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Clinical Trials/ISRCTN72965183
ISRCTN72965183CompletedNot Applicable

Does conversion from Mycophenolate Mofetil (CellCept) to Enteric-coated Mycophenolate Sodium (Myfortic) improve gastrointestinal symptoms in pediatric renal transplant recipients?

ovartis Pharmaceuticals Canada Inc.0 sites32 target enrollmentStarted: January 11, 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
32

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

Inclusion Criteria

  • 1. Children, 7-20 years of age, with renal transplant whose current immunosuppression includes MMF
  • 2. Female patients of childbearing age who agree to maintain effective birth control practice during the study
  • 3. Patient has a functioning renal transplant for at least 3 months and with stable renal function
  • 4. The patient, or in case the patient is minor, the patient's parent(s) or their legal representative, has been fully informed and has given written informed consent to participate in the study. If the minor is in the position to comprehend the nature, significance and scope of the study and to determine his decision accordingly, then his written consent shall also be required. Witnessed informed consent is accepted in case the patient (if not a minor) is capable of making the decision but not capable of signing the document.

Exclusion Criteria

  • 1. Current maintenance immunosuppression does not include Mycophenolate Mofetil
  • 2. The patient has developmental delay or a syndrome that would not allow him or her to complete the GSRS questionnaire
  • 3. Patient with malignancy or history of malignancy
  • 4. Gastrointestinal symptoms not related to MMF (i.e. Infectious diarrhea)
  • 5. Patient has significant, uncontrolled concomitant infections or other serious medical conditions (For example, uncontrolled diabetes or peptic ulcers)
  • 6. Patient is participating or has participated in another clinical trial and/or is taking or has been taking an investigational drug in the past 28 days

Investigators

Sponsor
ovartis Pharmaceuticals Canada Inc.

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