Myfortic or CellCept Gastrointestinal Effects in African American Kidney Recipients

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

Summary

Myfortic (enteric-coated mycophenolate sodium) has been shown to have similar effectiveness to CellCept (mycophenolate mofetil) in preventing rejection in kidney transplant recipients. However, enteric coated mycophenolate sodium has been thought to possibly be associated with fewer gastrointestinal side effects. Mycophenolate mofetil and enteric coated mycophenolate sodium pharmacokinetics (how the drug is absorbed and broken down) have not been well-studied in African American kidney transplant recipients. The investigators are interested in studying enteric coated mycophenolate sodium and mycophenolate mofetil pharmacokinetics and gastrointestinal side effects in African American kidney transplant recipients.

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

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: Novartis Pharmaceuticals
• Treatments: Antilymphocyte Serum; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

Inclusion Criteria:

• Recipients of a deceased donor or living donor kidney transplant

• Recipients of age greater than 18 years but less than 76 years

• African Americans (self-reported patients of Black African descent who live in the United States)

• Willingness to participate in a randomized, clinical trial, as indicated by signed informed consent

• Patients with a history of gastrointestinal complications including any of the following: a history of diarrhea, constipation, acid reflux, or abdominal pain as reported by the patient

• For women of childbearing age, effective contraception must be used before beginning CellCept or Myfortic, during therapy and 6 weeks after therapy has been discontinued (childbearing women should have a negative serum or urine pregnancy test within 1 week prior to starting CellCept or Myfortic therapy)

Exclusion Criteria:

• Recipients with any prior solid organ transplant (including kidney)

• Recipients receiving a concurrent solid organ (heart, liver, pancreas) or cell (islet, bone marrow, stem cell) transplant

• Recipient age is less than 18 years old or greater than 75 years old

• Recipients who are not African American (self-reported patients of Black African descent who live in the United States)

• Recipients on proton pump inhibitor therapy at the time of initial screening (pre-transplant to 2 days post-transplant)

• Recipients with a gastrointestinal bleed within the past three months

• Recipients who are pregnant or breast feeding

• Recipients with known human immunodeficiency virus (HIV) infection

• Allergy to any of the immunosuppressant medications

• Concurrent investigational medication

• Any medical or psychosocial condition, which, in the opinion of the investigators, would hinder compliance with the study requirements

• Inability or unwillingness of patient to provide informed consent