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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 is currently recruiting participants.
Verified January 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00514514
First received: August 9, 2007
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  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:

U.S. FDA Resources

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)

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

Estimated Enrollment: 450
Study Start Date: July 2007
Estimated Primary Completion Date: April 2016 (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 to 70 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514514

Locations
Germany
Universitätsklinikum Charité Recruiting
Berlin, Germany, 10117
Contact: novartis     41613241111        
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00514514     History of Changes
Other Study ID Numbers: CRAD001ADE13
Study First Received: August 9, 2007
Last Updated: January 18, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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 May 19, 2013