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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Cyclosporine; Cyclosporins; Everolimus; Sirolimus

Criteria

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.