A randomised prospective trial of tacrolimus-based steroid avoidance in renal transplantation with either alemtuzumab induction or, basiliximab induction and mycophenolate mofetil maintenance therapy - SALAMI

Phase 1

Conditions: MabCampath / Alemtuzumab will be used as part of the immunosuppression regime following renal transplant.

Registration Number: EUCTR2006-000830-11-GB

Lead Sponsor: eeds Teaching Hospitals NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

•Male and female patients who must be over age 18 years.
•Patients must be recipients of heart-beating cadaveric, non-heart beating or living donors.
•Patients receiving a 2nd or subsequent grafts must have maintained their primary graft for a minimum of 6 months, except if graft failure was due to technical reasons.
•Written Informed consent
•Women at risk of pregnancy must have a negative pregnancy test before commencing the trial and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuing the trial. The manufacturer of Alemtuzumab advises effective contraception for 6 months after administration to men or women. Advice will be given to patients to discuss with the transplant medical staff if a pregnancy is planned.

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

•Regional patients from Hull Royal Infirmary (due to the logistical difficulties in following these patients up from Leeds).
•High Risk Recipients - defined as recipients who have one or more of the following; 2 HLA-DR mismatch, previous immunologically mediated graft loss in less than 6 months, Preoperative donor specific antibodies
•Known hypersensitivity to the IMP including the standard drugs.
•Prohibited prior or concomitant medications
•Pregnant women or nursing mothers.
•WBC count < 3000/mm3 or platelets < 75,000/mm3 at time of study entry
•Any other concurrent cardiovascular, gastrointestinal, pulmonary or haematological conditions that would restrict the administration of study drugs in the opinion of the investigator.