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SGL-TX-GFR SGLT2i safety and efficacy on kidney allograft function in non-diabetic kidney transplant recipients: A randomized, double-blind, placebo controlled, national, multicenter trial.
EU CTIS ID: 2024-518773-33-00
What this study is testing
In this non-inferior randomized controlled clinical trial we determine the safety and efficacy of oral SGLT2i compared with placebo as add-on to standard-of-care on affecting kidney transplant function (eGFR) in non-diabetic kidney transplant recipients.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Obtained written informed consent
- Male or female patients, age ≥ 18 years
- Non-diabetic Kidney Transplant Recipient
- > 6 months post-transplant
- eGFR> 25 ml/min/1.73m2 within the last 3 months pre randomization
- Immunosuppressive must include Tacrolimus
You likely can't join 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
See the full eligibility criteria
- Obtained written informed consent
- Male or female patients, age ≥ 18 years
- Non-diabetic Kidney Transplant Recipient
- > 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.
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.