Text Size

A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Regimen Versus a Standard Regimen in de Novo Heart Transplant Recipients

This study is currently recruiting participants.
Verified April 2012 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00862979
First received: March 16, 2009
Last updated: April 28, 2012
Last verified: April 2012
History of Changes
  Purpose

This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while both treatments are expected to be comparable with respect to efficacy.


Condition Intervention Phase
Heart Transplantation
 Drug: MMF OR Myfortic, Certican®, Sandimmun® optoral
Drug: Sandimmun Optoral, Certican
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 15-month, Multi-center, Randomized, Open-label, Parallel Group Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Regimen (Everolimus and Mycophenolic Acid) Versus a Standard Regimen (Cyclosporine A and Everolimus) in de Novo Heart Transplant Recipients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Renal function assessed as glomerula filtration rate (GFR) - MDRD formula [ Time Frame: 18 months after heart transplantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of treatment failures [ Time Frame: up to or at Month 18 ] [ Designated as safety issue: Yes ]
  • incidence of major cardiac events and each of its compoments [ Time Frame: Month 18 ] [ Designated as safety issue: Yes ]
  • renal function by GFR - Cockcroft-Gault method [ Time Frame: Month 12 and 18 ] [ Designated as safety issue: No ]
  • renal function and evolution of renal function (creatinine slope) [ Time Frame: between Month 6 and Month 18 ] [ Designated as safety issue: No ]
  • safety and tolerability [ Time Frame: Month 6, 9 and 18 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: February 2009
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
MMF OR Myfortic, Certican®, Sandimmun® optoral
 Drug: MMF OR Myfortic, Certican®, Sandimmun® optoral
Mycophenolic Acid + Everolimus + corticosteroids
Experimental: 1
Cyclosporine A + Everolimus + corticosteroids
 Drug: Sandimmun Optoral, Certican
CNI-group

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Heart transplantation, 3 months prior to enrolment
  • Patients have to receive an immunosuppressive regimen with Sandimmun® Optoral, Certican® and corticosteroids
  • Sufficient graft function
  • Sufficient renal function
  • Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at baseline, 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

Exclusion criteria:

  • Multi-organ recipients, re-transplantation, or previous transplant with any other organ.
  • Patients who are recipients of A-B-O incompatible transplants
  • Cold ischemia time >6 hours
  • Historical or current peak PRA of > 25% at time of transplantation
  • Already existing antibodies against the HLA-type of the receiving transplant Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862979

Contacts
Contact: Novarts Pharmaceuticals 862-778-8300

Locations
Germany
DHZ Berlin Recruiting
Berlin, Germany, 13353
Contact: Elke Wenzel     030-4593 2203        
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00862979     History of Changes
Other Study ID Numbers: CRAD001ADE14
Study First Received: March 16, 2009
Last Updated: April 28, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Heart Transplantation
Cardiac Transplantation
CNI-sparing
renal function
 CNI
Cyclosporine A
Everolimus
enteric coated mycophenolic acid

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

ClinicalTrials.gov processed this record on May 16, 2013