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

NCT00203281 | Withdrawn

• 1 other identifier: 03U.86
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Kidney Transplantation; Plasmapheresis

Keywords

renal transplantation

Interventions

tacrolimus DRUG

mycophenolate mofetil DRUG

daclizumab DRUG

intravenous immune globulin DRUG

plasmapheresis PROCEDURE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital setting

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (2)

Columbia University

New York, New York, 10032, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Tacrolimus; Mycophenolic Acid; Daclizumab; Immunoglobulins, Intravenous; Plasmapheresis

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin G; Immunoglobulin Isotypes; Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Mark Chaballa, PharmD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: February 1, 2003
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 21, 2016

Record last verified: 2016-10

Locations

US (2)