Maintenance Kidney TransplantPhase 4NCT00400647
Gastrointestinal and Health-related Quality of Life in Kidney Transplant Patients Treated With Mycophenolate Mofetil
A Phase 4 study testing Enteric-coated Mycophenolate sodium (EC-MPS) and Mycophenolate mofetil in people with Maintenance Kidney Transplant, run by Novartis at 1 site in Switzerland.
Trial summary
This study will assess the quality of life in renal transplant recipients who require a reduced dose of mycophenolate mofetil (MMF) because of gastrointestinal (GI) side effects and will also access the relationship between mycophenolic acid (MPA) dose in those patients receiving enteric-coated mycophenolate sodium… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Maintenance Kidney Transplant
- What is being tested?
- Enteric-coated Mycophenolate sodium (EC-MPS) and Mycophenolate mofetil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2006to Sep 2008
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are recipients of a renal transplant.
- Patients treated with an immunosuppressive regiment including MMF before recruitment.
- Patients suffering from GI side effects related to MMF standard doses or patients treated with a reduced MMF dose to control the aforementioned GI side effects.
- Patients 18 years or older.
- Patients who have given written informed consent to participate in the study
- Patients complying with all study requirements including completing questionnaires and attending to the three study visits.
Who cannot join
- Patients with GI symptoms assumed or known not to be caused by MPA therapy (eg. oral bisphosphonate induced, infectious diarrhea)
- Acute rejection less than 1 week before recruitment.
- Females of childbearing potential who are pregnant, planning to get pregnant and/or breast feeding or not willing to practice an approved method of birth control.
- Presence of psychiatric disorder, such as schizophrenia or major depression, in the investigator's opinion, could interfere with study requirements.
- Patients undergoing surgery due to acute illness or hospitalized.
- Existence of any medical condition which, in the investigator's opinion based on anamnesis or medical records, could affect study completion, including but not limiting visual problems or cognitive deterioration.
- Patients currently treated or who have been treated with any other study drug or treatment within 30 days prior to baseline visit.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 12-week Multicenter, Randomized, Open Study to Evaluate the Effects of Enteric-coated Mycophenolate Sodium (EC-MPS) in Terms of Quality of Life in Patients With Gastrointestinal (GI) Symptoms Treated With MMF (Mycophenolate Mofetil) After Kidney Transplant.
This study will assess the quality of life in renal transplant recipients who require a reduced dose of mycophenolate mofetil (MMF) because of gastrointestinal (GI) side effects and will also access the relationship between mycophenolic acid (MPA) dose in those patients receiving enteric-coated mycophenolate sodium formulation(EC-MPS).
Patients will be evaluated at baseline, 2 weeks after study medicine conversion and then again at 12 weeks post-conversion.
- Conditions
- Maintenance Kidney Transplant
- Being tested
- Enteric-coated Mycophenolate sodium (EC-MPS), Mycophenolate mofetil
- Keywords
- kidney transplant, enteric-coated mycophenolate sodium, quality of life, gastrointestinal symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteric-coated Mycophenolate sodium (EC-MPS)Drug
| Study group | Role | What they receive |
|---|---|---|
| EC MPS | Experimental | Up to 1440mg taken in two doses Receives: Drug: Enteric-coated Mycophenolate sodium (EC-MPS) |
| Mycophenolate mofetil | Active comparator | 250 mg or 500 mg in two equal doses Receives: Drug: Mycophenolate mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of the use of EC-MPS on the quality of life of patients requiring MMF dose reduction due to gastrointestinal symptoms
Measured: 12 weeks
Secondary outcomes (2)
To determine whether EC-MPS enables the administration of higher doses with good tolerability, compared with standard MMF treatment, in patients with shown susceptibility to undesirable GI effects
Measured: 12 weeks
To measure health-related quality of life (HRQOL) through the GI quality of life index (GIQLI) and the psychological general well-being index (PGWB)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startJul 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maintenance Kidney TransplantStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400647
- Sponsor's protocol ID
- CERL080AES06
- Status last verified
- Feb 2017
- First submitted
- 16 Nov 2006
- Last updated
- 7 Feb 2017
- Results posted
- No
Publications
Ortega F, Sanchez-Fructuoso A, Cruzado JM, Gomez-Alamillo JC, Alarcon A, Pallardo L, Morales JM, Oliver J, Guinea G; MYVIDA Study Group. Gastrointestinal quality of life improvement of renal transplant recipients converted from mycophenolate mofetil to enteric-coated mycophenolate sodium drugs or agents: mycophenolate mofetil and enteric-coated mycophenolate sodium. Transplantation. 2011 Aug 27;92(4):426-32. doi: 10.1097/TP.0b013e31822527ca.
PubMed 21760569
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Multicenter, Randomized, Open Study to Evaluate the Effects of Enteric-coated Mycophenolate Sodium (EC-MPS) in Terms of Quality of Life in Patients With Gastrointestinal (GI) Symptoms Treated With MMF (Mycophenolate Mofetil) After Kidney Transplant.
- ClinicalTrials.gov ID
- NCT00400647
- Acronym / sponsor ID
- CERL080AES06
- Conditions
- Maintenance Kidney Transplant
- Keywords
- kidney transplant, enteric-coated mycophenolate sodium, quality of life, gastrointestinal symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 17 Nov 2006 (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.
This study will assess the quality of life in renal transplant recipients who require a reduced dose of mycophenolate mofetil (MMF) because of gastrointestinal (GI) side effects and will also access the relationship between mycophenolic acid (MPA) dose in those patients receiving enteric-coated mycophenolate sodium formulation(EC-MPS).
Patients will be evaluated at baseline, 2 weeks after study medicine conversion and then again at 12 weeks post-conversion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EC MPS | Experimental | Drug: Enteric-coated Mycophenolate sodium (EC-MPS)Up to 1440mg taken in two doses |
| Mycophenolate mofetil | Active comparator | Drug: Mycophenolate mofetil250 mg or 500 mg in two equal doses |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who are recipients of a renal transplant.
- Patients treated with an immunosuppressive regiment including MMF before recruitment.
- Patients suffering from GI side effects related to MMF standard doses or patients treated with a reduced MMF dose to control the aforementioned GI side effects.
- Patients 18 years or older.
- Patients who have given written informed consent to participate in the study
Key exclusion criteria (8 listed)
- Patients with GI symptoms assumed or known not to be caused by MPA therapy (eg. oral bisphosphonate induced, infectious diarrhea)
- Acute rejection less than 1 week before recruitment.
- Females of childbearing potential who are pregnant, planning to get pregnant and/or breast feeding or not willing to practice an approved method of birth control.
- Presence of psychiatric disorder, such as schizophrenia or major depression, in the investigator's opinion, could interfere with study requirements.
- Patients undergoing surgery due to acute illness or hospitalized.
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 |
|---|---|---|
| Enteric-coated Mycophenolate sodium (EC-MPS) | Drug | EC MPS |
| Mycophenolate mofetil | Drug | Mycophenolate mofetil |
Primary outcome
To determine the effect of the use of EC-MPS on the quality of life of patients requiring MMF dose reduction due to gastrointestinal symptoms
Time frame: 12 weeks
2 secondary outcomes
To determine whether EC-MPS enables the administration of higher doses with good tolerability, compared with standard MMF treatment, in patients with shown susceptibility to undesirable GI effects
Time frame: 12 weeks
To measure health-related quality of life (HRQOL) through the GI quality of life index (GIQLI) and the psychological general well-being index (PGWB)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Results publication: PubMed 21760569Ortega F, Sanchez-Fructuoso A, Cruzado JM, Gomez-Alamillo JC, Alarcon A, Pallardo L, Morales JM, Oliver J, Guinea G; MYVIDA Study Group. Gastrointestinal quality of life improvement of renal transplant recipients converted from mycophenolate mofetil to enteric-coated mycophenolate sodium drugs or agents: mycophenolate mofetil and enteric-coated mycophenolate sodium. Transplantation. 2011 Aug 27;92(4):426-32. doi: 10.1097/TP.0b013e31822527ca.
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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.
Novartis study director
Novartis
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 Enteric-coated Mycophenolate sodium (EC-MPS) and Mycophenolate mofetil in people with Maintenance Kidney Transplant, run by Novartis at 1 site in Switzerland.
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 6 inclusion and 8 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 7 Feb 2017. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the effect of the use of EC-MPS on the quality of life of patients requiring MMF dose reduction due to gastrointestinal symptoms (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00400647, which also lists 1 linked publication.
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 7 Feb 2017.