A comparison of Sirolimus versus Tacrolimus as a delayed treatment of recipients of non heart beating donor kidneys after anti-IL2 monoclonal antibody - Sirolimus vs Tacrolimus for NHBD Kidney Recipients after IL-2 mAb
Phase 1
- Conditions
- Kidney transplantation from non heart beating donors for end-stage renal disease
- Registration Number
- EUCTR2006-001265-41-GB
- Lead Sponsor
- ewcastle upon Tyne Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Recipients of kidneys from non heart beating donors
Age 18-75
Written informed consent obtained from the patient after receiving a comprehensive explanation
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
Exclusion Criteria
Pregnant women
Recipients of multiple transplants (e.g. Both kidneys from one donor transplanted into one recipient or a simultaneous kidney and liver or kidney and pancreas transplant)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effects of sirolimus and tacrolimus on kidney function following non heart beating donor kidney transplantation into adult recipients.;Secondary Objective: To determine if the drugs have different effects on patient survival, survival of the transplanted kidney, acute rejection, chronic rejection and complications following surgery.;Primary end point(s): The primary end points are creatinine and calculated GFR (glomerular filtration rate) at monthly intervals from the date of transplant to 12 months.
- Secondary Outcome Measures
Name Time Method