Lung TransplantationNCT01044667
A Gastrointestinal Quality of Life Study in Lung Transplant Recipients Converted From Mycophenolate Mofetil to Myfortic
A study testing GI and Quality of Life Assessment in people with Lung Transplantation, run by Vanderbilt University at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate gastrointestinal (GI) symptoms and health related quality of life in lung transplant recipients converted from Mycophenolate Mofetil (MMF) to Myfortic as part of standard immunosuppressive therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- GI and Quality of Life Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2012
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability and willingness to provide written informed consent and adhere to study regimen
- Recipients who are 18-70 years of age
- Patients who have undergone either single or double lung transplant are discharged on the standard MMF (no generic MMF will be used) therapy and complain of GI symptoms, thought to be related to their immunosuppressive regimen
Who cannot join
- Patients who have GI complaints thought to be due to factors other than immunosuppressive regimen
- Patients receiving steroid treatment for acute rejection
- Women of childbearing potential who do not agree to use at least two acceptable forms of contraception prior to starting study drug, while taking study drug, and for 6 weeks after stopping study drug
- Women who have a positive serum or urine pregnancy test at visit 1 and/or continuing through the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-4753
About this study
Official title: Reduced Gastrointestinal Complaints and Improved Quality of Life in Lung Transplant Recipients Converted From Mycophenolate Mofetil (MMF) to Myfortic (Enteric-coated Mycophenolate Sodium, Ec-mps)
The primary objective of this study is to evaluate gastrointestinal (GI) symptoms and health related quality of life in lung transplant recipients converted from Mycophenolate Mofetil (MMF) to Myfortic as part of standard immunosuppressive therapy.
Read the detailed description
Subjects administered MMF as part of their immunosuppression regimen after lung transplantation have a high incidence of GI symptoms related to the known side-effects of this drug. Previous studies have shown that GI symptoms are an important predictor of health related quality of life in other solid organ transplants (1). GI complications are common after lung transplant (2). We hypothesize that lung transplant patients converted from MMF to Myfortic will have significant reduction in severity of GI complaints. We also hypothesize that improvement in the severity of GI complaints will lead to an improved quality of life in these subjects. The study also includes data to evaluate the effect of GI complaints on health related quality of life.
Patients will complete questionnaires at each visit. Calls from the patients to the lung transplant center with GI complaints will be queried and documented on the case report form by the research nurse at each study visit. Similarly, hospital admissions for GI related complaints in the cohort will be documented. Symptom severity and health related quality of life will be assessed through the following questionnaires that have previously been validated in populations other than lung transplant (1). These questionnaires are selected specifically to capture the impact of GI complaints as related to the health related quality of life. The questionnaires that will be completed by the patient:
i.Gastrointestinal Quality of Life Index (GIQLI)
- The GIQLI is a 36-item questionnaire that assess the impact of GI distress on daily life ii.SF-36 Health Survey • "The SF-36 Health Survey is a questionnaire that capture practical, reliable, and valid information about functional health and well-being from the patients' point of view" (4) iii.EQ-5D Health Questionnaire
- "The EQ-5D is a standardized instrument for use as a measure of health outcome. The EQ-5D provides a simple descriptive profile and a single value for health status" (5)
Patients will complete the three questionnaires at 4 outpatient visits occurring:
- when the patient comes in to an outpatient clinic visit after initial hospital discharge after lung transplantation with complaints of GI distress (Day 1-Convert to Myfortic);
- 60 Days;
- 90 days;
- 180 days
- Conditions
- Lung Transplantation
- Being tested
- GI and Quality of Life Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI and Quality of Life AssessmentBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Patients taking Myfortic | Other | Lung transplant patients converted from MMF to Myfortic as part of standard of care treatment will have GI and Quality of Life assessments done at the time of conversion to Myfortic and at 60 days, 90 days and 180 days. Receives: Behavioral: GI and Quality of Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gastrointestinal Quality of Life Index (GIQLI), Baseline to 60 days:
Change in GIQLI after conversion from MMF to Myfortic
Measured: Change from Baseline to 60 days
Change in SF-36 Health Survey, Baseline to 60 days
Change in SF-36 Health Survey after conversion from MMF to Myfortic
Measured: Change from Baseline to 60 days
Change in EQ-5D Health Questionnaire, Baseline to 90 days
Change in EQ-5D Health Questionnaire after conversion from MMF to Myfortic
Measured: Change from Baseline to 60 days
Secondary outcomes (3)
Gastrointestinal Quality of Life Index (GIQLI)
Change in GIQLI after conversion from MMF to Myfortic
Measured: Day 90 and Day 180
SF-36 Health Survey
Change in SF-36 Health Survey after conversion from MMF to Myfortic
Measured: Day 90 and Day 180
EQ-5D Health Questionnaire
Change in EQ-5D Health Questionnaire after conversion from MMF to Myfortic
Measured: Day 90 and Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2012
- Study completionDec 2012
Why it stopped: poor enrollment and lack of study staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Eric Lambright, MD, Principal investigator, Vanderbilt University Medcial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044667
- Sponsor's protocol ID
- Myfortic 091423
- Status last verified
- Feb 2018
- First submitted
- 6 Jan 2010
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Gastrointestinal Complaints and Improved Quality of Life in Lung Transplant Recipients Converted From Mycophenolate Mofetil (MMF) to Myfortic (Enteric-coated Mycophenolate Sodium, Ec-mps)
- ClinicalTrials.gov ID
- NCT01044667
- Acronym / sponsor ID
- Myfortic 091423
- Conditions
- Lung Transplantation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor enrollment and lack of study staff
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Jan 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Jan 2010 (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 primary objective of this study is to evaluate gastrointestinal (GI) symptoms and health related quality of life in lung transplant recipients converted from Mycophenolate Mofetil (MMF) to Myfortic as part of standard immunosuppressive therapy.
Detailed description
Subjects administered MMF as part of their immunosuppression regimen after lung transplantation have a high incidence of GI symptoms related to the known side-effects of this drug. Previous studies have shown that GI symptoms are an important predictor of health related quality of life in other solid organ transplants (1). GI complications are common after lung transplant (2). We hypothesize that lung transplant patients converted from MMF to Myfortic will have significant reduction in severity of GI complaints. We also hypothesize that improvement in the severity of GI complaints will lead to an improved quality of life in these subjects. The study also includes data to evaluate the effect of GI complaints on health related quality of life.
Patients will complete questionnaires at each visit. Calls from the patients to the lung transplant center with GI complaints will be queried and documented on the case report form by the research nurse at each study visit. Similarly, hospital admissions for GI related complaints in the cohort will be documented. Symptom severity and health related quality of life will be assessed through the following questionnaires that have previously been validated in populations other than lung transplant (1). These questionnaires are selected specifically to capture the impact of GI complaints as related to the health related quality of life. The questionnaires that will be completed by the patient:
i.Gastrointestinal Quality of Life Index (GIQLI)
- The GIQLI is a 36-item questionnaire that assess the impact of GI distress on daily life ii.SF-36 Health Survey • "The SF-36 Health Survey is a questionnaire that capture practical, reliable, and valid information about functional health and well-being from the patients' point of view" (4) iii.EQ-5D Health Questionnaire
- "The EQ-5D is a standardized instrument for use as a measure of health outcome. The EQ-5D provides a simple descriptive profile and a single value for health status" (5)
Patients will complete the three questionnaires at 4 outpatient visits occurring:
- when the patient comes in to an outpatient clinic visit after initial hospital discharge after lung transplantation with complaints of GI distress (Day 1-Convert to Myfortic);
- 60 Days;
- 90 days;
- 180 days
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients taking Myfortic | Other | Behavioral: GI and Quality of Life AssessmentLung transplant patients converted from MMF to Myfortic as part of standard of care treatment will have GI and Quality of Life assessments done at the time of conversion to Myfortic and at 60 days, 90 days and 180 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability and willingness to provide written informed consent and adhere to study regimen
- Recipients who are 18-70 years of age
- Patients who have undergone either single or double lung transplant are discharged on the standard MMF (no generic MMF will be used) therapy and complain of GI symptoms, thought to be related to their immunosuppressive regimen
Key exclusion criteria (4 listed)
- Patients who have GI complaints thought to be due to factors other than immunosuppressive regimen
- Patients receiving steroid treatment for acute rejection
- Women of childbearing potential who do not agree to use at least two acceptable forms of contraception prior to starting study drug, while taking study drug, and for 6 weeks after stopping study drug
- Women who have a positive serum or urine pregnancy test at visit 1 and/or continuing through the study
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 |
|---|---|---|
| GI and Quality of Life Assessment | Behavioural | Patients taking Myfortic |
Primary outcome
Change in Gastrointestinal Quality of Life Index (GIQLI), Baseline to 60 days:
Time frame: Change from Baseline to 60 days
Change in GIQLI after conversion from MMF to Myfortic
Change in SF-36 Health Survey, Baseline to 60 days
Time frame: Change from Baseline to 60 days
Change in SF-36 Health Survey after conversion from MMF to Myfortic
Change in EQ-5D Health Questionnaire, Baseline to 90 days
Time frame: Change from Baseline to 60 days
Change in EQ-5D Health Questionnaire after conversion from MMF to Myfortic
3 secondary outcomes
Gastrointestinal Quality of Life Index (GIQLI)
Time frame: Day 90 and Day 180
SF-36 Health Survey
Time frame: Day 90 and Day 180
EQ-5D Health Questionnaire
Time frame: Day 90 and Day 180
Results and safety
The study was stopped early (reason given: poor enrollment and lack of study staff). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
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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.
Eric Lambright, MD principal investigator
Vanderbilt University Medcial Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GI and Quality of Life Assessment in people with Lung Transplantation, run by Vanderbilt University at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 20 Feb 2018. 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 United States. 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 was stopped early (reason given: poor enrollment and lack of study staff). Results are not available in the source record.
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?
Change in Gastrointestinal Quality of Life Index (GIQLI), Baseline to 60 days: (time frame: Change from Baseline to 60 days). The study lists 3 primary outcomes in all. 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 20 Feb 2018.