Authorised Therapeutic confirmatory (Phase III) renal transplant

PRODIG : Prevention of new onset diabetes after transplantation by a short term treatment of Vildagliptin in the early post-transplant period

EU CTIS ID: 2024-516272-14-00

What this study is testing

to demonstrate that a short term treatment of vildagliptin administered in the early post-transplant period prevents the occurrence of post-transplant diabetes one year after kidney transplantation.

  • Therapeutic confirmatory (Phase III)

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

  • Patient receiving a first kidney transplant
  • Patients considered at high risk of developing posttransplant diabetes having at least 2 of the 3 following criteria: Age> 50 years; BMI greater than 30 kg/m²; Direct Family history of type 2 diabetes
  • Patients who can receive immunosuppressive therapy including tacrolimus, mycophenolic acid and steroids
  • Patients in whom the cessation of steroids may be considered at the latest at Month 3 post-transplant

You likely can't join if

  • Hepatic insufficiency
  • Patient with Class IV NYHA Heart Failure
  • Patient with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome
  • Active infection
  • Infection with Hepatitis C virus
  • Multi-Organ Transplantation
See the full eligibility criteria
Who can join
  • Patient receiving a first kidney transplant
  • Patients considered at high risk of developing posttransplant diabetes having at least 2 of the 3 following criteria: Age> 50 years; BMI greater than 30 kg/m²; Direct Family history of type 2 diabetes
  • Patients who can receive immunosuppressive therapy including tacrolimus, mycophenolic acid and steroids
  • Patients in whom the cessation of steroids may be considered at the latest at Month 3 post-transplant
What rules you out
  • Hepatic insufficiency
  • Patient with Class IV NYHA Heart Failure
  • Patient with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome
  • Active infection
  • Infection with Hepatitis C virus
  • Multi-Organ Transplantation
  • A history of diabetes / pancreatitis /angioedema

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.