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Trial record 18 of 1177 for:    MYCOPHENOLIC ACID

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

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ClinicalTrials.gov Identifier: NCT01801280
Recruitment Status : Completed
First Posted : February 28, 2013
Results First Posted : September 9, 2016
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Klemens Budde, Charite University, Berlin, Germany

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

Condition or disease Intervention/treatment Phase
Transplantation Immunosuppression Drug Interaction Drug: Mycophenolate sodium Drug: Pantoprazole Drug: Mycophenolate mofetil Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2014


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 Name: Cellcept®

Mycophenolate mofetil+Pantoprazole (C+P)
Mycophenolate mofetil b.i.d and Pantoprazole o.m. for 2 weeks.
Drug: Pantoprazole
Daily dose: 40mg. Application together with CellCept® or Myfortic® .
Other Name: Pantozol®

Drug: Mycophenolate mofetil
Daily dose: 1000mg, 1500mg, 2000mg. Application alone or with Pantozol® .
Other Name: Cellcept®

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 Name: Myfortic®

Mycophenolate sodium+Pantoprazole (M+P)
Mycophenolate mofetil b.i.d and Pantoprazole 40mg o.m. for 2 weeks.
Drug: Mycophenolate sodium
Daily dose: 720mg, 1080mg, 1440mg. Application alone or together with Pantozol®.
Other Name: Myfortic®

Drug: Pantoprazole
Daily dose: 40mg. Application together with CellCept® or Myfortic® .
Other Name: Pantozol®




Primary Outcome Measures :
  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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801280


Locations
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Germany
Charité Hospital Campus Mitte
Berlin, Germany, 10117
Sponsors and Collaborators
Klemens Budde
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Klemens Budde, Prof Dr Charite University, Berlin, Germany

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Responsible Party: Klemens Budde, Professor Dr Klemens Budde, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01801280     History of Changes
Other Study ID Numbers: CERL 080A DE 20 T
2010-021275-92 ( EudraCT Number )
First Posted: February 28, 2013    Key Record Dates
Results First Posted: September 9, 2016
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Klemens Budde, Charite University, Berlin, Germany:
immunosuppressive medication
mycophenolic acid
interaction
proton pump inhibitor
pantoprazole
renal transplant patients
pharmacokinetics
pharmacodynamics
bioavailability
Additional relevant MeSH terms:
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Mycophenolic Acid
Pantoprazole
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors