A prospective, open, randomized, single center study comparing the effects of duo therapy with Everolimus and steroids versus triple treatment of low dose calcineurin inhibitor, low-dose MMF and steroids at least one year after renal transplantation.Effects on renal function, tolerability, chronic allograft damage, cardiovascular parameters and malignancies. - STER
- Conditions
- Renal transplantation.
- Registration Number
- EUCTR2009-014436-38-NL
- Lead Sponsor
- MCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 130
•Female or male, aged between 18 and 70 years.
•Recipient of a kidney graft from a deceased donor or living (non-HLA identical) donor.
•The patient understands the purpose and risks of the study and has given written informed consent to participate in the study.
•Acceptable renal function, eGFR > 40 ml/min, Proteinuria = 1, 0 g/24hr.
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
•Patients with multi-organ transplants.
•Patients who have been receiving a second or subsequent transplant.
•Patients with very low function at 1 year post-transplant, GFR < 40.
•Proteinuria > 1, 0 g/24 hr.
•Patients with a screening/baseline total white blood cell count < 2,0 10Eg/l or ANC < 1,0 10Eg/l, platelet count < 100 10Eg/l.
•Patients with baseline fasting triglycerides > 4.5 mmol/l or fasting total cholesterol > 7.8 mmol/l despite optimal lipid-lowering therapy.
•Presence of sub clinical rejection (Borderline or Banff score >1a) in biopsy taken at approximately month 12
•Vascular or Acute rejection (Banff score = 2a) six months preceding randomization.
•Female patients who are pregnant or unwilling to use adequate contraception during the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: ;Primary end point(s): •Renal function<br>•The percentage of patients that need reconversion to their original therapy (tolerability).<br><br>;Main Objective: <br>To investigate the safety and efficacy of a therapy consisting Everolimus and <br>corticosteroids maintenance immunosuppressive regime twelve months after renal transplantation <br>in recipients of donor kidney graft on graft function and acute rejection rates. The other group will<br>receive a low-dose regimen consisting a low-dose calcineurin inhibitor, low dose MMF and corticosteroids. <br>
- Secondary Outcome Measures
Name Time Method