Conversion From Mycophnolate Mofetil to Mycophenolate Sodium in Renal Transplant - Full Text View

Purpose

The purpose of this study is to evaluate the safety and the tolerability of the substitution of mycophenolate mofetil for enteric-coated mywphenolate 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 IV

MedlinePlus related topics:

Kidney Transplantation

ChemIDplus related topics:

Tacrolimus Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Mycophenolate sodium Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Phase IV Study of Enteric-Coated Mycophenoiate Sodium in Combition With Tacrolimus in Renal Transplant Patient

Further study details as provided by Novartis:

Primary Outcome Measures:

Gastrointestinal symptoms in rend tromsplmt patients treated with the immunosuppression regimen of tacrolimus and mycophenolate at baseline, 8 wd 16 weeks [ Time Frame: 8 and 16 wks ] [ 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 ans 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	168
Study Start Date:	March 2008
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Mycophenolate sodium	Drug: Mycophenolate sodium Mycophenolate sodium

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

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 rnofetil (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 cIinical investigation in the last 6 months before the present study;
Thrombocytopenia (platelets <75,00O/mm3), leucopenia (total leukocytes <4,000/mm3)a ndlor 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 my 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

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

Contacts


Contact: Novartis	41613241111

Locations


Brazil
	Novartis Investigative Site	Not yet recruiting
	Sao paulo, Brazil
	Contact: Novartis 41613241111

Sponsors and Collaborators

Novartis

Investigators


Study Director:	Novartis	Novartis

More Information

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CERL080ABR02
First Received:	March 18, 2008
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00646737
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Novartis:

Kidney transplantation, conversion, mycophenolate rnofetil, mycophenolate sodium,

tacrolimus.

Study placed in the following topic categories:

Mycophenolate mofetil

Tacrolimus

Additional relevant MeSH terms:

Immunologic Factors

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 14, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00646737