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

This study has been withdrawn prior to enrollment.
(funding withdrawn)
Sponsor:
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00203281
First received: September 13, 2005
Last updated: August 23, 2010
Last verified: August 2010
History of Changes
  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 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Estimated Enrollment: 14
Study Start Date: February 2003
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospital setting

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

Locations
United States, New York
Columbia University
New York, New York, United States, 10032
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Mark Chaballa, PharmD Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Mark Chaballa, Thomas Jefferson University Hospital
ClinicalTrials.gov Identifier: NCT00203281     History of Changes
Other Study ID Numbers: 03U.86
Study First Received: September 13, 2005
Last Updated: August 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
renal transplantation

Additional relevant MeSH terms:
Antibodies
Immunoglobulins
Mycophenolate mofetil
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Tacrolimus
Daclizumab
Mycophenolic Acid
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013