The effect of proton pump inhibitor on mycophenolic acid absorption in kidney and liver transplant recipients
- Conditions
- Drug interactionRenal and Urogenital - Kidney disease
- Registration Number
- ACTRN12611000316909
- Lead Sponsor
- Health Department of Western Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 42
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose normalised area under the curve (AUC) for mycophenolic acid (MPA) and MPA-ether glucuronide (MPA-Ge) will be determined using validated assay[Days 7 and 21]
- Secondary Outcome Measures
Name Time Method Transplant graft outcomes (clinical assessments, blood and urine test)[Days 7 and 21];Plasma calcineurin-inhibitor levels (blood test)[Days 7 and 21];Plasma pantoprazole levels (blood test)[Days 7 and 21]