Status:
COMPLETED
A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Heart Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Heart transplantation, 3 months prior to enrollment
- 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
Exclusion
Key Trial Info
Start Date :
February 24 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2017
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT00862979
Start Date
February 24 2009
End Date
March 6 2017
Last Update
August 7 2018
Active Locations (9)
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1
Novartis Investigative Site
Bad Oeynhausen, Germany, 32545
2
Novartis Investigative Site
Berlin, Germany, 13353
3
Novartis Investigative Site
Hamburg, Germany, 20246
4
Novartis Investigative Site
Hanover, Germany, 30625