None listed
Conditions
Brief summary
The purpose of this study is to determine the safe and potential cardiac (heart) benefit of using Certican (Registered Trademark) in kidney transplantat patients in combination with Neoral (Registered Trademark) (cyclosporine A), corticosteroids (methylprednisone/prednisone) and myfortic (Registered Trademark) (mycophenolate) with or without Simulect (Registered Trademark). The main goal is to reduce the risk of heart disease. Certican (Registered Trademark), Neoral (Registered Trademark), Simulect (Registered Trademark), corticosteroids and myfortic (Registered Trademark) are all anti-rejection treatments.
Interventions
Everolimus - available in 0.25mg, 0.5mg and 0.75mg tablets. Typical dose amount is 1.5mg orally twice daily and adjusted to keep target therapeutic levels as specified in protocol. Duration of up to 18 months post-kidney transplant.
Sponsors
Heath Department of Western Australia
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females aged 18-65 years inclusive. 2. Recipients of cadaveric, living unrelated or living related donor kidney transplants. 3. Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at screening, and are required to practice a medically accepted effective method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility. 4. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.
Exclusion criteria
1. Patients who are recipients of multiple organ transplants, kidney and pancreas, or previous transplant with any organ other than kidney but excluding recipients receiving two kidneys from the same donor. 2. Patients receiving tumour-resected kidneys, kidneys from non-heart beating donors or deceased donor >65 years and/or with terminal creatinine (of deceased-donor) of =150micromol/Litre (umol/L). 3. Patients at high immunological risk of graft loss, indicated by peak panel reactive antibody (PRA) >50% or loss of a previous renal allograft within the first 6 months of transplantation due to acute rejection. 4. Presence of any severe allergy or hypersensitivity to drugs similar to Certican (Registered Trademark) (e.g. macrolides) or Neoral (Registered Trademark). 5. Patients who are recipients of A-B-O blood group incompatible transplants or complement-dependent cytotoxicity (CDC) T or B cell cross-match positive transplants. Patients with documented donor-specific antibodies are not excluded if allogeneic complement-dependent cytotoxicity (CDC) cross-match pre-transplant is negative. 6. Patients who are known to have chronic active Hepatitis C, or who are human immunodeficiency virus (HIV) or Hepatitis B surface antigen positive. Laboratory results obtained within 6 months prior to randomization are acceptable. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C are excluded. 7. Body mass index (BMI) >35kg/m2. 8. Patients with symptoms of significant somatic or mental illness, or inability to co-operate or communicate with the investigator. 9. Unresolved history of drug or alcohol abuse. 10. Patients with clinically significant infections requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus that in the opinion of the investigator would interfere with the appropriate conduct of the study. 11. Patients with a history of malignancy (other than excised basal cell carcinoma of the skin). 12. Breastfeeding women. 13. Abnormal physical or laboratory findings of clinical significance, which at investigator discretion would interfere with the objectives of the study.
Outcome results
None listed