Kidney Transplantation Clinical Trial
Official title:
Pharmacokinetic Evaluation of Plasmapheresis in Cross Match Positive or ABO Incompatible Kidney Allograft Recipients
Verified date | October 2016 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
Based on the limited amount of experience with plasmapheresis and CytoGam concomitant use, the researchers seek to evaluate the pharmacokinetics (drug absorption, distribution, and elimination) of this therapy. The researchers are also interested in evaluating the pharmacokinetics of the various immunosuppressant medications that patients will receive such as tacrolimus, mycophenolate mofetil and daclizumab.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patient is a male or female. - Age of 18-75. - Patient must have the ability to provide informed consent. - Positive cross-match with intended donor and/or ABO incompatible with intended donor. Exclusion Criteria: - Patients under the age of 18 or over the age of 75. - Women that are currently pregnant. - Patient has a history of any illness that, in the opinion of the investigator(s), might confound the results of the study or pose additional risk to the patient. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Columbia University | New York | New York |
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Cancer Center at Thomas Jefferson University |
United States,
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