Study to Evaluate the Amount of Medications That May be Removed From the Body During Plasmapheresis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00203281
• Date of registration: 13/09/2005
• Primary sponsor: Thomas Jefferson University
• Public title: Study to Evaluate the Amount of Medications That May be Removed From the Body During Plasmapheresis
• Scientific title: Pharmacokinetic Evaluation of Plasmapheresis in Cross Match Positive or ABO Incompatible Kidney Allograft Recipients
• Date of first enrolment: February 2003
• Target sample size: 14
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00203281
• Study type: Observational
• Study design: Observational Model: Case-Only, Time Perspective: Prospective

Countries of recruitment

United States

Contacts

• Name: Mark Chaballa, PharmD
• Affiliation: Thomas Jefferson University

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Kidney Transplantation

Plasmapheresis

Intervention(s)

Drug: daclizumab

Drug: intravenous immune globulin

Drug: mycophenolate mofetil

Drug: tacrolimus

Procedure: plasmapheresis

Secondary ID(s)

03U.86

Source(s) of Monetary Support

Please refer to primary and secondary sponsors