Kidney TransplantationPhase 4NCT00149942
Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From Gastrointestinal (GI) Adverse Events While on Mycophenolate Mofetil Therapy (MMF) Therapy
A Phase 4 study testing Enteric-coated Mycophenolate sodium (EC-MPS) in people with Kidney Transplantation and Liver Transplantation, run by Novartis at 1 site in Switzerland.
Trial summary
This open, single arm, explorative study aims to investigate the evolution of gastrointestinal adverse events after switch from MMF to EC-MPS in organ transplanted patients suffering from gastrointestinal adverse events while on MMF therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation, Liver Transplantation
- What is being tested?
- Enteric-coated Mycophenolate sodium (EC-MPS)
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2004to Aug 2006
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Kidney or liver transplanted patients
- Currently under MMF therapy and currently suffering from upper or lower gastro-intestinal adverse events
Who cannot join
- Recent graft rejection before the study
- Other pre-existing conditions that may cause gastro-intestinal complaints
- Use of other drugs known to cause gastro-intestinal complaints
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-Coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From GI Adverse Events While on Mycophenolate Mofetil Therapy
This open, single arm, explorative study aims to investigate the evolution of gastrointestinal adverse events after switch from MMF to EC-MPS in organ transplanted patients suffering from gastrointestinal adverse events while on MMF therapy.
- Conditions
- Kidney Transplantation, Liver Transplantation
- Being tested
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Keywords
- Enteric coated mycophenolate sodium, transplantation, gastrointestinal adverse events, Kidney and liver transplantation patients experiencing GI AEs with current MMF treatment
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastro-intestinal adverse events before switch versus 3 months after switch
Secondary outcomes (5)
Time to the first biopsy-proven rejection after conversion.
Severity of biopsy-proven rejections after conversion.
Proportion of patients who had graft loss after conversion.
Frequency of adverse events
Frequency of infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149942
- Sponsor's protocol ID
- CERL080ABE01
- Status last verified
- Nov 2016
- First submitted
- 6 Sep 2005
- Last updated
- 18 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-Coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From GI Adverse Events While on Mycophenolate Mofetil Therapy
- ClinicalTrials.gov ID
- NCT00149942
- Acronym / sponsor ID
- CERL080ABE01
- Conditions
- Kidney Transplantation, Liver Transplantation
- Keywords
- Enteric coated mycophenolate sodium, transplantation, gastrointestinal adverse events, Kidney and liver transplantation patients experiencing GI AEs with current MMF treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 8 Sep 2005 (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 open, single arm, explorative study aims to investigate the evolution of gastrointestinal adverse events after switch from MMF to EC-MPS in organ transplanted patients suffering from gastrointestinal adverse events while on MMF therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Kidney or liver transplanted patients
- Currently under MMF therapy and currently suffering from upper or lower gastro-intestinal adverse events
Key exclusion criteria (4 listed)
- Recent graft rejection before the study
- Other pre-existing conditions that may cause gastro-intestinal complaints
- Use of other drugs known to cause gastro-intestinal complaints
- Other protocol-defined inclusion/exclusion criteria may apply
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 | – |
Primary outcome
Gastro-intestinal adverse events before switch versus 3 months after switch
5 secondary outcomes
Time to the first biopsy-proven rejection after conversion.
Severity of biopsy-proven rejections after conversion.
Proportion of patients who had graft loss after conversion.
Frequency of adverse events
Frequency of infections
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 18 Nov 2016.
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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) in people with Kidney Transplantation and Liver Transplantation, 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 2 inclusion and 4 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 18 Nov 2016. 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?
Gastro-intestinal adverse events before switch versus 3 months after switch. 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 18 Nov 2016.