Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept®

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.