Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept®

Inclusion Criteria:

• Male or female patients between 18 and 75 years of age.
• Recipients of first or second cadaveric, living unrelated or living related kidney transplant.
• Recipients who are at least 4 weeks post renal transplantation with stable renal function.
• 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.

Exclusion Criteria:

• Multi-organ transplant patients or previous transplant with any other organ different from kidney.
• 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 enrollment.
• Presence of clinically significant pyrexia and/or infection requiring continued therapy.
• 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 alcohol abuse.
• 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 chemical structures.