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

Phase 1

Conditions: renal transplant
MedDRA version: 20.0Level: SOCClassification code: 10038359Term: Renal and urinary disorders Class: 18
Therapeutic area: Phenomena and Processes [G] - Metabolism [G03]

Registration Number: CTIS2024-516272-14-00

Lead Sponsor: Centre Hospitalier Regional Universitaire

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 186

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: to determine the effect of vildaglipin administration on glycemic control (glycosylated hemoglobin) at 3, 6 and 12 months after transplantation, the occurrence of acute rejection and infections 1 year after transplantation, correlation with the health-related quality of life (ReTRANSQOL questionnaire), 8 days, 3 months, 6 months and 12 months after transplantation., the cost-effectiveness ratio will be analyzed in both groups of patients.;Primary end point(s): the proportion of diabetic patients 1 year after transplantation, defined as one of the following proposals: - Patients receiving a diabetic treatment - Patients have a fasting glucose above 7 mmol/l - Patients with an abnormal oral glucose tolerance test (OGTT)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):The glycated hemoglobin (HbA1c) 3 months, 6 months and 12 months after transplantation and Laboratory tests (creatinine, creatinine clearance, uric acid, CRP, lipid profile, blood sugar, liver and pancreas balance, blood count) 3 months, 6 months and 12 months after transplantation;Secondary end point(s):The occurrence of acute rejection, infection, graft loss and patient death 3 months, 6 months and 12 months after transplantation,;Secondary end point(s):The health related quality of life (ReTRANSQOL questionnaire) 8 days, 3 months, 6 months and 12 months after transplantation compared to the baseline,;Secondary end point(s):The cost of the care and treatment up to one year after transplantation.