Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study to Evaluate Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant

Conditions
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De Novo Renal Transplantation

Intervention / Treatment
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* Drug: everolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: everolimus|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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De novo renal transplantation, CNI-free protocol, adults, everolimus, rejections