Immunophenotyping of Peripheral T Cells After T Cell Depletion With Alemtuzumab
Stopped early · Phase 4
Conditions studied: Kidney Transplant
In brief
The purpose of this study is to check the T and B cells of the immune system in 50 newly transplanted patients whom have received a kidney (50 recipients and 50 donors totaling 100 anticipated participants). This will be done to see how the Standard of Care (SOC) anti-rejection medication, Alemtuzumab (Campath 1-H®) affects these cells- Campath 1-H® reduces the number of T cells produced by one's body.
Key facts
- Study ID
- NCT01213329
- Run by
- Northwestern University
- People needed
- 52
- Starts
- 2006-02-01
- Expected to finish
- 2009-04-01
- Last updated by the study team
- 2019-04-10
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult subjects between ages 18-65 years old of either gender
- Recipients have an available ABO compatible living donor for transplant
- Subjects are listed to be a single-organ transplant recipient (kidney only)
- Subjects have the ability to provide informed consent
You may not qualify if…
- Subjects have panel reactive antibody greater than 35%
- Subjects have the potential to have a high recurrence rate of their primary renal disease (i.e. Focal Segmental Glomerulonephritis )
- Subjects who have a history of Hepatitis C
- Subjects who have had a previous organ transplant
- Subjects are unable to fully understand the purpose of the study, thereby unable to give a fully informed consent
- Subjects with a positive lymphocytotoxic crossmatch using donor lymphocytes and recipient serum
- Subjects who are pregnant or nursing
- Subjects who, due to the existence of a surgical, medical or psychiatric condition, other than the current transplant, which in the opinion of the investigator, precludes enrollment into this trial.
Where it is running
- Northwestern Memorial Hospital — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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