A controlled randomized open-label multicentre study evaluatiing if early conversion to everolimus (Certican) from cyclosporine (Neoral) in de novo renal transplant receipients can improve long-term renal function and slow down the progression of chronic allograft nephropathy - CENTRA
- Conditions
- Renal TransplantationMedDRA version: 9.1Level: LLTClassification code 10023438Term: Kidney transplant
- Registration Number
- EUCTR2007-000771-42-DK
- Lead Sponsor
- ovartis Pharma Services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
Male or female above 18 year
first or second renal transplant receipients
willing and capable of giving written informed consent
at randomisation:
maintained on a triple immunosuppresive regime
completed period 1 without experiencing biopsy proven acute rejection
negative pregnancy test and on medically approved birth control metod
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
recipients of multi organ transplants
PRA >30%
receiving renal transplant from HLA-identical sibling
past or present malignancy
receipients of ABO incompatible transplants
at randomisation:
graft loss
hemoglobin count <80g/l and/or platelet count <50x109/l and/or white blood cell count < 2.5 x 109/l)
spot urinary protein/creatinine ratio >150 mg/mmol
requiring dialysis and/or having a cGFR <20ml/min
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method