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Completed

NCT Number: NCT01801280

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

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

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Key information

Conditions

Transplantation Drug Interaction Immunosuppression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Charité Hospital Campus Mitte

Berlin, 10117, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mycophenolate sodium

Drug

Daily dose: 720mg, 1080mg, 1440mg. Application alone or together with Pantozol®.

Other names: Myfortic®

Pantoprazole

Drug

Daily dose: 40mg. Application together with CellCept® or Myfortic® .

Other names: Pantozol®

Mycophenolate mofetil

Drug

Daily dose: 1000mg, 1500mg, 2000mg. Application alone or with Pantozol® .

Other names: Cellcept®

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Klemens Budde

Other

Collaborators

  • Novartis Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Feb 28, 2013
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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