Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Calcineurin Inhibitor (CNI)-Free Regimen and a CNI-low Dose Regimen

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00514514
First received: August 9, 2007
Last updated: March 23, 2016
Last verified: March 2016
  Purpose
The purpose of this study is to compare renal function of immunosuppressive regimens with different relevance of the calcineurin inhibitor (CNI) cyclosporine: standard dose CNI, low dose CNI, CNI free in de novo kidney transplant patients after 12 months of therapy.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-center, Open-label, Prospective, Randomized, Parallel Group, Long-term Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a CNI-free Regimen and a CNI-low Dose Regimen

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Renal function assessed by glomerular filtration rate (GFR) - Nankivell method - 12 months after renal transplantation (Tx) [ Time Frame: 48 Mth ] [ Designated as safety issue: Yes ]
    The primary objective of this trial is to demonstrate superiority of a CNI-free regimen respect to the renal function at Month 12 post Tx assessed by glomerular filtration rate - Nankivell method - as compared to the standard regimen in de novo kidney transplant patients.


Secondary Outcome Measures:
  • Renal function glomerular filtration rate M12 post by serum creat.at M12 post Tx Efficacy(biopsy proven acute ejection,graft loss,death) at M6&M12 Occurrence treatment failures up to or at M12, Evolution of renal function between M3&M12 creatinine slope [ Time Frame: 48 Mth ] [ Designated as safety issue: Yes ]

Enrollment: 756
Study Start Date: July 2007
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Everolimus
experimental
Other Name: Certican
Active Comparator: Arm 2 Drug: Myfortic and Neoral
active comparator

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Males or females, aged 18 - 70 years
  • Recipients of de novo cadaveric, living unrelated or living related kidney transplants
  • Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at screening, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility.
  • Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.

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
  • Patients receiving a kidney from a non-heart beating donor
  • Donor age: < 5 years or > 70 years
  • Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
  • Other protocol-defined inclusion/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: NCT00514514

Locations
Germany
Novartis Investigative Site
Aachen, Germany, 52074
Novartis Investigative Site
Berlin, Germany, 10117
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Erlangen, Germany, 91054
Novartis Investigative Site
Essen, Germany, 45122
Novartis Investigative Site
Frankfurt am Main, Germany, 60596
Novartis Investigative Site
Freiburg, Germany, 79106
Novartis Investigative Site
Hamburg, Germany, 20246
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Hannover Muenden, Germany, 34346
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Kaiserslautern, Germany, 67655
Novartis Investigative Site
Koeln, Germany, 51109
Novartis Investigative Site
Lubeck, Germany, 23538
Novartis Investigative Site
Munchen, Germany, 81377
Novartis Investigative Site
München, Germany, 81675
Novartis Investigative Site
Regensburg, Germany, 93053
Switzerland
Novartis Investigative Site
Bern, Switzerland, 3010
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Novartis
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00514514     History of Changes
Other Study ID Numbers: CRAD001ADE13  2006-007021-32 
Study First Received: August 9, 2007
Last Updated: March 23, 2016
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Everolimus
mycophenolate
CNI-free
kidney transplantation

Additional relevant MeSH terms:
Everolimus
Sirolimus
Mycophenolate mofetil
Calcineurin Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2016