Prophylaxis of rejection in kidney allograft recipients (by immunosuppression) MedDRA version: 14.1 Level: LLT Classification code 10050436 Term: Prophylaxis against renal transplant rejection System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Thymoglobuline
Product Name: Thymoglobuline
Pharmaceutical Form: Powder for concentrate for solution for infusion
Trade Name: Simulect
Product Name: Simulect
Pharmaceutical Form: Powder a
Sponsors
Transplant Institute, Sahlgrenska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients receiving a first or second single kidney transplant from a deceased or a living donor. 2. Female or male aged above 18 years 3. Patients considered for a standard immunosuppressive protocol. 4. Patients capable of giving written informed consent for participation in the study for 24 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Patients with known diabetes mellitus or plasma glucose >11.1 mmol/l at admission 2. Recipients of multiorgan transplants, and or previously transplanted with any other organ than kidney 3. Patients with CDC-PRA > 25 % in most recent test or for any other reason considered to be of a high risk for rejection which requires an enhanced immunosuppression. 4. Patients receiving a renal transplant from a HLA-identical sibling 5. Patients with hypersensitivity to, or other reasons to not be able to take the immunosuppressive drugs used in the study 6. Patients who are recipients of ABO-incompatible transplants 7. Patients who are unlikely to comply with the study requirements 8. Patients, and/or those receiving organs from donors, who are positive for HIV, Hepatitis B surface antigen or Hepatitis C virus. 9. Females of childbearing potential, who are, or are planning to be, pregnant, and/or are unwilling to use effective means of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The cumulative incidence of NODAT (new onset of diabetes after transplantation) 12 months after transplantation as defined by the ADA-criteria (2012). Arm A. Steroid-free low-TAC arm: Thymoglobuline® induction (2,5 mg/kg, pre-/peroperatively day 0, 2,5 mg/kg day 1) + Advagraf® (conc.: 5-10 ng/ml, after 3 months 4-7, started postop. day 1) + MMF 1gx2 (controlled by a single AUC measurement day 7 with a target AUC between 40 and 60 mg.h/L) + steroids day 0 (250 mg methylprednisolon iv. before start of Thymoglobuline infusion and day 1 50 mg methylprednisolon iv. before start of Thymoglobuline infusion) Arm B. Standard low-TAC arm: Simulect® induction 20mg (day 0 and day 4) + Advagraf® (conc.: 5-10 ng/ml, after 3 months 4-7ng/ml, started per hospital practice) + MMF 1gx2 (controlled by AUC measurements to 40-60 mg.h/L) + steroids according to hospital practice but not less than 5 mg prednisolone daily after 6 months.;Secondary Objective: •The cumulative incidence of NODAT •Use of antidiabetic medication •The composite measure of freedom from acute rejection (AR), graft survival, and patient survival. •The incidence of antibody-mediated rejection •Renal function •The incidence of chronic changes, analyzed by protocol biopsies •Incidence of hypertension •Number of antihypertensive drugs •Number of lipid lowering •Incidence of cardiovascular complications and events •Incidence of malignancy •Safety and tolerability;Primary end point(s): The primary endpoint of the study is the incidence of New Onset Diabetes Mellitus defined as: The cumulative incidence of NODAT (new onset of diabetes after transplantation) 12 months after transplantation as defined by the ADA-criteria (2012). Cumulative incidence of one of the following: 1. =2 FPG =7, 0 mmol/l = 30 consecutive days apart 2. 2-h Plasma Glucose =11,1 mmol/l in the OGTT= 30 consecutive days apart 3. Oral hypoglycemic =30 consecutive days 4. Insulin =30 consecutive days;Timepoint(s) of evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The cumulative incidence of NODAT (new onset of diabetes after transplantation) 3, 6 and 24 months after transplantation. - OGTT will be performed 3 and 12 months after transplantation - Use of antidiabetic medication at 6, 12 and 24 months. - Acute rejection at 6, 12 and 24 months - The composite measure of freedom from acute rejection (AR), graft survival, and patient survival at 12 and 24 months after transplantation. - Renal function at 12 and 24 months - Incidence of chronic allograft nephropathy (CAN) at 12 months - Incidence of patients with hypertension at 12 and 24 months. - Number of antihypertensive drugs at 12 and 24 months - Number of lipid lowering drugs at 12 and 24 months - Incidence of cardiovascular complications and events - Incidence of malignancy - Safety and tolerability;Timepoint(s) of evaluation of this end point: Please see above, different timepoints for different endpoints. | — |
Countries
Denmark, Sweden
Contacts
Public ContactStudycoordinator
Transplant Institute, Sahlgrenska University Hospital
Outcome results
None listed