Conversion From Mycophenolate Mofetil to Mycophenolate Sodium in Renal Transplant

NCT ID: NCT00646737

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2008-12-31

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.

Conditions

Kidney Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Mycophenolate sodium

Group Type: EXPERIMENTAL

Mycophenolate sodium

Intervention Type: DRUG

Mycophenolate sodium

Interventions

Mycophenolate sodium

Mycophenolate sodium

Intervention Type: DRUG

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

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis

Role: STUDY_DIRECTOR

Novartis

Locations

Novartis Investigative Site

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 26398638 (View on PubMed)

Other Identifiers

CERL080ABR02

Identifier Type: -

Identifier Source: org_study_id