De Novo Renal Transplantation
Conditions
Keywords
De novo renal transplantation, CNI-free protocol, adults, everolimus, rejections
Brief summary
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.
Interventions
DRUGeverolimus
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | 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
| Measure | 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 | — |
Countries
Norway
Outcome results
None listed