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
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: 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 July 22, 2014