Status:
COMPLETED
Efficacy and Safety of Everolimus With Enteric-Coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion-free Regimen Compared to Standard Therapy in de Novo Renal Transplant Patients
Lead Sponsor:
Novartis
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess whether a calcineurin inhibitor (CNI)-free regimen with enteric-coated mycophenolate sodium (EC-MPS) and everolimus is as safe and well-tolerated as the standard...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- The following inclusion criteria had to be present at BL 1 (Screening visit prior to transplantation):
- Males or females, aged 18 - 65 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 BL 1, 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
- Of all patients included into the study at BL 1 (prior to transplantation), those who continued into the randomized study period had to meet the following condition at BL 2, prior to randomization:
- Patients had to be on an immunosuppressive regimen with EC-MPS (target dose; 1440 mg/day, if tolerated; minimal dose: 720 mg/day), cyclosporine and corticosteroids
- Patients with an actual serum creatinine =\< 3.0 mg/dl
- Exclusion Criteria:
- The following exclusion criteria must not be present at BL 1 (Screening visit prior to transplantation):
- More than one previous renal transplantation
- Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
- Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
- Patients who are recipients of A-B-O incompatible transplants
- Patients with a historical or current peak PRA of \> 25%
- Patients with already existing antibodies against the HLA-type of the receiving transplant
- Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
- Of all patients included into the study at BL 1 (prior to transplantation), those who met one or more of the following criteria at BL 2, prior to randomization, should not continue into the randomized study period:
- Graft loss or death
- Changes to the immunosuppressive regimen prior to randomization due to immunologic reasons
- Patients who suffered from severe rejection (\>= BANFF II acute rejection), recurrent acute rejection, or steroid resistant acute rejection
- Proteinuria \> 1g/day
- Other protocol-defined exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00154310
Start Date
June 1 2005
End Date
September 1 2008
Last Update
November 13 2013
Active Locations (3)
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1
Novartis Investigational Sites
Nuremberg, Germany
2
Novartis Pharma AG
Basel, Switzerland
3
Novartis Investigational Sites
Bern, Switzerland