The purpose of this study is to learn more about symptoms and gastrointestinal lesions
associated with taking myfortic® by switching patients to a delayed release formulation that
is developed to alleviate GI symptoms. A comparison of the frequency and severity of GI
symptoms observed in patients treated with MMF (cellcept®) after conversion to myfortic®
will be measured by using a self-assessed questionnaire called Gastrointestinal Symptom
Rating Scale (GSRS). To prove the incidence and improvement of GI lesions in patients
treated with MMF (cellcept®) after conversion to myfortic® will be measured by using Small
Bowel Capsule Endoscopy (SBCE).
Myfortic® recently introduced to the market has shown to be similar to MMF in how
effectively it works and how well it is tolerated. Both drugs have the same active
ingredient, but they are different in the way that they deliver them to the body. Myfortic®
is an advanced, enteric coated formulation of mycophenolate sodium (EC-MPS) that delays the
release of the active ingredient, MPA. MPA has more potent effects on the lymphocytes than
other cells. This makes for improved GI tolerability of the MPA therapy.
- Male or female patients between 18 and 75 years of age.
- Recipients of first or second cadaveric, living unrelated or living related kidney
- Recipients who are at least 4 weeks post renal transplantation with stable renal
- Patients who have used MMF at least 10 days and are currently receiving MMF. (up to
3g/day dosage allowed)
- Patients with at least one moderate or severe upper or lower GI complaints.
- Patients' immunosuppressive regimen other than steroids as well as medication for
treatment of GI symptoms must be unchanged for at least 1 week prior to study start.
- Females of childbearing potential must have a negative pregnancy test prior to the
inclusion period. Effective contraception must be used during the trial, and for 4
weeks following discontinuation of the study medication.
- Patients who are willing and able to participate in the full course of the study and
from whom written informed consent has been obtained.
- Multi-organ transplant patients or previous transplant with any other organ different
- The presence of a severe GI disorder. History of a significant GI disorder prior to
transplant that has remained unchanged since transplant and/or the introduction of
MMF will exclude patient.
- Evidence of any GI disorder induced by an infection, underlying medical condition, or
concomitant medication other than MMF.
- Modification of GI medication or MMF dose within last 1 week.
- Evidence of graft rejection, treatment of acute rejection, or unstable renal function
within 4 weeks prior to the Baseline visit.
- Patients who have received an investigational immunosuppressive drug within 4 weeks
prior to study entry.
- Patients with a history of malignancy within the last five years, except excised
squamous or basal cell carcinoma of the skin.
- Pregnant or nursing women.
- Patients with thrombocytopenia (<75,000/mm3), with an absolute neutrophil count of
<1,500/mm3 and/or leukocytopenia (<3,500/mm3), and/or hemoglobin <9.0 g/dL prior to
- Presence of clinically significant pyrexia and/or infection requiring continued
- Evidence of severe liver disease [incl. abnormal liver profile i.e. AST, ALT or total
bilirubin = 3 times the upper limit of normal].
- Patients who have any anatomical GI tract defects which have risk of capsule getting
stuck such as tumor or previous abdominal surgery.
- Abnormal physical or laboratory findings of clinical significance within 2 weeks of
inclusion which would interfere with the objectives of the study.
- Patients with symptoms of significant illness or evidence of current drug and/or
- Inability to self-administer the GSRS & OTE questionnaire.
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5
half-lives of enrollment, whichever is longer.
- History of hypersensitivity to any of the study drugs or to drugs with similar