Conversion From Mycophenolate Mofetil to Mycophenolate Sodium in Renal Transplant

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and the tolerability of the substitution of mycophenolate mofetil for enteric-coated mycophenolate sodium in a population of stable renal transplant patients in Brazil, in a treatment regimen of immunosuppressants with tacrolimus and mycophenolate mofetil.

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

Details

• Lead Sponsor: Novartis
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

Inclusion criteria

• Age between 18 and 65 years;

• First or second renal transplant within at least 12 weeks;

• Clinical stability, in the opinion of the investigator, during at least 8 weeks before inclusion in the study;

• Women of reproductive age must use contraceptive methods and present negative results in pregnancy test Serum creatinine < 2.5 mg/dE; Patients in use of a immunosuppression regimen based on tacrolimus and mycophenolate mofetil (generic or not, in any dose), who present gastrointestinal symptoms Capacity to complete the study requirements;

Exclusion criteria History of acute rejection,

• Proven or not by biopsy, in the last 2 months before the study;

• Recipients of multiple organs;

• Participation in any clinical investigation in the last 6 months before the present study;

• Thrombocytopenia (platelets <75,00O/mm3), leucopenia (total leukocytes <4,000/mm3)and/or anemia (hemoglobin <9.0 gldL) before inclusion in the study;

• Clinically important disease, in the opinion of the investigator, including systemic infection, within 2 weeks before inclusion in the study;

• Presence of any neoplasia, current or past, except resected basal cell carcinoma;

• Any surgical or medical condition that could significantly alter the absorption, distribution, metabolism or excretion of medicines or that could put the patient in danger as a result of participation in the study;

• History of drug or alcohol abuse within previous 12 months of inclusion in the study, Current or prior use in the last 2 months of bile acid-adsorbing resins(cholestyramine and colestipol).