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

This study is currently recruiting participants.

Verified by Thomas Jefferson University, May 2008

Sponsored by:	Thomas Jefferson University
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00203281

Purpose

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.

Condition	Intervention	Phase
Kidney Transplantation Plasmapheresis	Drug: tacrolimus Drug: mycophenolate mofetil Drug: daclizumab Drug: intravenous immune globulin Procedure: plasmapheresis	Phase IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Tacrolimus Immunoglobulins Globulin, Immune Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Tacrolimus anhydrous Dacliximab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Pharmacokinetic Evaluation of Plasmapheresis in Cross Match Positive or ABO Incompatible Kidney Allograft Recipients

Further study details as provided by Thomas Jefferson University:

Estimated Enrollment:	14
Study Start Date:	February 2003
Estimated Study Completion Date:	May 2009

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203281

Contacts

Contact: Mark Chaballa, PharmD

215-955-5335

mark.chaballa@jeffersonhospital.org

Locations

United States, New York
Columbia University	Not yet recruiting
New York, New York, United States, 10032
Contact: Lloyd Ratner, MD 212-342-3539 lr2182@columbia.edu
Principal Investigator: Lloyd Ratner, MD
United States, Pennsylvania
Thomas Jefferson University Hospital	Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Mark Chaballa, PharmD 215-955-5335 mark.chaballa@jeffersonhospital.org
Principal Investigator: Mark Chaballa, PharmD

Sponsors and Collaborators

Thomas Jefferson University

Investigators

Principal Investigator:

Mark Chaballa, PharmD

Thomas Jefferson University Hospital

More Information

Responsible Party:	Thomas Jefferson University Hospital ( Mark Chaballa )
Study ID Numbers:	03U.86
Study First Received:	September 13, 2005
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00203281
Health Authority:	United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:

renal transplantation

Study placed in the following topic categories:

Antibodies
Immunoglobulins, Intravenous
Daclizumab
Mycophenolate mofetil

Rho(D) Immune Globulin
Tacrolimus
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009