Removal Of Cyclosporine With Everolimus On Inflammation And Vascular Endpoints
- Conditions
- Cardiovascular riskRenal and Urogenital - Kidney diseaseCardiovascular - Diseases of the vasculature and circulation including the lymphatic systemCardiovascular - Hypertension
- Registration Number
- ACTRN12610000320055
- Lead Sponsor
- Heath Department of Western Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 28
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vascular function determined by pulse wave velocity and aortic augmentation index using SphymaCor system (Registered Trademark)[3, 6, 12 and 18 months post-transplant]
- Secondary Outcome Measures
Name Time Method Metabolic:<br><br>Blood analysis (serum/plasma) for glucose, lipids, C-reactive protein (CRP) and pro-inflammatory cytokines<br><br>Sphygmomanometer for measurement of blood pressure[3, 6, 12 and 18 months post-transplant];Proteinuria by urine analysis (immunoassay)[3, 6, 12 and 18 months post-transplant];Cardiac function determined by echocardiography[3 and 18 months post-transplant];Glomerular filtration rate[3, 6, 12 and 18 months post-transplant];Cardiovascular outcomes:<br>1) History for details of hospitalisations for cardiovascular-related events (using medical records)<br>2) Blood analysis for cholesterol level[3, 6, 12 and 18 months post-transplant];Transplant outcomes (rejection, graft and patient survival)[3, 6, 12 and 18 months post-transplant];Kidney allograft biopsy (to look for evidence of rejection, scarring, drug toxicity)[3 and 18 months post-kidney transplant]