Influence of Pantoprazole on the Bioavailability of MMF and EC-MPS

Klemens Budde

Status and phase: Completed; Phase 4

Conditions: Drug Interaction; Immunosuppression; Transplantation

Treatments: Drug: Mycophenolate sodium; Drug: Mycophenolate mofetil; Drug: Pantoprazole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01801280

CERL 080A DE 20 T

2010-021275-92 (EudraCT Number)

Details and patient eligibility

About

The objective of this pharmacokinetic study is to examine a possible drug-drug interaction of Pantoprazole on the bioavailability mycophenolic acid.

Full description

It is a randomized open-label 4-sequence 4-period pharmacokinetic cross-over study. The objective of the pharmacokinetic study is to examine a drug-drug interaction of pantoprazole on the bioavailability mycophenolic acid administered as either mycophenolate mofetil (Cellcept(R) or mycophenolate Sodium; EC-MPS (Myfortic (R) in stable renal allograft recipients under maintenance immunosuppressive therapy (cyclosporine +/- low dose glucocorticoids).

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients >18 years old
• patients who are on stable immunosuppressive therapy for at least one month with ciclosporin, EC-MPS or MMF +/- corticosteroids
• renal transplantation, at least 6 months prior study inclusion
• suitable and willing to switch treatment according to the study plan
• women of childbearing potential must have a negative serum pregnancy test before study start and effective contraception must be used (method with PEARL index <1%)

Exclusion criteria

• patients with renal function <30ml/min (estimated by Cockcroft Gault formula)
• patients who are not on stable treatment with enzyme inductors or enzyme inhibitors for <1 month before study entry
• patients who take medication which is known for interfering with MPA absorption for <1 month before study entry
• known anamnestic hypersensitivity to one of the investigational products or drugs with similar chemical structure and to other components of the investigational products, respectively
• patients on treatment with clopidogrel
• acute rejection < 1 month before study inclusion
• patients who are HIV positive, hepatitis C virus (HCV) positive, HBsAg positive
• patients with gastrointestinal disorders which could affect resorption
• pregnancy and/or lactation
• drug or alcohol abuse in patient's history
• patients with history of psychological illness or condition, which might interfere with the ability to understand the requirements, consequences, possible outcome of the study and patients who are not willing to give valid informed consent
• patients with insufficient co-operation with the clinical investigator (e.g. suspicion of non-compliance)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Mycophenolate mofetil (C)

Active Comparator group

Description:

Mycophenolate mofetil (C) b.i.d. every 12 hours for 2 weeks.

Treatment:

Drug: Mycophenolate mofetil

Mycophenolate mofetil+Pantoprazole (C+P)

Other group

Description:

Mycophenolate mofetil b.i.d and Pantoprazole o.m. for 2 weeks.

Treatment:

Drug: Pantoprazole

Drug: Mycophenolate mofetil

Mycophenolate sodium (M)

Other group

Description:

Mycophenolate sodium (M) b.i.d. every 12 hours for 2 weeks.

Treatment:

Drug: Mycophenolate sodium

Mycophenolate sodium+Pantoprazole (M+P)

Other group

Description:

Mycophenolate mofetil b.i.d and Pantoprazole 40mg o.m. for 2 weeks.

Treatment:

Drug: Pantoprazole

Drug: Mycophenolate sodium