Kidney Transplantation
Conditions
Keywords
Kidney transplantation, conversion, mycophenolate mofetil, mycophenolate sodium,, tacrolimus
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 patients in Brazil, in a treatment regimen of immunosuppressants with tacrolimus and mycophenolate mofetil.
Interventions
Mycophenolate sodium
Sponsors
Novartis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastrointestinal symptoms in renal transplant patients treated with the immunosuppression regimen of tacrolimus and mycophenolate at baseline, 8 and 16 weeks | 8 and 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Impact of gastrointestinal symptoms on quality of life. Tolerability of mycophenolate sodium in combination with tacrolimus assessed by OSRS. Safety of mycophenolate sodium in combination with tacrolimus assessed by incidence of adverse events | 8 and 16 weeks |
Countries
Brazil
Outcome results
None listed