Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept®

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborator: Novartis
• Treatments: Mycophenolate mofetil; Mycophenolic Acid

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.