Late Complication From Kidney TransplantNCT00715468
Prospective, 6 Month, Open Label, Conversion Study From Mycophenolate Mofetil (MMF) to PRMYFORTIC*
An observational study of Late Complication From Kidney Transplant, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
Treatment with MMF often results in adverse GI events, which can lead to dose reductions of MMF and decreased graft function. Enteric-coated mycophenolate sodium (MYFORTIC*) was developed as an alternative formulation of MPA to improve upper GI tract side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Late Complication From Kidney Transplant
- How many people
- 59 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2007to Apr 2014
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: renal transplant patients who have received a transplant at least 3 months and experiencing Gastrointestinal symptoms
Who may be able to join
- Received a kidney transplant at least six months
- stable graft function (no increased creatinine > 20% in the previous 4 weeks)
- Receiving immunosuppressive regimen with stable dose of MMF for at least 4 weeks
- Immunosuppressive regimen with a dose of MMF (dose≤ 2.0 g/day) at least 4 weeks OR C0 MMF < 1.4 µg/ml at visit 1 OR patients receiving MMF who have GI side effects
- Willing to provide written informed consent
- Women of childbearing age must have a negative pregnancy test and use a medically acceptable method of contraception throughout the treatment period;
- Over 18 years of age.
Who cannot join
- GI symptoms assumed or known not to be caused by MPA therapy;
- Acute rejection episode ≤ 4 weeks prior to study enrollment;
- Liver disease interfering with enterohepatic recirculation, such as active hepatitis B, active hepatitis C, autoimmune hepatitis and liver cirrhosis;
- Female patients who are pregnant, lactating or of child bearing potential and not practicing an approved method of birth control;
- Active bacterial, viral or fungal infection;
- Presence of psychiatric illness that in the view of the investigator would interfere with study requirements;
- Known sensitivity to the study drug;
- Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, 6 Month, Open Label, Conversion Study From MMF to MYFORTIC* Evaluating the Severity of GI Symptoms and MPA Metabolite as a Surrogate Marker of MYFORTIC
Treatment with MMF often results in adverse GI events, which can lead to dose reductions of MMF and decreased graft function. Enteric-coated mycophenolate sodium (MYFORTIC*) was developed as an alternative formulation of MPA to improve upper GI tract side effects. An improvement in the severity of GI side effects could result in an increased tolerance to MPA and an improvement in patient quality of life. This study will use the GSRS to evaluate improvement in gastrointestinal symptoms.
Read the detailed description
This study will evaluate the change in the total gastrointestinal symptom rating scale (GSRS) score at baseline versus month 1,at baseline versus month 3 and at baseline versus month 6 after conversion from MMF to PRMYFORTIC* .
- Conditions
- Late Complication From Kidney Transplant
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the change in the total gastrointestinal symptom rating scale(GSRS) score at baseline vs 1 month, va 3 month and vs 6 month
Measured: 1 month- 3 month-6 month
Secondary outcomes (3)
evaluate the change in the diarrhea GSRS subscale on a per patient basis
Measured: at month 6
incidence of adverse events and serious events at months 3 an d6 will be evaluated
Measured: month 3 and 6
Renal function and incidence of acute rejection
Measured: 1-3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startAug 2007
- Primary completionDec 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Complication From 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Suzon Collette, Maisonneuve-Rosemont Hospital
- Investigators
- Suzon Collette, Md, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715468
- Sponsor's protocol ID
- CERL080ACA07
- Status last verified
- Dec 2014
- First submitted
- 11 Jul 2008
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, 6 Month, Open Label, Conversion Study From MMF to MYFORTIC* Evaluating the Severity of GI Symptoms and MPA Metabolite as a Surrogate Marker of MYFORTIC
- ClinicalTrials.gov ID
- NCT00715468
- Acronym / sponsor ID
- CERL080ACA07
- Conditions
- Late Complication From Kidney Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Aug 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 15 Jul 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.
Treatment with MMF often results in adverse GI events, which can lead to dose reductions of MMF and decreased graft function. Enteric-coated mycophenolate sodium (MYFORTIC*) was developed as an alternative formulation of MPA to improve upper GI tract side effects. An improvement in the severity of GI side effects could result in an increased tolerance to MPA and an improvement in patient quality of life. This study will use the GSRS to evaluate improvement in gastrointestinal symptoms.
Detailed description
This study will evaluate the change in the total gastrointestinal symptom rating scale (GSRS) score at baseline versus month 1,at baseline versus month 3 and at baseline versus month 6 after conversion from MMF to PRMYFORTIC* .
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- renal transplant patients who have received a transplant at least 3 months and experiencing Gastrointestinal symptoms
Key inclusion criteria (7 listed)
- Received a kidney transplant at least six months
- stable graft function (no increased creatinine > 20% in the previous 4 weeks)
- Receiving immunosuppressive regimen with stable dose of MMF for at least 4 weeks
- Immunosuppressive regimen with a dose of MMF (dose≤ 2.0 g/day) at least 4 weeks OR C0 MMF < 1.4 µg/ml at visit 1 OR patients receiving MMF who have GI side effects
- Willing to provide written informed consent
Key exclusion criteria (8 listed)
- GI symptoms assumed or known not to be caused by MPA therapy;
- Acute rejection episode ≤ 4 weeks prior to study enrollment;
- Liver disease interfering with enterohepatic recirculation, such as active hepatitis B, active hepatitis C, autoimmune hepatitis and liver cirrhosis;
- Female patients who are pregnant, lactating or of child bearing potential and not practicing an approved method of birth control;
- Active bacterial, viral or fungal infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the change in the total gastrointestinal symptom rating scale(GSRS) score at baseline vs 1 month, va 3 month and vs 6 month
Time frame: 1 month- 3 month-6 month
3 secondary outcomes
evaluate the change in the diarrhea GSRS subscale on a per patient basis
Time frame: at month 6
incidence of adverse events and serious events at months 3 an d6 will be evaluated
Time frame: month 3 and 6
Renal function and incidence of acute rejection
Time frame: 1-3-6 months
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 12 Dec 2014.
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.
Suzon Collette, Md principal investigator
Maisonneuve-Rosemont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Late Complication From Kidney Transplant, run by Maisonneuve-Rosemont Hospital 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 7 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 12 Dec 2014. 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.
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?
Evaluate the change in the total gastrointestinal symptom rating scale(GSRS) score at baseline vs 1 month, va 3 month and vs 6 month (time frame: 1 month- 3 month-6 month). 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 12 Dec 2014.