NCT05359263

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
222

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 8, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2025

Completed
Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

2.7 years

First QC Date

April 28, 2022

Last Update Submit

February 6, 2025

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

  • Change in LV mass index assessed by echocardiography at 6 months

    6 months

Secondary Outcomes (11)

  • Change in LVEF assessed by echocardiography at 6 months

    6 months

  • Change in LA volume index assessed by echocardiography at 6 months

    6 months

  • Change in GLS assessed by echocardiography at 6 months

    6 months

  • Change in high sensitivity troponin I (hs-TNI) at 6 months

    6 months

  • Change in N-terminal pro B-type natriuretic peptide (NT-pro-BNP) at 6 months

    6 months

  • +6 more secondary outcomes

Study Arms (2)

Dapagliflozin 10 mg once daily

EXPERIMENTAL
Drug: Dapagliflozin 10 mg

Placebo once daily

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Dapagliflozin 10 mgDRUG

The intervention arm consists of dapagliflozin 10 mg orally once daily

Dapagliflozin 10 mg once daily
PlaceboDRUG

The comparator arm consists of placebo orally once daily

Placebo once daily

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gentofte Hospital

Copenhagen, 2900, Denmark

RECRUITING

Related Publications (3)

  • 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.

    PMID: 41147829DERIVED

  • Natale 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.

    PMID: 38770818DERIVED

  • Bartholdy 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.

    PMID: 36649484DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tor Biering-Sørensen

    Research Director

    STUDY CHAIR

Central Study Contacts

Katja Vu Bartholdy, MD

CONTACT

+4531360232katja.vu.bartholdy@regionh.dk

Niklas Dyrby Johansen

CONTACT

+4520204794niklas.dyrby.johansen@regionh.dk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Director, MD, PhD, MPH

Study Record Dates

First Submitted

April 28, 2022

First Posted

May 3, 2022

Study Start

June 8, 2022

Primary Completion

February 18, 2025

Study Completion

February 18, 2025

Last Updated

February 10, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Locations

DK(1)