Conversion From Mycophenolate Mofetil to Mycophenolate Sodium in Renal Transplant

Study Overview
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Brief Summary
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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.

Official Title
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Phase IV Study of Enteric-coated Mycophenolate Sodium in Combination With Tacrolimus in Renal Transplant Patient

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: Mycophenolate sodium


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Mycophenolate sodium | Drug: Mycophenolate sodium<br>* Mycophenolate sodium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney transplantation, conversion, mycophenolate mofetil, mycophenolate sodium,, tacrolimus