None listed
Conditions
Brief summary
To determine the effect of gastric acid suppression (using the proton pump inhibitor [PPI] pantoprazole) on the pharmacokinetics of mycophenolic acid (MPA) in kidney and liver transplant recipients maintained on either mycophenolate mofetil [MMF] or enteric-coated mycophenolate sodium [EC-MPS]. The following outcomes will be assessed: a. MPA area under curve (AUC). b. Clinical outcomes including rejection, graft function and proteinuria.
Interventions
Pantoprazole 40mg oral tablet once daily for 7 days. There will be a 1-week washout period between treatments.
Sponsors
Health Department of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
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.
Outcome results
None listed