A prospective, double-blind placebo-controlled multicentre trial to assess mycophenolic acid area under curve following Mycophenolate Mofetil and Enteric-coated Mycophenolic Acid in the presence and absence of the proton-pump inhibitor Pantoprazole in kidney and liver transplant recipients

Health Department of Western Australia0 个研究点目标入组 42 人开始时间: 2011年3月24日最近更新: 2020年1月13日

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•Inclusion Criteria:
•1.Males and females >18 years.
•2.Kidney and liver transplant recipients of deceased-donor organs or for renal only, living donor organs. Recipients must be at least 6 months post-transplant.
•3.Recipients who are willing to change to pantoprazole (from other proton-pump inhibitor or H2-antagonist) or willing to start pantoprazole if not already on this drug.
•4.Maintained on either cyclosporine or tacrolimus.
•5.Capable of giving written informed consent and adhering to the study schedule.

•Exclusion Criteria:
•1.Recipients who are unwilling to change to pantoprazole (from other proton-pump inhibitor or H2-antagonist) or unwilling to start pantoprazole if not already on this.
•2.Patients maintained on everolimus, sirolimus or other non-calcineurin inhibitor except corticosteroids.
•3.Recent change (<2 weeks) in dose of mycophenolate mofetil or enteric coated-mycophenolic sodium (EC-MPS).
•4.Recent substantial change (>50% change in dosage within 2 weeks prior to inclusion) in dose of calcineurin-inhibitor (CNI).
•5.Recent acute rejection requiring methylprednisolone within 1 month prior to inclusion.
•6.Change in dose of corticosteroids (prednisolone) within 2 weeks prior to inclusion.
•7.MDRD derived estimated glomerular filtration rate (eGFR) <30mL/min or alanine amino-transaminase (ALT) >3x upper limit of normal (ULN) or aspartate amino-transferase (AST) >3xULN or bilirubin >2xULN.
•8.Plan change in dosing of MMF or EC-MPS or CNI during study period.
•9.Significant peptic ulcer disease or ulcerative oesophagitis where withdrawal of current acid suppression therapy is not clinically appropriate.
•10.Concurrent use of magnesium and aluminium antacid or cholestyramine.

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