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Tests treatment safety and results for Kidney Transplantation Recipients
Official title SGLT2i Safety and Efficacy on Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients
ClinicalTrials.gov ID: NCT07143773
What this study is testing
What is SGLT-2 inhibitor?
SGLT-2 inhibitor is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for kidney transplantation recipients.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
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 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.
- 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.
Where it's taking place
- Odense, Denmark
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Odense, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.