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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01056822
First received: January 25, 2010
Last updated: February 12, 2014
Last verified: February 2014

January 25, 2010
February 12, 2014
May 2010
April 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01056822 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Transplant
  • Drug: Mycophenolate sodium
    Mycophenolate sodium
  • Drug: Mycophenolate mofetil
    Mycophenolate mofetil
  • Experimental: Mycophenolate sodium
    Intervention: Drug: Mycophenolate sodium
  • Active Comparator: Mycophenolate mofetil
    Intervention: Drug: Mycophenolate mofetil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01056822
CERL080AES08, 2009-014562-26
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2014

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