Clinical trial NCT02083991: Trial of Steroid Avoidance and Low-dose CNI by ATG-induction in Renal Transplantation
Official title: A Controlled Randomized, Open-label, Multi-centre Study Evaluating if a Steroid-free Immunosuppressive Protocol, Based ATG-induction, Low Tacrolimus-dose and Therapeutic Drug Monitoring of Mycophenolate Mofetil, Reduces the Incidence of New Onset Diabetes After Transplantations, in Comparison With Standard Steroid-based Protocol With Low-dose Tacrolimus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: NODAT
Renal transplantation
Corticosteroids avoidance
CNI minimization
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2014-03-11
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative incidence of New Onset of Diabetes After Transplantation(NODAT)
timeFrame: 12 month after transplantation
Secondary outcomes:
measure: Cumulative incidence of NODAT
timeFrame: 3, 6, 24 month after transplantation
measure: Composite measure
timeFrame: 12, 24 months
measure: Renal function
timeFrame: 12, 24 months
measure: Incidence of acute rejection and chronic changes
timeFrame: 12 months
measure: Incidence of hypertension
timeFrame: 3, 12, 24 months
measure: Antihypertensive treatment
timeFrame: 3, 12, 24 months
measure: Lipid lowering drugs
timeFrame: 12, 24 months
measure: Incidence of antibody-mediated rejection
timeFrame: 12, 24 months
measure: Cumulative frequency of cardiovascular complications and events.
timeFrame: 10 days, 3, 12, 24 months
measure: Cumulative frequency of malignancy.
timeFrame: 6, 12, 24 months
measure: Cumulative frequency of infections
timeFrame: 10 days, 3, 6, 12, 24 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Transplant Institute, Sahlgrenska University Hospital
Study officials:
affiliation: Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden
name: Per Lindnér, MD
role: PRINCIPAL_INVESTIGATOR
References: