Chronic Kidney DiseasesPhase 2DECODE-CKDNCT05359263
Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with CKD
A Phase 2 study testing Dapagliflozin 10 mg in people with Chronic Kidney Diseases, run by Tor Biering-Sørensen at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the effects of dapagliflozin on echocardiographic measures of cardiac structure and function in patients with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Dapagliflozin 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Jun 2022to 18 Feb 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- ≥ 18 years of age
- Chronic kidney disease (CKD), defined as evidence of decreased eGFR (eGFR ≥20 and <60 mL/minute per 1.73 m2) or between eGFR ≥60 and <90 mL/minute per 1.73 m2 with urinary albumin:creatinine ratio ≥200 mg/g or protein:creatinine ratio ≥300 mg/g
- Stable treatment with clinically appropriate doses of ACEi/ARB among CKD patients with proteinuria and uptitrated to maximal recommended or tolerated dose for at least 4 weeks before randomization, if not medically contraindicated
- For patients with type 2 diabetes:
- 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 join
- Type 1 diabetes
- For patients with type 2 diabetes:
- History of diabetic ketoacidosis
- Patients undergoing dialysis
- History of organ transplant
- Treatment with SGLT2 inhibitor within 8 weeks prior to enrolment
Show all 15Show fewer
- 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
- 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)
- 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.
- Female patients who are pregnant, lactating, or are considering becoming pregnant during the study or for 6 months after study completion
- Participation in another clinical study with an investigational product within the last month prior to enrolment
- Inability to understand or comply with the investigational product, procedures, and/or follow-up or any conditions that may prevent the participant to complete the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Gentofte Hospital
Copenhagen, 2900
Katja Vu Bartholdy, MD
About this study
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
The purpose of this study is to investigate the effects of dapagliflozin on echocardiographic measures of cardiac structure and function in patients with chronic kidney disease.
Read the detailed description
The study is a 6-month, investigator-initiated, randomized, double-blind, placebo-controlled clinical trial to evaluate the effects of dapagliflozin on echocardiographic measures of cardiac structure and function in patients with chronic kidney disease. The study population will consist of approximately 222 adults with chronic kidney disease - defined as a glomerular filtration rate (GFR) of 20-60 mL/min/1.73m2, in treatment with maximally tolerated ACEi or ARB. Patients will be randomized to either 10 mg dapagliflozin or placebo. Patients will be assessed by measurement of echocardiography, pulse wave velocity, blood samples, urine samples, quality of life, depressive symptoms, and cognitive function at baseline and after 6 months of treatment.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Dapagliflozin 10 mg, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 mgDrug
The intervention arm consists of dapagliflozin 10 mg orally once daily
PlaceboDrug
The comparator arm consists of placebo orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin 10 mg once daily | Experimental | Not described Receives: Drug: Dapagliflozin 10 mg |
| Placebo once daily | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LV mass index assessed by echocardiography at 6 months
Measured: 6 months
Secondary outcomes (11)
Change in LVEF assessed by echocardiography at 6 months
Measured: 6 months
Change in LA volume index assessed by echocardiography at 6 months
Measured: 6 months
Change in GLS assessed by echocardiography at 6 months
Measured: 6 months
Change in high sensitivity troponin I (hs-TNI) at 6 months
Measured: 6 months
Change in N-terminal pro B-type natriuretic peptide (NT-pro-BNP) at 6 months
Measured: 6 months
Change in estimated glomerular filtration rate (eGFR) 6 months
Measured: 6 months
Change in urinary albumin-to-creatinine ratio (UACR) at 6 months
Measured: 6 months
Change in hemoglobin at 6 months
Measured: 6 months
Change in LV mass assessed by echocardiography at 6 months
Measured: 6 months
Change in LV end-diastolic volume at 6 months
Measured: 6 months
Change in LV end-systolic volume at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start8 Jun 2022
- Primary completion18 Feb 2025 (estimated)
- Study completion18 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tor Biering-Sørensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tor Biering-Sørensen, Herlev and Gentofte Hospital
- Investigators
- Tor Biering-Sørensen, Study chair, Research Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359263
- Sponsor's protocol ID
- DECODE-CKD
- Acronym
- DECODE-CKD
- Status last verified
- Feb 2025
- First submitted
- 28 Apr 2022
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Bartholdy KV, Johansen ND, Skaarup KG, Modin D, Landler N, Langhoff AF, Ottosen CI, Espersen C, Dons M, Borchsenius JIM, Davodian LW, Lassen MH, Davidovski FS, Jensen AMR, Sengelov M, Christensen J, Schou M, Feldt-Rasmussen B, Jensen J, Bressendorff I, Persson F, Rossing P, Kober L, Zannad F, Vaduganathan M, Solomon S, Haynes R, Hansen D, Biering-Sorensen T. Cardiac Effects of Dapagliflozin in People with Chronic Kidney Disease. NEJM Evid. 2025 Nov;4(11):EVIDoa2500158. doi: 10.1056/EVIDoa2500158. Epub 2025 Oct 28.
PubMed 41147829Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PubMed 38770818Bartholdy KV, Johansen ND, Landler N, Skaarup KG, Jensen J, Bressendorff I, Schou M, Christensen J, Feldt-Rasmussen B, Vaduganathan M, Solomon S, Haynes R, Persson F, Rossing P, Kober L, Zannad F, Hansen D, Biering-Sorensen T. Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with Chronic Kidney Disease: The DECODE-CKD Trial. Kidney360. 2023 Feb 1;4(2):143-149. doi: 10.34067/KID.0006982022. Epub 2022 Dec 18.
PubMed 36649484
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05359263
- Acronym / sponsor ID
- DECODE-CKD / DECODE-CKD
- Conditions
- Chronic Kidney Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Tor Biering-SørensenUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 18 Feb 2025 (estimated)
- Study completion
- 18 Feb 2025 (estimated)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effects of dapagliflozin on echocardiographic measures of cardiac structure and function in patients with chronic kidney disease.
Detailed description
The study is a 6-month, investigator-initiated, randomized, double-blind, placebo-controlled clinical trial to evaluate the effects of dapagliflozin on echocardiographic measures of cardiac structure and function in patients with chronic kidney disease. The study population will consist of approximately 222 adults with chronic kidney disease - defined as a glomerular filtration rate (GFR) of 20-60 mL/min/1.73m2, in treatment with maximally tolerated ACEi or ARB. Patients will be randomized to either 10 mg dapagliflozin or placebo. Patients will be assessed by measurement of echocardiography, pulse wave velocity, blood samples, urine samples, quality of life, depressive symptoms, and cognitive function at baseline and after 6 months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin 10 mg once daily | Experimental | Drug: Dapagliflozin 10 mg |
| Placebo once daily | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent
- ≥ 18 years of age
- Chronic kidney disease (CKD), defined as evidence of decreased eGFR (eGFR ≥20 and <60 mL/minute per 1.73 m2) or between eGFR ≥60 and <90 mL/minute per 1.73 m2 with urinary albumin:creatinine ratio ≥200 mg/g or protein:creatinine ratio ≥300 mg/g
- Stable treatment with clinically appropriate doses of ACEi/ARB among CKD patients with proteinuria and uptitrated to maximal recommended or tolerated dose for at least 4 weeks before randomization, if not medically contraindicated
- For patients with type 2 diabetes:
Key exclusion criteria (15 listed)
- Type 1 diabetes
- For patients with type 2 diabetes:
- History of diabetic ketoacidosis
- Patients undergoing dialysis
- History of organ transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10 mgThe intervention arm consists of dapagliflozin 10 mg orally once daily | Drug | Dapagliflozin 10 mg once daily |
| PlaceboThe comparator arm consists of placebo orally once daily | Drug | Placebo once daily |
Primary outcome
Change in LV mass index assessed by echocardiography at 6 months
Time frame: 6 months
11 secondary outcomes
Change in LVEF assessed by echocardiography at 6 months
Time frame: 6 months
Change in LA volume index assessed by echocardiography at 6 months
Time frame: 6 months
Change in GLS assessed by echocardiography at 6 months
Time frame: 6 months
Change in high sensitivity troponin I (hs-TNI) at 6 months
Time frame: 6 months
Change in N-terminal pro B-type natriuretic peptide (NT-pro-BNP) at 6 months
Time frame: 6 months
Change in estimated glomerular filtration rate (eGFR) 6 months
Time frame: 6 months
Change in urinary albumin-to-creatinine ratio (UACR) at 6 months
Time frame: 6 months
Change in hemoglobin at 6 months
Time frame: 6 months
Change in LV mass assessed by echocardiography at 6 months
Time frame: 6 months
Change in LV end-diastolic volume at 6 months
Time frame: 6 months
Change in LV end-systolic volume at 6 months
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Derived from this study: PubMed 41147829Bartholdy KV, Johansen ND, Skaarup KG, Modin D, Landler N, Langhoff AF, Ottosen CI, Espersen C, Dons M, Borchsenius JIM, Davodian LW, Lassen MH, Davidovski FS, Jensen AMR, Sengelov M, Christensen J, Schou M, Feldt-Rasmussen B, Jensen J, Bressendorff I, Persson F, Rossing P, Kober L, Zannad F, Vaduganathan M, Solomon S, Haynes R, Hansen D, Biering-Sorensen T. Cardiac Effects of Dapagliflozin in People with Chronic Kidney Disease. NEJM Evid. 2025 Nov;4(11):EVIDoa2500158. doi: 10.1056/EVIDoa2500158. Epub 2025 Oct 28.
- Derived from this study: PubMed 38770818Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
- Derived from this study: PubMed 36649484Bartholdy KV, Johansen ND, Landler N, Skaarup KG, Jensen J, Bressendorff I, Schou M, Christensen J, Feldt-Rasmussen B, Vaduganathan M, Solomon S, Haynes R, Persson F, Rossing P, Kober L, Zannad F, Hansen D, Biering-Sorensen T. Effects of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with Chronic Kidney Disease: The DECODE-CKD Trial. Kidney360. 2023 Feb 1;4(2):143-149. doi: 10.34067/KID.0006982022. Epub 2022 Dec 18.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tor Biering-Sørensen study chair
Research Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin 10 mg in people with Chronic Kidney Diseases, run by Tor Biering-Sørensen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katja Vu Bartholdy, MD (+4531360232, katja.vu.bartholdy@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LV mass index assessed by echocardiography at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05359263, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.