Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant Patients
Phase 3
Completed
- Conditions
- De Novo Renal Transplantation
- Registration Number
- NCT00464399
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Novartis Investigative Site,
🇳🇴Oslo, Norway