None listed
Conditions
Brief summary
The purpose of the study is to compare, following kidney transplantation, the safety and efficacy of alemtuzumab (MABCAMPATH) and low-dose tacrolimus (CAMPATH group) versus standard dose of tacrolimus with Azathioprine and Steroids (STANDARD group)
Interventions
For CAMPATH Group, the intervention is administration of 2 doses of alemtuzumab 20 mg intravenously, 1st dose within 6 hours post anastomosis and 2nd dose 24 hours after 1st dose, followed by treatment with low-dose Tacrolimus (oral tablets twice daily for 3 years) adjusted to Trough levels of 5-7 ng/mL for duration of trial. Patients will be followed up for 3 years after transplantation surgery.
Sponsors
National University Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
- Aged 18 – 65 years - Renal failure with no previous renal transplantation - Cadaveric or live donor kidney transplant recipient - Written informed consent given
Exclusion criteria
- Pregnant or nursing or woman of child bearing potential unwilling/unable to practice an acceptable form of birth control - Major systemic or other illness that would, in the opinion of the investigator, interfere with the patient’s ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of study results - Multi-organ transplant recipient - Prior renal transplants - Previous treatment with alemtuzumab - Patient requiring anti-lymphocyte preparations/interleukin receptor antibody preparations for induction therapy - Patient requiring cyclosporine, mycophenolic acid analogues or Mammalian Target of Rapamycin (mTOR) inhibitors as initial therapy - Use of other investigational agents within 6 weeks prior to transplantation - Active systemic infection - Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen or anti-hepatitis C antibody positive (if Hepatitis C Virus Polymerase Chain Reaction (HCV PCR) unavailable) or Hepatitis C Virus Polymerase Chain Reaction (HCV PCR) positive - Positive T lymphocyte cytotoxicity cross-match between recipient serum and donor cells - Autoimmune hemolytic anemia - Past history of anaphylaxis following exposure to humanised monoclonal antibodies - Panel Reactive Antibodies (PRA) equal or greater than 50% - Inability to undergo transplant biopsy, including patient who will require anticoagulation - Cold ischemia time greater than 24 hours - Patient whose graft function or perfusion cannot be demonstrated within 5 hours post-anastomosis.
Outcome results
None listed