Status:
COMPLETED
Conversion From Mycophenolate Mofetil to Mycophenolate Sodium in Renal Transplant
Lead Sponsor:
Novartis
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00646737
Start Date
May 1 2008
End Date
December 1 2008
Last Update
February 23 2017
Active Locations (1)
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1
Novartis Investigative Site
São Paulo, Brazil