Diabetes Mellitus
Conditions
Keywords
NODAT, Renal transplantation, Corticosteroids avoidance, CNI minimization
Brief summary
Balancing immunosuppressive treatment in organ transplantation in order to achieve effective prevention of rejection on one side and avoidance of negative side effects on the other side is a major challenge, leading to developing different immunosuppressive protocols. Cornerstones of immunosuppressive treatment such as Corticosteroids (CS) and Calcineurin Inhibitors (CNI) are known to cause an increased incidence of diabetes, cardiovascular morbidity, nephrotoxicity and malignancies. The investigators believe that both avoidance of CS and minimization of CNI, while using Anti-ThymocyteGlobuline(ATG) induction (instead of interleucin-2 receptor blockers) and mycofenolate mofetil(MMF) therapeutic drug monitoring is going to reduce negative side effects, without increased rejection frequency in renal transplanted patients.
Interventions
DRUGSteroid-free low TAC-arm: Thymoglobulin Standard low-TAC arm: Simulect, prednisolon
Sponsors
Vastra Gotaland Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* First or second single kidney (cadaveric or living donors) transplant recipients. * Considered for a standard immunosuppressive protocol. * Must be capable of giving written informed connect for participation in the study for 24 months.
Exclusion criteria
* Diabetes mellitus or plasma glucose \>11,1 at admission. * Receiving steroids at the time of transplantation or likely to need steroids after transplantation. * Multiorgan transplants and/or previously transplanted with any other organ than kidney. * Panel reacting antibodies(PRA) \>25% in most recent test or considered to be of high risk for rejection which requires an enhanced immunosuppression. * Renal transplants from HLA-identical sibling. * Hypersensitivity to, or disability to take immunosuppressive drugs. * Blood group(ABO)-incompatible transplants. * Unlikely to comply with the study requirements. * Transplant from donor positive for HIV, HBsAg, Hepatitis C. * Female of childbearing potential planing/being pregnant or unwilling to use contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative incidence of New Onset of Diabetes After Transplantation(NODAT) | 12 month after transplantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypertension | 3, 12, 24 months | Standardized measurement. |
| Antihypertensive treatment | 3, 12, 24 months | Number and type of antihypertensive drugs. |
| Lipid lowering drugs | 12, 24 months | Number and type of lipid lowering drugs. |
| Incidence of antibody-mediated rejection | 12, 24 months | Analysed by biopsies, evaluated by the Banff system, and by donor-specific HLA antibodies |
| Cumulative incidence of NODAT | 3, 6, 24 month after transplantation | — |
| Incidence of acute rejection and chronic changes | 12 months | Analysed by protocol biopsies, evaluated by the Banff system. |
| Renal function | 12, 24 months | Evaluated by measured glomerular filtration rate (mGFR) |
| Cumulative frequency of cardiovascular complications and events. | 10 days, 3, 12, 24 months | Collecting Adverse Events (AE) reports |
| Cumulative frequency of malignancy. | 6, 12, 24 months | Collecting AE reports |
| Cumulative frequency of infections | 10 days, 3, 6, 12, 24 months | Collecting AE reports |
| Composite measure | 12, 24 months | Freedom from acute rejection, graft and patient survival |
Countries
Sweden
Outcome results
None listed