TransplantationPhase 4NCT01801280
Influence of Pantoprazole on the Bioavailability of MMF and EC-MPS
A Phase 4 study testing Mycophenolate sodium, Pantoprazole and Mycophenolate mofetil in people with Transplantation and Immunosuppression, run by Klemens Budde at 1 site in Germany.
Trial summary
The objective of this pharmacokinetic study is to examine a possible drug-drug interaction of Pantoprazole on the bioavailability mycophenolic acid. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplantation, Immunosuppression, Drug Interaction
- What is being tested?
- Mycophenolate sodium, Pantoprazole and Mycophenolate mofetil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Mar 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%)
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
The objective of this pharmacokinetic study is to examine a possible drug-drug interaction of Pantoprazole on the bioavailability mycophenolic acid.
Read the 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).
- Conditions
- Transplantation, Immunosuppression, Drug Interaction
- Being tested
- Mycophenolate sodium, Pantoprazole, Mycophenolate mofetil
- Keywords
- immunosuppressive medication, mycophenolic acid, interaction, proton pump inhibitor, pantoprazole, renal transplant patients, pharmacokinetics, pharmacodynamics, bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolate sodiumDrug
Also called Myfortic®
Daily dose: 720mg, 1080mg, 1440mg. Application alone or together with Pantozol®.
PantoprazoleDrug
Also called Pantozol®
Daily dose: 40mg. Application together with CellCept® or Myfortic® .
Also called Cellcept®
Daily dose: 1000mg, 1500mg, 2000mg. Application alone or with Pantozol® .
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolate mofetil (C) | Active comparator | Mycophenolate mofetil (C) b.i.d. every 12 hours for 2 weeks. Receives: Drug: Mycophenolate mofetil |
| Mycophenolate mofetil+Pantoprazole (C+P) | Other | Mycophenolate mofetil b.i.d and Pantoprazole o.m. for 2 weeks. Receives: Drug: Pantoprazole; Drug: Mycophenolate mofetil |
| Mycophenolate sodium (M) | Other | Mycophenolate sodium (M) b.i.d. every 12 hours for 2 weeks. Receives: Drug: Mycophenolate sodium |
| Mycophenolate sodium+Pantoprazole (M+P) | Other | Mycophenolate mofetil b.i.d and Pantoprazole 40mg o.m. for 2 weeks. Receives: Drug: Mycophenolate sodium; Drug: Pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startJan 2012
- Primary completionMar 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klemens Budde
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor-investigator, Klemens Budde, Charite University, Berlin, Germany
- Investigators
- Klemens Budde, Prof Dr, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801280
- Sponsor's protocol ID
- CERL 080A DE 20 T
- Other IDs
- 2010-021275-92
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2013
- Last updated
- 21 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01801280
- Acronym / sponsor ID
- CERL 080A DE 20 T
- Conditions
- Transplantation, Immunosuppression, Drug Interaction
- Keywords
- immunosuppressive medication, mycophenolic acid, interaction, proton pump inhibitor, pantoprazole, renal transplant patients, pharmacokinetics, pharmacodynamics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Klemens BuddeUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Feb 2013 (estimated)
- Results
- Posted 9 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this pharmacokinetic study is to examine a possible drug-drug interaction of Pantoprazole on the bioavailability mycophenolic acid.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mycophenolate mofetil (C) | Active comparator | Drug: Mycophenolate mofetilMycophenolate mofetil (C) b.i.d. every 12 hours for 2 weeks. |
| Mycophenolate mofetil+Pantoprazole (C+P) | Other | Drug: Pantoprazole, Drug: Mycophenolate mofetilMycophenolate mofetil b.i.d and Pantoprazole o.m. for 2 weeks. |
| Mycophenolate sodium (M) | Other | Drug: Mycophenolate sodiumMycophenolate sodium (M) b.i.d. every 12 hours for 2 weeks. |
| Mycophenolate sodium+Pantoprazole (M+P) | Other | Drug: Mycophenolate sodium, Drug: PantoprazoleMycophenolate mofetil b.i.d and Pantoprazole 40mg o.m. for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mycophenolate sodiumAlso: Myfortic®Daily dose: 720mg, 1080mg, 1440mg. Application alone or together with Pantozol®. | Drug | Mycophenolate sodium (M), Mycophenolate sodium+Pantoprazole (M+P) |
| PantoprazoleAlso: Pantozol®Daily dose: 40mg. Application together with CellCept® or Myfortic® . | Drug | Mycophenolate mofetil+Pantoprazole (C+P), Mycophenolate sodium+Pantoprazole (M+P) |
| Mycophenolate mofetilAlso: Cellcept®Daily dose: 1000mg, 1500mg, 2000mg. Application alone or with Pantozol® . | Drug | Mycophenolate mofetil (C), Mycophenolate mofetil+Pantoprazole (C+P) |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klemens Budde, Prof Dr principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mycophenolate sodium, Pantoprazole and Mycophenolate mofetil in people with Transplantation and Immunosuppression, run by Klemens Budde at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.