Gastrointestinal SymptomsPhase 4NCT00574197
Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients
A Phase 4 study testing Mycophenolate Sodium in people with Gastrointestinal Symptoms and Heart Transplantation, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
Mycophenolate sodium (Myfortic®) is a newly developed enteric-coated tablet version of mycophenolate mofetil (Cellcept®) which is currently used as therapy for the prevention of transplant rejection. Myfortic® was developed to improve the gastrointestinal tolerability of Cellcept®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Symptoms, Heart Transplantation
- What is being tested?
- Mycophenolate Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Dec 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patients of either sex aged 18 and above who have undergone successful orthotopic heart transplant surgery.
- Patients who are currently taking Cellcept® and experiencing gastrointestinal side-effects from this standard therapy.
- Individuals on Cellcept® with total dosage of 2 mg a day or less would be eligible to participate.
- Patients who are able to give written informed consent.
Who cannot join
- Patients with an absolute neutrophil count <1500 cells/mm3, and/or leukocytopenia (<2500 cells/mm3), thrombocytopenia (<75,000 cells/mm3) and significant anemia (hemoglobin < 6g/dl) at the time of potential enrollment.
- Women of childbearing potential not using the contraception method(s), as well as women who are breastfeeding.
- Known sensitivity to the study drug or class of the study drug.
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
- Use of any other investigational agent in the last 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars- Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Assessment of Gastrointestinal Tolerability and Efficacy of Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients
Mycophenolate sodium (Myfortic®) is a newly developed enteric-coated tablet version of mycophenolate mofetil (Cellcept®) which is currently used as therapy for the prevention of transplant rejection. Myfortic® was developed to improve the gastrointestinal tolerability of Cellcept®. The new enteric-coated, Myfortic® is presently FDA approved for the prevention of acute kidney rejection only. There is no clinical data of its use in heart transplant patients.
Read the detailed description
This is an open-labeled, prospective, non-randomized pilot-phase study of the enteric-coated, Myfortic® versus the non enteric-coated, Cellcept® in patients who are within 5 years of having undergone heart transplant surgery who are currently taking Cellcept®. After the initial screening, 20 patients who fulfill the inclusion criteria and report symptoms of gastrointestinal side-effects while taking Cellcept will be switched to Myfortic. All 20 patients will be followed closely over a period of 6 months following enrollment. Concomitant immunosuppressive therapy will continue in all patients per standard treatment protocol.
- Conditions
- Gastrointestinal Symptoms, Heart Transplantation
- Being tested
- Mycophenolate Sodium
- Keywords
- Heart Transplant, gastrointestinal, Cellcept, Myfortic, GI, GI symptoms with Mycophenolate Mofetil post heart transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolate SodiumDrug
Also called Myfortic
1440mg/day (720mg by mouth, twice a day)
| Study group | Role | What they receive |
|---|---|---|
| Enteric-coated Mycophenolate Sodium (Myfortic) | Other | 1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months Receives: Drug: Mycophenolate Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI Tolerability as Measured by GSRS
Side-effects using the GSRS (Gastrointestinal Symptoms Rating Scale)
GSRS has 15 items, each rated on a 7-point scale from 1 (no discomfort) to 7 (very severe discomfort). GSRS total minimum value is 15; maximum value is 105. Higher scores represent greater discomfort.
Measured: Baseline and 6 months
Secondary outcomes (1)
Number of Biopsy Proven Acute Rejection, Graft Loss and Death Due to Rejection.
Number of biopsy proven acute rejection, graft loss, and death due to rejection.
Number of rejection episodes where rejection is defined as Grade 1B or higher on myocardial biopsy as measured by the 1990 Grading System of the International Society of Heart and Lung Transplantation for Acute Cellular Rejection. Grading system has:
- grade 0 (no acute rejection)
- grade 1A (Focal, mild acute rejection)
- grade 1B (Diffuse, mild acute rejection)
- grade 2 (Focal, moderate acute rejection)
- grade 3A (multifocal moderate rejection)
- grade 3B (Diffuse, borderline severe acute rejection)
- grade 4 (Severe acute rejection).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startJun 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastrointestinal SymptomsStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Lawrence Czer, Cedars-Sinai Medical Center
- Investigators
- Ernst Schwarz, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574197
- Sponsor's protocol ID
- 9810
- Status last verified
- Jul 2020
- First submitted
- 13 Dec 2007
- Last updated
- 30 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Gastrointestinal Tolerability and Efficacy of Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients
- ClinicalTrials.gov ID
- NCT00574197
- Acronym / sponsor ID
- 9810
- Conditions
- Gastrointestinal Symptoms, Heart Transplantation
- Keywords
- Heart Transplant, gastrointestinal, Cellcept, Myfortic, GI, GI symptoms with Mycophenolate Mofetil post heart transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Jun 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 Dec 2007 (estimated)
- Results
- Posted 8 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mycophenolate sodium (Myfortic®) is a newly developed enteric-coated tablet version of mycophenolate mofetil (Cellcept®) which is currently used as therapy for the prevention of transplant rejection. Myfortic® was developed to improve the gastrointestinal tolerability of Cellcept®. The new enteric-coated, Myfortic® is presently FDA approved for the prevention of acute kidney rejection only. There is no clinical data of its use in heart transplant patients.
Detailed description
This is an open-labeled, prospective, non-randomized pilot-phase study of the enteric-coated, Myfortic® versus the non enteric-coated, Cellcept® in patients who are within 5 years of having undergone heart transplant surgery who are currently taking Cellcept®. After the initial screening, 20 patients who fulfill the inclusion criteria and report symptoms of gastrointestinal side-effects while taking Cellcept will be switched to Myfortic. All 20 patients will be followed closely over a period of 6 months following enrollment. Concomitant immunosuppressive therapy will continue in all patients per standard treatment protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enteric-coated Mycophenolate Sodium (Myfortic) | Other | Drug: Mycophenolate Sodium1440mg/day (720mg by mouth, twice a day) of enteric-coated Mycophenolate Sodium (Myfortic) for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of either sex aged 18 and above who have undergone successful orthotopic heart transplant surgery.
- Patients who are currently taking Cellcept® and experiencing gastrointestinal side-effects from this standard therapy.
- Individuals on Cellcept® with total dosage of 2 mg a day or less would be eligible to participate.
- Patients who are able to give written informed consent.
Key exclusion criteria (5 listed)
- Patients with an absolute neutrophil count <1500 cells/mm3, and/or leukocytopenia (<2500 cells/mm3), thrombocytopenia (<75,000 cells/mm3) and significant anemia (hemoglobin < 6g/dl) at the time of potential enrollment.
- Women of childbearing potential not using the contraception method(s), as well as women who are breastfeeding.
- Known sensitivity to the study drug or class of the study drug.
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
- Use of any other investigational agent in the last 30 days.
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 |
|---|---|---|
| Mycophenolate SodiumAlso: Myfortic1440mg/day (720mg by mouth, twice a day) | Drug | Enteric-coated Mycophenolate Sodium (Myfortic) |
Primary outcome
GI Tolerability as Measured by GSRS
Time frame: Baseline and 6 months
Side-effects using the GSRS (Gastrointestinal Symptoms Rating Scale) GSRS has 15 items, each rated on a 7-point scale from 1 (no discomfort) to 7 (very severe discomfort). GSRS total minimum value is 15; maximum value is 105. Higher scores represent greater discomfort.
1 secondary outcome
Number of Biopsy Proven Acute Rejection, Graft Loss and Death Due to Rejection.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ernst Schwarz, MD principal investigator
Cedars-Sinai Medical Center
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 Mycophenolate Sodium in people with Gastrointestinal Symptoms and Heart Transplantation, run by Cedars-Sinai Medical Center 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 4 inclusion and 5 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 30 Jul 2020. 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.
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?
Yes. Results are posted in the registry (first posted 8 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
GI Tolerability as Measured by GSRS (time frame: Baseline and 6 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 30 Jul 2020.