Campath, Calcineurin inhibitor reduction and Chronic allograft nephropathy
Not Applicable
Completed
- Conditions
- Kidney transplantationSurgeryFailure and rejection of transplanted organs and tissues
- Registration Number
- ISRCTN88894088
- Lead Sponsor
- niversity of Oxford (UK)
- Brief Summary
1. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25078310 2. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/29226570 (added 18/12/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 394
Inclusion Criteria
1. Men or women aged over 18 years
2. Recipient of kidney transplant from live or deceased donor
Exclusion Criteria
1. Recipients of multi-organ transplants
2. Previous treatment with Campath-1H
3. Active infection
4. Past history of anaphylaxis to humanized monoclonal antibodies
5. History of malignancy (except for adequately treated non-melanoma skin cancer)
6. Loss of previous transplant within 6 months not due to technical reasons
7. Medical history that might limit the participant's ability to take trial treatments for the duration of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Induction therapy comparison: biopsy-proven acute rejection during the first 6 months after transplantation<br> 2. Maintenance therapy comparison: graft function is measured by estimated glomerular filtration rate at 2 years after transplantation<br>
- Secondary Outcome Measures
Name Time Method <br> All secondary outcomes are assessed using a a study-specific questionnaire that has been devised to send to patients and the review of the UK Renal Registry, Hospital Episode Statistics, Office for National Statistics, National Cancer Registry and UK Transplant Registry at 1, 2 and 5 years.<br><br> 1. Graft function and survival<br> 2. Patient survival<br> 3. Incidence of serious infections<br> 4. Incidence of malignancy<br> 5. Major vascular events<br>