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
  Purpose

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


Condition Intervention Phase
Renal Transplant
Drug: Mycophenolate sodium
Drug: Mycophenolate mofetil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 220
Study Start Date: May 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mycophenolate sodium Drug: Mycophenolate sodium
Mycophenolate sodium
Active Comparator: Mycophenolate mofetil Drug: Mycophenolate mofetil
Mycophenolate mofetil

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01056822

Locations
Spain
Novartis Investigative Site Barcelona
Barcelona, Spain
H. Clinico de San Carlos (Madrid)
Madrid, Spain
Hospital Son Dureta
Mallorca, Spain
Hospital Central de Asturias
Oviedo, Spain
Clinica Universitaria de Navarra
Pamplona, Spain
Hospital Universitario
Valencia, Spain
Hospital Clinico Universitario
Valladolid, Spain
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01056822     History of Changes
Other Study ID Numbers: CERL080AES08, 2009-014562-26
Study First Received: January 25, 2010
Last Updated: February 12, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Novartis:
Renal transplant
Gastrointestinal Symptoms
Optimization
Minimization
biopsy proven acute rejection (BPAR)
graft loss
death
lost to follow up
quality of life
SIGIT-QoL

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 26, 2014