SGLT2i Safety and Efficacy on Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients: A Randomized, Double-blind, Placebo Controlled, National, Multicenter Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Department of Nephrology, Odense University Hospital Kløvervænget 6, Enterance 93, 2. floor
RECRUITING
Odense
Contact Information
Primary
Lotte B Lange, MD
lotte.borg.lange@rsyd.dk
+45 40863392
Backup
Lotte B Lange, MD
lotte.borg.lange@rsyd.dk
+4540863392
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 88
Treatments
Active_comparator: SGLT2i
Daily dose of SGLT2i (Forxiga 10 mg tablet)
Placebo_comparator: Placebo
Daily dose of placebo tablet
Sponsors
Leads: Odense University Hospital
Collaborators: Gødstrup Hospital, Copenhagen University Hospital, Denmark, Aarhus University Hospital

This content was sourced from clinicaltrials.gov