Clinical trial NCT01801280: Influence of Pantoprazole on the Bioavailability of MMF and EC-MPS
Official title: Pharmacokinetic Cross-over Study to Evaluate the Influence of Pantoprazole on MPA Bioavailability Administered as Mycophenolate Mofetil and Enteric Coated Mycophenolate Sodium in Maintenance Renal Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Transplantation
Immunosuppression
Drug Interaction
Keywords: immunosuppressive medication
mycophenolic acid
interaction
proton pump inhibitor
pantoprazole
renal transplant patients
pharmacokinetics
pharmacodynamics
bioavailability
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2013-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Dose-normalized AUC of Mycophenolic Acid
timeFrame: Study duration for each patient: 2 months. After 10-14 days of drug intake blood samples for PK/PD analysis will be collected. On the next day new treatment starts. There are 4 study visits at the study center. Duration will be approximately 12hours
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Hospital Campus Mitte
Study officials:
affiliation: Charite University, Berlin, Germany
name: Klemens Budde, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: