A non-randomized trial of conversion from ciclosporin and tacrolimus to tacrolimus MR4 in stable long-term kidney transplant recipients: Graft function and influences of ABCB1 genotypes

摘要: In this non-randomized extension study of a randomized controlled trial we converted 87 stable long-term kidney transplant recipients (KTR) from either ciclosporin (CSA, n = 28) or tacrolimus (TAC, 59) to TAC modified release (TAC MR4) the characteristics trough levels after conversion with primary endpoint graft function 12 months. MR4 consumption was calculated by level-to-dose ([ng/mL]/[mg/d]) and concentration-to-dose ([mg/kg])/d) ratios. Influences ABCB1 single nucleotide polymorphisms (2677G>T/A, 1236C>T, 3435C>T) on metabolism were studied. Graft KTR CSA significantly declined over months, remained unchanged MR4. Conversion resulted in supra therapeutic- low levels. We could not find associations genotypes Adverse events errors TAC/TAC intake common. is feasible. For suggest rate 1:40 for rough estimation target doses. Trial registration PEP Study: Ethics committee N° 393/2004, EudraCT 2004-004209-98. PEP-X amendment application 154/01/2008. ClinicalTrials.gov NCT03751332.