Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Authorised, recruitment pending
Participants planned
260
Countries
1
Sites
2
Chronic kidney disease
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.
Key facts
- Sponsor
- Gentofte Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2024-10-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517040-65-02
- EudraCT number
- 2021-000995-13
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
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.
Conditions and MedDRA coding
Chronic kidney disease
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-517040-65-00 | 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) | Gentofte Hospital |
| 2024-517040-65-01 | 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) | Gentofte Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- - 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
Exclusion criteria 11
- Type 1 diabetes
- 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)
- • 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change in LV mass index assessed by echocardiography at 6 months
Secondary endpoints 11
- Change in LV ejection fraction at 6 months
- Change in global longitudinal strain at 6 months
- Change in LV end-diastolic volume at 6 months
- Change in LV end-systolic volume at 6 months
- Change in left atrial volume index at 6 months
- Change in creatinine/eGFR at 6 months
- Change in UACR at 6 months
- Change in haemoglobin at 6 months
- Change in proBNP at 6 months
- Change in Troponin at 6 months
- Change in LV mass at 6 months
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP100377942 · ATC
- Active substance
- Dapagliflozin Propanediol
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- A10BK01 — DAPAGLIFLOZIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Gentofte Hospital
- Sponsor organisation
- Gentofte Hospital
- Address
- Kildegaardsvej 28
- City
- Hellerup
- Postcode
- 2900
- Country
- Denmark
Scientific contact point
- Organisation
- Gentofte Hospital
- Contact name
- Katja Vu Bartholdy
Public contact point
- Organisation
- Gentofte Hospital
- Contact name
- Katja Vu Bartholdy
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| GCP-enheden ved Københavns Universitetshospital ORL-000010164
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 260 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D2_Protocol modification nr 1 2024-517040-65-02 | 10 |
| Protocol (for publication) | D2_Protocol modification nr 1 2024-517040-65-02tracked | 10 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Informed consent form | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Informed consent form_main | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Subject information | 5 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Subject information (non-dialysis) | 3 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-07 | Denmark | Acceptable 2024-10-11
|
2024-10-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-03 | Denmark | Acceptable 2025-01-28
|
2025-01-29 |