Conversion From Mycophenolate Mofetil to Mycophenolate Sodium in Renal Transplant

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00646737
First received: March 18, 2008
Last updated: May 7, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
Drug: Mycophenolate sodium
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Study of Enteric-coated Mycophenolate Sodium in Combination With Tacrolimus in Renal Transplant Patient

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Gastrointestinal symptoms in renal transplant patients treated with the immunosuppression regimen of tacrolimus and mycophenolate at baseline, 8 and 16 weeks [ Time Frame: 8 and 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 8 and 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: May 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Mycophenolate sodium
Drug: Mycophenolate sodium
Mycophenolate sodium

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646737

Locations
Brazil
Novartis Investigative Site
Sao Paulo, Brazil
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00646737     History of Changes
Other Study ID Numbers: CERL080ABR02
Study First Received: March 18, 2008
Last Updated: May 7, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Novartis:
Kidney transplantation
conversion
mycophenolate mofetil
mycophenolate sodium,
tacrolimus

Additional relevant MeSH terms:
Mycophenolate mofetil
Tacrolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014