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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00332839
First received: May 31, 2006
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Renal Transplantation
Drug: Everolimus
Drug: Myfortic and Neoral
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Renal function at Month 12 post transplantation

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 300
Study Start Date: November 2005
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Everolimus
Experimental
Other Name: certican
Active Comparator: 2 Drug: Myfortic and Neoral
active comparator
Other Name: myfortic and neoral

  Eligibility

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

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332839

Locations
Germany
Novartis Investigational Site
Various Cities, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00332839     History of Changes
Other Study ID Numbers: CRAD001ADE02
Study First Received: May 31, 2006
Last Updated: March 6, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
enteric-coated mycophenolate sodium, everolimus, CNI-free regimen

Additional relevant MeSH terms:
Cyclosporine
Sirolimus
Mycophenolic Acid
Mycophenolate mofetil
Everolimus
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 14, 2014