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

February 4, 2019 updated by: Klemens Budde

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité Hospital Campus Mitte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mycophenolate mofetil (C)
Mycophenolate mofetil (C) b.i.d. every 12 hours for 2 weeks.
Drug: Mycophenolate mofetil
Daily dose: 1000mg, 1500mg, 2000mg. Application alone or with Pantozol® .
Other Names:
  • Cellcept®
Other: Mycophenolate mofetil+Pantoprazole (C+P)
Mycophenolate mofetil b.i.d and Pantoprazole o.m. for 2 weeks.
Drug: Mycophenolate mofetil
Daily dose: 1000mg, 1500mg, 2000mg. Application alone or with Pantozol® .
Other Names:
  • Cellcept®
Drug: Pantoprazole
Daily dose: 40mg. Application together with CellCept® or Myfortic® .
Other Names:
  • Pantozol®
Other: Mycophenolate sodium (M)
Mycophenolate sodium (M) b.i.d. every 12 hours for 2 weeks.
Drug: Mycophenolate sodium
Daily dose: 720mg, 1080mg, 1440mg. Application alone or together with Pantozol®.
Other Names:
  • Myfortic®
Other: Mycophenolate sodium+Pantoprazole (M+P)
Mycophenolate mofetil b.i.d and Pantoprazole 40mg o.m. for 2 weeks.
Drug: Pantoprazole
Daily dose: 40mg. Application together with CellCept® or Myfortic® .
Other Names:
  • Pantozol®
Drug: Mycophenolate sodium
Daily dose: 720mg, 1080mg, 1440mg. Application alone or together with Pantozol®.
Other Names:
  • Myfortic®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-normalized AUC of Mycophenolic Acid
Time Frame: 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

Bioavailability (12h AUC) of mycophenolic acid in renal transplant patients after administration of MMF+/-PAN and EC-MPS+/-PAN

For evaluation of pharmacokinetic and pharmacodynamic parameters blood will be collected before, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h after drug intake.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klemens Budde

Collaborators

Novartis Pharmaceuticals

Investigators

  • Principal Investigator: Klemens Budde, Prof Dr, Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

February 13, 2013

First Submitted That Met QC Criteria

February 26, 2013

First Posted (Estimate)

February 28, 2013

Study Record Updates

Last Update Posted (Actual)

February 21, 2019

Last Update Submitted That Met QC Criteria

February 4, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CERL 080A DE 20 T
  • 2010-021275-92 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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