Organ TransplantationPhase 4MOTOR-MPANCT00611494
Gastrointestinal Tolerability of MMF vs EC-MPS in Maintenance Transplant Patients Treated With Calcineurin Inhibitors
A Phase 4 study testing MMF and EC-MPS in people with Organ Transplantation, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of the study is to assess the gastrointestinal tolerability of EC-MPS compared to MMF in maintenance transplant patients on a calcineurin inhibitor regimen, who require MMF dose reductions of 25% or more due to GI complications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Organ Transplantation
- What is being tested?
- MMF and EC-MPS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- recipients of liver or kidney or heart or lung or kidney/pancreas transplants
- at least 1 month post solid organ transplant
- on an immunosuppressive regimen which includes MMF in combination with cyclosporine A or tacrolimus
- previous MMF dose reduction of minimum of 25% of total dose due to at least one gastrointestinal complication with MMF therapy
- age of 18-75 years
Who cannot join
- less than 1 month post transplant
- allergy (hypersensitivity) to MPA, MMF, EC-MPS or to any ingredients of Myfortic or CellCept
- unwillingness or inability to give written consent
- pregnant or nursing women, or women planning to become pregnant
- patients with GI symptoms due to reasons other than related to MMF therapy
- active Post Transplant Lymphoproliferative Disease (PTLD)
Show all 9Show fewer
- significant or uncontrolled concomitant infections or other serious medical problems
- active bacterial, viral or fungal infection
- inability to self-administer the Quality of Life questionnaires
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital - Multi Organ Transplant Program
Toronto, Ontario, M5G 2N2
Jill Sheedy, RN BScN, 416 340 4800 ext. 4540, jill.sheedy@uhn.on.ca
About this study
Official title: A Single Centre, Prospective, Open-Label, Parallel Group, Randomized Study to Compare the Gastrointestinal Tolerability of Mycophenolate Mofetil (MMF, CellCept) and Enteric-Coated Mycophenolate Sodium (EC-MPS, Myfortic) in Maintenance Transplant Patients Treated With Calcineurin Inhibitors
The purpose of the study is to assess the gastrointestinal tolerability of EC-MPS compared to MMF in maintenance transplant patients on a calcineurin inhibitor regimen, who require MMF dose reductions of 25% or more due to GI complications. The tested hypothesis is that the EC-MPS treatment is superior to the MMF therapy in terms of tolerability and that patients on the EC-MPS formulation will be able to tolerate higher doses compared to those on MMF.
Read the detailed description
The use of mycophenolate mofetil (MMF) in combination with a calcineurin inhibitor (CNI: tacrolimus or cyclosporine) has been shown to improve graft survival in renal, cardiac and liver transplantation patients. However, its use has been associated with significant side effects, including gastrointestinal complications, causing dose reductions, interruption or termination of the therapy. An alternate formulation: enteric coated mycophenolate sodium (EC-MPS) was designed to alleviate the severity of upper gastrointestinal side effects. Several trials detailed in the protocol suggest a benefit in GI related health following conversion from MMF to EC-MPS, however we believe that robust data are lacking.
- Conditions
- Organ Transplantation
- Being tested
- MMF, EC-MPS
- Keywords
- Drug tolerance, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMFDrug
Also called CellCept
Gradual optimization of drug dosage, as clinically tolerated.
EC-MPSDrug
Also called Myfortic
Conversion from MMF to EC-MPS. Gradual optimization of drug dosage, as clinically tolerated.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | MMF Receives: Drug: MMF |
| B | Active comparator | EC-MPS Receives: Drug: EC-MPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with at least 1 GI symptom that is continuing or starting after the 1-month dose stabilization period
Measured: 12 months
Secondary outcomes (4)
Analysis and comparison of various Gastrointestinal Symptom Rating and Quality of Life Questionnaire (the GSRS, GIQLI, PGWB,OTE for HRQoL) scores across and within the 2 cohorts.
Measured: At months 1, 3, 6, 12 post-study start
Incidence and severity of adverse events
Measured: months 3, 6, 12
Patient survival, graft survival and rejection episodes across the 2 cohorts
Measured: months 3, 6, 12
Dose reductions, interruptions, fractionations and patient withdrawals across the two cohorts due to adverse events
Measured: Months 6, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ TransplantationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- George Therapondos, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611494
- Sponsor's protocol ID
- 07-0398-A
- Acronym
- MOTOR-MPA
- Status last verified
- Feb 2009
- First submitted
- 29 Jan 2008
- Last updated
- 17 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Prospective, Open-Label, Parallel Group, Randomized Study to Compare the Gastrointestinal Tolerability of Mycophenolate Mofetil (MMF, CellCept) and Enteric-Coated Mycophenolate Sodium (EC-MPS, Myfortic) in Maintenance Transplant Patients Treated With Calcineurin Inhibitors
- ClinicalTrials.gov ID
- NCT00611494
- Acronym / sponsor ID
- MOTOR-MPA / 07-0398-A
- Conditions
- Organ Transplantation
- Keywords
- Drug tolerance, Quality of Life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 11 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the gastrointestinal tolerability of EC-MPS compared to MMF in maintenance transplant patients on a calcineurin inhibitor regimen, who require MMF dose reductions of 25% or more due to GI complications. The tested hypothesis is that the EC-MPS treatment is superior to the MMF therapy in terms of tolerability and that patients on the EC-MPS formulation will be able to tolerate higher doses compared to those on MMF.
Detailed description
The use of mycophenolate mofetil (MMF) in combination with a calcineurin inhibitor (CNI: tacrolimus or cyclosporine) has been shown to improve graft survival in renal, cardiac and liver transplantation patients. However, its use has been associated with significant side effects, including gastrointestinal complications, causing dose reductions, interruption or termination of the therapy. An alternate formulation: enteric coated mycophenolate sodium (EC-MPS) was designed to alleviate the severity of upper gastrointestinal side effects. Several trials detailed in the protocol suggest a benefit in GI related health following conversion from MMF to EC-MPS, however we believe that robust data are lacking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: MMFMMF |
| B | Active comparator | Drug: EC-MPSEC-MPS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- recipients of liver or kidney or heart or lung or kidney/pancreas transplants
- at least 1 month post solid organ transplant
- on an immunosuppressive regimen which includes MMF in combination with cyclosporine A or tacrolimus
- previous MMF dose reduction of minimum of 25% of total dose due to at least one gastrointestinal complication with MMF therapy
- age of 18-75 years
Key exclusion criteria (9 listed)
- less than 1 month post transplant
- allergy (hypersensitivity) to MPA, MMF, EC-MPS or to any ingredients of Myfortic or CellCept
- unwillingness or inability to give written consent
- pregnant or nursing women, or women planning to become pregnant
- patients with GI symptoms due to reasons other than related to MMF therapy
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 |
|---|---|---|
| MMFAlso: CellCeptGradual optimization of drug dosage, as clinically tolerated. | Drug | A |
| EC-MPSAlso: MyforticConversion from MMF to EC-MPS. Gradual optimization of drug dosage, as clinically tolerated. | Drug | B |
Primary outcome
The number of patients with at least 1 GI symptom that is continuing or starting after the 1-month dose stabilization period
Time frame: 12 months
4 secondary outcomes
Analysis and comparison of various Gastrointestinal Symptom Rating and Quality of Life Questionnaire (the GSRS, GIQLI, PGWB,OTE for HRQoL) scores across and within the 2 cohorts.
Time frame: At months 1, 3, 6, 12 post-study start
Incidence and severity of adverse events
Time frame: months 3, 6, 12
Patient survival, graft survival and rejection episodes across the 2 cohorts
Time frame: months 3, 6, 12
Dose reductions, interruptions, fractionations and patient withdrawals across the two cohorts due to adverse events
Time frame: Months 6, 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2009.
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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.
Toronto General Hospital - Multi Organ Transplant Program
Toronto, Canada
George Therapondos, MD principal investigator
University Health Network, Toronto
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 MMF and EC-MPS in people with Organ Transplantation, run by University Health Network, Toronto at 1 site in Canada.
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 9 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: status not confirmed, as of the sponsor's last update on 17 Feb 2009. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with at least 1 GI symptom that is continuing or starting after the 1-month dose stabilization period (time frame: 12 months). 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 17 Feb 2009.