Multicenter, Open-label Study to Assess Whether Treatment With Myfortic®(EC-MPS) Allows Higher Dose Optimization Versus Cellcept® (MMF) Leading to a Dose Reduction of Tacrolimus (Maximiza)

This study is currently recruiting participants.

Verified May 2012 by Novartis

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01056822

First received: January 25, 2010

Last updated: May 7, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 25, 2010

Last Updated Date

May 7, 2012

Start Date ^ICMJE

May 2010

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

to demonstrate that Myfortic® allows higher dose optimization than MMF measured as the percentage of patients who reach at least two dosage step greater than at baseline. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01056822 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To compare efficacy between the two groups of treatment by means of biopsy prove acute rejection (BPAR), graft loss, death and lost to follow up [ Time Frame: 1st month, 3rd month, 5th month, 7th month and 12th month ] [ Designated as safety issue: Yes ]
To compare the quality of life between both immunosuppressive regimens by SIGIT-QoL scale. [ Time Frame: 3th month, 7th month and 12th month ] [ Designated as safety issue: No ]
To compare the safety between both immunosuppressive regimens by adverse events report, vital signs and laboratory analysis results. [ Time Frame: 1st month, 3rd month, 5th month, 7th month and 12th month ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Multicenter, Open-label Study to Assess Whether Treatment With Myfortic®(EC-MPS) Allows Higher Dose Optimization Versus Cellcept® (MMF) Leading to a Dose Reduction of Tacrolimus

Official Title ^ICMJE

Multicenter, Open-label Study to Assess Whether Treatment With Myfortic®(EC-MPS) Allows Higher Dose Optimization Versus Cellcept® (MMF) Leading to a Dose Reduction of Tacrolimus. Maximiza Study

Brief Summary

The objective of the study is to demonstrate that Myfortic® allows higher dose optimization than MMF leading tacrolimus minimization in maintenance renal transplant patients

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Renal Transplant

Intervention ^ICMJE

Drug: Mycophenolate sodium
Mycophenolate sodium
Drug: Mycophenolate mofetil
Mycophenolate mofetil

Study Arm (s)

Experimental: Mycophenolate sodium
Intervention: Drug: Mycophenolate sodium
Active Comparator: Mycophenolate mofetil
Intervention: Drug: Mycophenolate mofetil

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

220

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Received kidney transplant > 1 year and < 5 years prior to study enrollment
Receiving immunosuppressive regimen that includes MMF< 500mg b.i.d. and Tacrolimus (levels >7 in two consecutive visits)
Low immunological risk patients
At least 18 years of age
Willing to provide written informed consent
Able to meet all study requirements including completing questionnaires and completing four study visits

Exclusion Criteria:

Patients with GI symptoms assumed or known not to be caused by MPA therapy (e.g. oral bisphosphonate induced, infectious diarrhoea)
Patients with chronic bowel inflammatory disease
Diabetic patients
Acute rejection < 1 month prior to study enrollment
Woman of child-bearing potential who is planning to become pregnant or is pregnant and/or lactating who is unwilling to use effective means of contraception
Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements
Undergoing acute medical intervention or hospitalization
Any other medical condition that, in the opinion of the site investigator based on recall or chart review would interfere with completing the study
Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Novartis Pharmaceuticals

+41-61-324-1111 ext 0041

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT01056822

Other Study ID Numbers ^ICMJE

CERL080AES08, 2009-014562-26

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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