CompletedPhase 4

Trial of Steroid Avoidance and Low-dose CNI by ATG-induction in Renal Transplantation

Sweden224 participantsStarted 2013-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Cumulative incidence of New Onset of Diabetes After Transplantation(NODAT)

Timeframe: 12 month after transplantation

Trial details

NCT IDNCT02083991

SponsorVastra Gotaland Region

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2017-01