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Comparison of CNI-based Regimen Versus CNI-free Regimen in Kidney Transplant Recipients.

This study is currently recruiting participants.
Verified April 2012 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00332839
First received: May 31, 2006
Last updated: April 28, 2012
Last verified: April 2012
History of Changes

May 31, 2006
April 28, 2012
November 2005
March 2013   (final data collection date for primary outcome measure)
Renal function at Month 12 post transplantation
Same as current
Complete list of historical versions of study NCT00332839 on ClinicalTrials.gov Archive Site
  • Biopsy proven acute rejection, graft loss, death at Month 12
  • Occurrence of treatment failures up to or at Month 12
  • Evolution of renal function between Baseline and Month 12
  • Safety and tolerability at Month 12
  • Changes in cardiovascular risk (according to Framingham Score) between Baseline and Month 12
Same as current
Not Provided
Not Provided
 
Comparison of CNI-based Regimen Versus CNI-free Regimen in Kidney Transplant Recipients.
Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a CNI-free Regimen With Enteric-coated Mycophenolate Sodium and Everolimus in Comparison to Standard Therapy With Enteric-coated Mycophenolate Sodium and Ciclosporin Microemulsion in Stable Renal Transplant Patients

Calcineurin inhibitors (CNI), a potent immunosuppressive drug used in kidney transplant recipients to prevent graft rejection, may cause renal impairment. The aim of this study is to assess whether a CNI-free regimen with enteric-coated mycophenolate sodium and everolimus is as safe and well tolerated as a standard regimen consisting of enteric-coated mycophenolate sodium and cyclosporine microemulsion without a compromise in therapeutic efficacy while resulting in an improved renal function.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Renal Transplantation
  • Drug: Everolimus
    Experimental
    Other Name: certican
  • Drug: Myfortic and Neoral
    active comparator
    Other Name: myfortic and neoral
  • Experimental: 1
    Intervention: Drug: Everolimus
  • Active Comparator: 2
    Intervention: Drug: Myfortic and Neoral
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Not Provided
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Maintenance renal transplant recipients at least 6 months post-transplantation
  • Patients with a serum creatinine < 2,5 mg/dL stable for at least three month (according to the investigator)
  • Patients receiving Myfortic® (Myfortic dose . 720 mg/d) and Sandimmun® Optoral with or without
  • corticosteroids as part of their immunosuppressive regimen for at least 1 month before baseline.

Exclusion Criteria

  • More than one previous renal transplantation
  • Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
  • Patient with proteinuria > 1000 mg/day at baseline

Other protocol-defined exclusion criteria may apply.
Both
18 Years and older
No
Contact: novartis 41 61 324 1111
Germany
 
NCT00332839
CRAD001ADE02
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Novartis
Novartis
April 2012

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