2024-517040-65-02Not yet recruitingPhase 1/2
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 29 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- First submitted
- 7 Oct 2024
- Start date
- 8 Jun 2022
- Lead sponsor
- Gentofte Hospital
- Diseases
- Chronic kidney disease
- EU CT number
- 2024-517040-65-02
- EudraCT number
- 2021-000995-13
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 260
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Type 1 diabetes
Lab values
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gentofte Hospital | Hellerup | Denmark | Not yet recruiting |
| Herlev og Gentofte Hospital, Region H | Herlev | Denmark | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.