SGLT2i Effect on PTDM Development and Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients: A Randomized, Doubleblind, Placebo Controlled, National Multicenter Trial

NCT07682350 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: EU CT:2024-518774-14-002024-518774-14-00
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to find out whether 12 months of treatment with the SGLT2 inhibitor Forxiga® (dapagliflozin 10 mg once daily), compared with placebo, can reduce the risk of developing post-transplant diabetes in kidney transplant recipients who do not have diabetes at the time of transplantation. The main questions it aims to answer are:

• Does Forxiga reduce the risk of developing post-transplant diabetes and prediabetes compared with placebo?
• Does Forxiga help preserve the function of the transplanted kidney compared with placebo?
• Is Forxiga safe for kidney transplant recipients who do not have diabetes?
• Does Forxiga affect the occurrence of urinary tract infections, the amount of protein in the urine, and other kidney- and heart-related health measures compared with placebo? Researchers will compare Forxiga with a placebo (a look-alike tablet containing no active medicine) to see whether it can reduce the risk of post-transplant diabetes while maintaining kidney function and remaining safe to use. Adults who have recently received a kidney transplant and do not have diabetes may take part if they meet the study requirements. Participants will be randomly assigned to receive either Forxiga or placebo once daily for 12 months. They will attend study visits 3, 6, and 12 months after joining the study. These visits will include health checks, blood tests, and urine tests. Neither the participants nor the study doctors will know which treatment each participant is receiving.

Conditions

Kidney Transplant Recipient; Non-Diabetic Patients; Randomized Controlled Trial (RCT); Placebo Control Design; Post Transplant Diabetes Mellitus; Sodium Glucose Co-Transporter 2 Inhibitors

Keywords

SGLT2i; Kidney Transplant; Kidney Transplant Recipients; non-diabetic patients; Sodium-glucose Transporter 2 inhibitors; RCT; SGL-TX-PTDM

Outcome Measures

Primary Outcomes (1)

• Incidence of post-transplant diabetes mellitus (PTDM)

  Domain: Post-transplant diabetes mellitus Specific measurement: Diagnosis of PTDM according to the American Diabetes Association (ADA) diagnostic criteria. Specific metric: Number of participants with PTDM Method of aggregation: Proportion of participants with PTDM in each treatment group (dapagliflozin versus placebo) Time point: 3, 6 and 12 months after randomization

  Follow up at 3,6 and 12 months after randomization

Secondary Outcomes (11)

• Prediabetes status

  Follow up at 3,6 and 12 months after randomization

• Change in kidney allograft function

  Follow up at 3,6 and 12 months after randomization

• Change in proteinuria

  Follow up at 3,6 and 12 months after randomization

• Change in biochemical parameters

  Follow up at 3,6 and 12 months after randomization

• Urinary tract infections

  Follow up at 3,6 and 12 months after randomization

Other Outcomes (1)

• Health-related quality of life

  By baseline and 12 months after randomization

Study Arms (2)

SGLT2i

ACTIVE COMPARATOR

Daily dose of SGLT2i (Forxiga 10 mg tablet)

Drug: SGLT2i

Placebo

PLACEBO COMPARATOR

Daily dose of placebo tablet

Drug: Placebo

Interventions

SGLT2i DRUG

The intervention in this clinical trial will be treatment with an SGLT2 inhibitor (Forxiga, 10 mg tablet once daily) compared with a matching placebo. A total of 184 non-diabetic kidney transplant recipients will be enrolled. All participants will be randomized in a 1:1 ratio to receive either Forxiga or placebo as an add on to standard immunosuppressive therapy. This intervention differs from other studies by specifically targeting non-diabetic kidney transplant recipients, a population in which the efficacy and safety of SGLT2 inhibitors have not yet been established.

Also known as: Dapagliflozin, Forxiga 10 mg

SGLT2i

Placebo DRUG

The control intervention in this clinical trial will be a matching placebo tablet, identical in appearance to Forxiga (10 mg), administered once daily as an add on to standard immunosuppressive therapy. A total of 184 non-diabetic kidney transplant recipients will be enrolled. All participants will be randomized in a 1:1 ratio to receive either placebo or Forxiga. This placebo intervention ensures blinding of both participants and investigators and allows a direct comparison of the safety and efficacy of SGLT2 inhibition versus no active treatment in this unique patient population.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obtained written informed consent
• Male or female patients, age ≥ 18 years.
• Non-diabetic KTR
• Immunosuppressive must include Tacrolimus

You may not qualify if:

• Patients who is treated (diet or antidiabetics) for diabetes type 1 or 2 before randomization
• eGFR\< 25 ml/min/1.73m2 (before randomization)
• Alanine aminotransferase (ALAT) \> 3 x upper normal limit
• Bilirubin \> 2 x upper normal limit
• Pregnancy
• Positive plasma hCG
• Breastfeeding
• Known allergy towards SGLT2i or the content substance
• Patients with chronic intestinal diseases, including inflammatory bowel diseases (e.g., Crohn's disease and ulcerative colitis) and structural conditions such as short bowel syndrome.

Sponsors & Collaborators

• Odense University Hospital: lead
• Aarhus University Hospital: collaborator
• Copenhagen University Hospital, Denmark: collaborator

Study Sites (3)

Department of Renal Medicine

Aarhus, 8200, Denmark

Location

Department of Nephrology and Endocrinology.

Copenhagen, 2100, Denmark

Location

Department of Nephrology, Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Interventions

dapagliflozin

Study Officials

• Lotte B Lange, MD

  Department of Nephrology, Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lotte B Lange, MD

CONTACT

+45 40863392; lotte.borg.lange@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, double-blind, placebo controlled, national, multicenter trial

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: July 2, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will be available after the last patients last visit. Data Storage: The data will be stored for 25 years on a secure third-party platform (OPEN).
• Access Criteria: Criteria for Access: Data will be shared with researchers who submit a methodologically sound proposal aimed at achieving the goals outlined in their approved research proposal. Interested researchers should direct their proposals to: lotte.borg.lange@rsyd.dk. To gain access, requestors will be required to sign a data access agreement.

Locations

DK (3)