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

NCT01801280 | Completed Phase 4 Results

• 2 other identifiers: CERL 080A DE 20 T2010-021275-92
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Transplantation; Immunosuppression; Drug Interaction

Keywords

immunosuppressive medication; mycophenolic acid; interaction; proton pump inhibitor; pantoprazole; renal transplant patients; pharmacokinetics; pharmacodynamics; bioavailability

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Mycophenolate mofetil (C)

ACTIVE COMPARATOR

Mycophenolate mofetil (C) b.i.d. every 12 hours for 2 weeks.

Drug: Mycophenolate mofetil

Mycophenolate mofetil+Pantoprazole (C+P)

OTHER

Mycophenolate mofetil b.i.d and Pantoprazole o.m. for 2 weeks.

Drug: Pantoprazole; Drug: Mycophenolate mofetil

Mycophenolate sodium (M)

OTHER

Mycophenolate sodium (M) b.i.d. every 12 hours for 2 weeks.

Drug: Mycophenolate sodium

Mycophenolate sodium+Pantoprazole (M+P)

OTHER

Mycophenolate mofetil b.i.d and Pantoprazole 40mg o.m. for 2 weeks.

Drug: Mycophenolate sodium; Drug: Pantoprazole

Interventions

Mycophenolate sodium DRUG

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

Also known as: Myfortic®

Mycophenolate sodium (M); Mycophenolate sodium+Pantoprazole (M+P)

Pantoprazole DRUG

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

Also known as: Pantozol®

Mycophenolate mofetil+Pantoprazole (C+P); Mycophenolate sodium+Pantoprazole (M+P)

Mycophenolate mofetil DRUG

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

Also known as: Cellcept®

Mycophenolate mofetil (C); Mycophenolate mofetil+Pantoprazole (C+P)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients \>18 years old
• patients who are on stable immunosuppressive therapy for at least one month with ciclosporin, EC-MPS or MMF +/- corticosteroids
• 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%)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Klemens Budde: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Charité Hospital Campus Mitte

Berlin, 10117, Germany

Location

MeSH Terms

Interventions

Mycophenolic Acid; Pantoprazole

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Olesja Rissling
• Organization: Charité University Hospital - Department of Nephrology

olesja.rissling@charite.de

+49 30 450 514 153

Study Officials

• Klemens Budde, Prof Dr

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Dr Klemens Budde

Study Record Dates

• First Submitted: February 13, 2013
• First Posted: February 28, 2013
• Study Start: January 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2014
• Last Updated: February 21, 2019
• Results First Posted: September 9, 2016

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)