Vildagliptin for Kidney transplantation|Post-transplant diabetes mellitus

Inclusion criteria

• {"criterion_text":"- Patient receiving a first kidney transplant\n- 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\n- Patients who can receive immunosuppressive therapy including tacrolimus, mycophenolic acid and steroids\n- Patients in whom the cessation of steroids may be considered at the latest at Month 3 post-transplant"}

Exclusion criteria

• {"criterion_text":"- Hepatic insufficiency\n- Patient with Class IV NYHA Heart Failure\n- Patient with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome\n- Active infection\n- Infection with Hepatitis C virus\n- Multi-Organ Transplantation\n- A history of diabetes / pancreatitis /angioedema"}

Primary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Defined as one of the following: Patients receiving a diabetic treatment; Patients have a fasting glucose above 7 mmol/l; Patients with an abnormal oral glucose tolerance test (OGTT). Measured at 1 year after transplantation."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"HbA1c and listed laboratory tests measured at 3, 6 and 12 months after transplantation."}
• {"endpoint_text":"- The occurrence of acute rejection, infection, graft loss and patient death 3 months, 6 months and 12 months after transplantation,","definition_or_measurement_approach":"Occurrence of acute rejection, infection, graft loss, and patient death assessed at 3, 6 and 12 months post-transplant."}
• {"endpoint_text":"- The health related quality of life (ReTRANSQOL questionnaire) 8 days, 3 months, 6 months and 12 months after transplantation compared to the baseline,","definition_or_measurement_approach":"Health-related quality of life measured by ReTRANSQOL questionnaire at baseline, 8 days, 3, 6 and 12 months after transplantation."}
• {"endpoint_text":"- The cost of the care and treatment up to one year after transplantation.","definition_or_measurement_approach":"Economic evaluation: cost of care and treatment up to one year after transplantation."}

France

Earliest CTIS Part Ii Submission Date

08-08-2024

Latest Decision Or Authorization Date

16-01-2025

Processing Time Days

161

Number Of Sites

9

Number Of Participants

186

Primary sponsor

Full Name

Centre Hospitalier Regional Universitaire

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France