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

Immunosuppression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801280
• Other study ID #: CERL 080A DE 20 T
• Secondary ID: 2010-021275-92
• Status: Completed
• Phase: Phase 4
• Start date: January 2012
• Est. completion date: March 2014

Study information

• Verified date: February 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Drug Interaction
• Immunosuppression
• Transplantation

Intervention

Drug:
• Mycophenolate sodium
Daily dose: 720mg, 1080mg, 1440mg. Application alone or together with Pantozol®.
• Pantoprazole
Daily dose: 40mg. Application together with CellCept® or Myfortic® .
• Mycophenolate mofetil
Daily dose: 1000mg, 1500mg, 2000mg. Application alone or with Pantozol® .

Locations

Country	Name	City	State
Germany	Charité Hospital Campus Mitte	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Klemens Budde	Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-normalized AUC of Mycophenolic Acid	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