Not yet taking people in DenmarkPhase 1/2
Tests dapagliflozin's effect on heart structure and function in chronic kidney disease
Tests dapagliflozin in adults with chronic kidney disease, checking heart structure and function.
Key facts
- Who runs it
- Gentofte Hospital
- Where
- Hellerup and Herlev, DenmarkSee the 2 sites
- Registry title
- A 6-Month, Randomized, Double-Blind Study to Evaluate the Effect of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with Chronic Kidney Disease (DECODE-CKD)
- Status
- Not yet recruiting
- Phase
- Phase 1/2
- People taking part
- 260 people, planned
- Started
- 8 Jun 2022
- Expected to end
- 1 Jan 2028
- Type of study
- Interventional
- Record updated
- 29 January 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic kidney disease (CKD), including some people on haemodialysis, to test how dapagliflozin affects the heart over 6 months.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Chronic kidney disease. Without dialysis: eGFR >=20 and <60 mL/min/1.73 m2 for at least 3 months, or albuminuria for more than 3 months if eGFR is above 60. On haemodialysis: started within 1 year before randomization.
- Earlier treatment
- People with protein in the urine need stable ACEi/ARB treatment, unless it is medically contraindicated. People with type 2 diabetes need stable blood sugar treatment for more than 30 days before screening. No SGLT2 inhibitor within 8 weeks (not on dialysis) or 4 weeks (on dialysis) before enrolment.
- Biomarker or test result
- eGFR >=20 and <60 mL/min/1.73 m2, or albuminuria for more than 3 months if eGFR is above 60 (people not on dialysis).
Main reasons for not taking part
- Type 1 diabetes
- History of organ transplant
- Known blood-borne disease such as hepatitis or HIV
- Heart attack, unstable angina, stroke or TIA within 12 weeks of enrolment
- Allergy to SGLT2 inhibitors or placebo ingredients
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Signed informed consent
- ≥ 18 years of age
- For those not undergoing dialysis: o Chronic Kidney Disease (CKD), defined as evidence of decreased eGFR (eGFR >=20 and <60 mL/min/1.73 m2) at least 3 months before and at the time of screening or evidence of albuminuria present for > 3 months if eGFR >60
- For those undergoing hemodialysis: Initiation of hemodialysis within 1 year of the randomization visit
- Stable treatment with clinically appropriate doses of ACEi/ARB among CKD patients with proteinuria, if not medically contraindicated
- For patients with type 2 diabetes: o Stable antihyperglycemic treatment > 30 days before screening
- Female patients should either not be of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of contraception throughout the study and for 30 days after study completion: Hormonal contraception (oral contraceptives, contraceptive implant, injectable birth control, contraceptive patch, or vaginal ring) or intrauterine device
- Ability to understand and read Danish
Who cannot take part
- Type 1 diabetes
- For dialysis participants: Known hepatic impairment documented in the participants electronic health record; Known blood-borne diseases, such as Hepatitis A, B, C, D, and E, and Human immunodeficiency virus (HIV) types 1 and 2, Ebola, Lassa fever virus; For patients with type 2 diabetes: o History of diabetic ketoacidosis; History of organ transplant; Treatment with SGLT2 inhibitor within 8 weeks (not undergoing dialysis) or 4 weeks (undergoing dialysis) prior to enrolment; Known allergy or hypersensitivity to SGLT2 inhibitors or Placebo ingredients; Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks of enrolment; Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment; Any condition outside the renal and cardiovascular study area with a life expectancy of <2 years based on investigator’s clinical judgement; For non-dialysis participants: Hepatic impairment (aspartate transaminase or alanine transaminase >3 times the upper limit of normal [ULN] or total bilirubin >2 times the ULN at the time of enrolment)
Where in Denmark
- Gentofte HospitalHellerup, DenmarkNot yet recruiting
- Herlev og Gentofte Hospital, Region HHerlev, DenmarkNot yet recruiting
About the trial
What the trial wants to find out
The study will provide a comprehensive view of the effect of dapagliflozin on cardiac structural changes, as well as the effect on systolic and diastolic cardiac function, in patients with all stages of CKD of different etiology.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- A 6-Month, Randomized, Double-Blind Study to Evaluate the Effect of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with Chronic Kidney Disease (DECODE-CKD)
- Plain-language title
- Tests dapagliflozin's effect on heart structure and function in chronic kidney diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 29 January 2025