Authorised Therapeutic exploratory (Phase II) Kidney transplant recipients

The SGL-TX-PTDM study

EU CTIS ID: 2024-518774-14-00

What this study is testing

Determine the effect of oral SGLT2i compared with placebo as add-on to standard-of-care on PTDM incidence in non-diabetic KTR.

  • Therapeutic exploratory (Phase II)

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
  • • eGFR> 25 ml/min/1.73m2 within the last 3 months pre randomization
  • • Immunosuppressive must include Tacrolimus

You likely can't join 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
See the full eligibility criteria
Who can join
  • • Obtained written informed consent
  • • Male or female patients, age ≥ 18 years.
  • • Non-diabetic Kidney Transplant Recipient
  • • eGFR> 25 ml/min/1.73m2 within the last 3 months pre randomization
  • • Immunosuppressive must include Tacrolimus
What rules you out
  • • 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.

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.