Conversion From Mycophenolate Mofetil to Mycophenolate Sodium in Renal Transplant

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646737
• Other study ID #: CERL080ABR02
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2008
• Last updated: February 21, 2017
• Start date: May 2008
• Est. completion date: December 2008

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Mycophenolate sodium
Mycophenolate sodium

Locations

Country	Name	City	State
Brazil	Novartis Investigative Site	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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 Bra — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Results for CERL080ABR02 from the Novartis Clinical Trials website.