SGLT2i Safety and Efficacy on Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients

NCT07143773 | Recruiting Phase 4 DMC

• 1 other identifier: EU CT:2024-518773-33-00
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial investigates whether 18 months of daily SGLT2i (10 mg Forxiga) preserves kidney function and evaluates safety, based on eGFR changes and adverse event occurrence in non-diabetic kidney transplant recipients. The main questions it aims to answer are:

• Does SGLT2i versus placebo, as an add-on to standard care, preserve kidney transplant function in non-diabetic recipients?
• Is SGLT2i treatment safe for non-diabetic transplant recipients when evaluating adverse events?
• Does SGLT2i versus placebo affect the occurrence of urinary tract infections, post-transplant diabetes mellitus (PTDM) and prediabetes incidence, U-ACR, as well as renal and cardiovascular parameters? Researchers will compare a daily dose of SGLT2i (10 mg Forxiga) with a placebo (a look-alike tablet with no active medicine). Kidney transplant recipients who do not have diabetes can take part if they meet the study's requirements. Participants will be randomly assigned to receive either Forxiga or placebo once daily for 18 months. All participants will have check-ups every 3 months, which will include urine tests and blood samples. Neither the participants nor the study doctors will know which treatment they are receiving.

Conditions

Kidney Transplantation Recipients; Sodium-Glucose Transporter 2 Inhibitors; Non-Diabetic Patients; Randomized Controlled Trial; Placebo Control Design

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Kidney transplant function

  Chronic eGFR slope (ml/min/1.73m2)

  Measured from week 4, and then every 3. month until 18. month post randomization.

Secondary Outcomes (1)

• Incidence of PTDM and prediabetes status

  Measured from week 4, and then every 3. month until 18. month post randomization.

Other Outcomes (1)

• Proteinuria

  Measured from week 4, and then every 3 month until 18 month post randomization.

Study Arms (2)

SGLT2i

ACTIVE COMPARATOR

Daily dose of SGLT2i (Forxiga 10 mg tablet)

Drug: SGLT-2 inhibitor

Placebo

PLACEBO COMPARATOR

Daily dose of placebo tablet

Drug: Placebo

Interventions

SGLT-2 inhibitor 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 88 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.

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 88 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
• \> 6 months post-transplant
• eGFR\> 25 ml/min/1.73m2 within the last 3 months pre randomization
• Immunosuppressive must include Tacrolimus
• Negative plasma hCG in fertile women\*, and acceptance of the use of contraception during the course of the study.

You may not qualify if:

• Patients 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
• Breastfeeding
• Known allergy towards SGLT2i or the content substance
• Known intestinal bowel disease

Sponsors & Collaborators

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

Study Sites (1)

Department of Nephrology, Odense University Hospital Kløvervænget 6, Enterance 93, 2. floor

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

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

Lotte B Lange, MD

CONTACT

+4540863392; lotte.borg.lange@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: July 30, 2025
• First Posted: August 27, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 27, 2025

Record last verified: 2025-07

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, which is estimated for summer 2027 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. Access Mechanism: 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 (1)