Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept®
Condition: Gastrointestinal Lesions; Signs and Symptoms, Digestive
MeSH terms: Signs and Symptoms, Digestive
Intervention: Small bowel capsule endoscopy (SBCE); myfortic
Intervention description: SBCE will be performed at Day 2 and Day 30.; switching from mycophenolate mofetil to mycophenolic acid on equimolar basis
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Renal transplant recipients; Gastrointestinal findings in small bowel capsule endoscopy; Mycophenolic acid; Mycophenolate Mofetil; Mycophenolate Sodium

Summary:

      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).
    

Eligibility criteria:

        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.