Status:
COMPLETED
Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
De Novo Renal Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 labo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00464399
Start Date
September 1 2006
Last Update
November 16 2016
Active Locations (1)
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1
Novartis Investigative Site,
Oslo, Norway