Clinical trial NCT00646737: Conversion From Mycophenolate Mofetil to Mycophenolate Sodium in Renal Transplant
Official title: Phase IV Study of Enteric-coated Mycophenolate Sodium in Combination With Tacrolimus in Renal Transplant Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: Kidney transplantation
conversion
mycophenolate mofetil
mycophenolate sodium,
tacrolimus
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Gastrointestinal symptoms in renal transplant patients treated with the immunosuppression regimen of tacrolimus and mycophenolate at baseline, 8 and 16 weeks
timeFrame: 8 and 16 weeks
Secondary outcomes:
measure: 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
timeFrame: 8 and 16 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Pacheco e Silva Filho A, Manfro RC, Contieri FL, Mazzali M, Garcia VD, Carvalho Dde B, David S, Machado P, Rodrigues CA. Evaluation of tolerability of enteric-coated mycophenolate sodium versus mycophenolate mofetil in de novo renal transplantation. J Bras Nefrol. 2015 Jul-Sep;37(3):291-6. doi: 10.5935/0101-2800.20150048. English, Portuguese.