Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant Patients
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To evaluate the safety and tolerability of early switch to everolimus from cyclosporine A in de novo renal transplant recipients by assessing rejection rate everolimus trough levels, other safety laboratory variables and adverse events.
Biopsy proven acute rejections or treatment for acute rejections from the time of the conversion from cyclosporine based regimen to a cyclosporine free treatment with everolimus 7 weeks ± 7 days after transplantation until completion of 7 weeks after
Secondary Outcome Measures :
Efficacy assessed by graft and patients survival from the time of conversion 7 weeks ± 7 days until the end of follow-up 12 months after transplantation
Pharmacokinetics assessed by blood samples for everolimus concentration , cyclosporine concentrations
Safety assessed by blood sampling for Hemoglobin, white blood cells (WBC), platelets, s-creatinine, ASAT, ALAT, ALP bilirubin, S-Na, S-K, S-Ca, S-P. S-Urea, S-creatin phosphokinase (S-CPK), u-alb/creatinine ratio
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Male or female aged above 18 years.
Patients having received their first or second single renal transplant from deceased or living donor
Patient willing and capable of giving written informed consent for study participation
Patients treated with as induction therapy at the time of transplantation
Patients maintained on a triple immunosuppressive regime consisting of cyclosporine (C-0 h between 100-250 ng/ml or a C-2 h between 900-1100 ng/ml), Enteric coated mycophenolate sodium (EC-MPS), minimum dose 1080 mg and corticosteroids, minimum dose 10 mg
Patients without any biopsy proven acute rejection episode or treatment for any acute rejection since the transplant
Females capable of becoming pregnant must have a negative pregnancy test prior to the switch to everolimus and are required to practice a medically approved method of birth control for the duration of the study and a period of 8 weeks following discontinuation of study medication, even where there has been a history of infertility.
Recipient of multi-organ transplants, and or previously transplanted with any other organ different from a kidney transplant
Patients with antibodies towards the donor kidney above 30%
Patients receiving a renal transplant from HLA-identical sibling
Presence of hyper sensitivity to drugs similar to everolimus ( e.g. macrolides)
Patient with past (within the last two years) or present malignancy other than excised basal cell or squamous cell carcinoma of the skin
Patients who are recipients of AB0 incompatible transplants
Patients with unsuitable laboratory values
Patients with ongoing wound healing problems or other severe surgical complication in the opinion of the investigator
Patient with a current severe major local or systemic infection
Patients requiring dialysis and/or having a calculated glomerular filtration rate (Cockcroft-Gault) < 20 ml/min
Presence of intractable immunosuppressant complications or side effects (e.g., severe gastrointestinal adverse events) at the time of the switch
Patients who are HIV positive or Hepatitis B surface antigen positive or Hepatitis C virus positive. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C are excluded.
Evidence of severe liver disease
Other protocol-defined inclusion/exclusion criteria may apply.