause mortality 4) Safety Objective: To evaluate the safety and tolerability of dapagliflozin in this patient population;Primary end point(s): Time to the first occurrence of any of the components of this composite: 1. =50% sustained decline in eGFR 2. Reaching ESRD ? - Sustained eGFR <15 mL/min/1.73m2 or, ? - Chronic dialysis treatment or, ? - Receiving a renal transplant 3. CV death 4. Renal death ;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated when at least 681 primary events has been confirmed.

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Secondary

Measure	Time frame
Secondary end point(s): 1) Time to the first occurrence of any of the components of this composite: 1. =50% sustained decline in eGFR 2. Reaching ESRD 3. Renal death 2) Time to the first occurrence of either of the components of this composite: 1. CV death 2. Hospitalization for heart failure 3) Time to death from any cause 4) Safety endpoints: 1. Serious adverse event (SAE) 2. Discontinuation of investigational product (IP) due to adverse event (DAE)s 3. Changes in clinical chemistry/haematology parameters 4. AEs of interest (volume depletion, renal events, major hypoglycaemic events, fractures, diabetic ketoacidosis (DKA) and AEs leading to amputation and AEs leading to risk for lower limb amputations ["preceding events"]).;Timepoint(s) of evaluation of this end point: Secondary endpoints will only be evaluated once – and that is when the study stops, when at least 681 primary events has been confirmed.	—

Measure

Time frame

Secondary end point(s): 1) Time to the first occurrence of any of the components of this composite: 1. =50% sustained decline in eGFR 2. Reaching ESRD 3. Renal death 2) Time to the first occurrence of either of the components of this composite: 1. CV death 2. Hospitalization for heart failure 3) Time to death from any cause 4) Safety endpoints: 1. Serious adverse event (SAE) 2. Discontinuation of investigational product (IP) due to adverse event (DAE)s 3. Changes in clinical chemistry/haematology parameters 4. AEs of interest (volume depletion, renal events, major hypoglycaemic events, fractures, diabetic ketoacidosis (DKA) and AEs leading to amputation and AEs leading to risk for lower limb amputations ["preceding events"]).;Timepoint(s) of evaluation of this end point: Secondary endpoints will only be evaluated once – and that is when the study stops, when at least 681 primary events has been confirmed.

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Countries

Argentina, Brazil, Canada, China, Denmark, Germany, Hungary, India, Korea, Republic of, Mexico, Peru, Philippines, Poland, Russian Federation, Spain, Sweden, Ukraine, United Kingdom, United States, Vietnam

Contacts

Public ContactInformation center

AstraZeneca

information.center@astrazeneca.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026