Induction Therapy Study in Live Donor Kidney Transplant Recipients With a Positive Crossmatch

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00275509
First received: January 10, 2006
Last updated: May 7, 2008
Last verified: May 2008
  Purpose

The purpose of this study is to determine whether the anti-T cell antibody, Thymoglobulin is a more effective induction medication than the anti-IL-2R inhibitor daclizumab, in kidney transplant recipients who have a positive crossmatch with their live donor.


Condition Intervention Phase
Kidney Failure, Chronic
Drug: Thymoglobulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Open Label Randomized Study of Thymoglobulin Versus Daclizumab Induction Therapies for the Reduction of Acute Rejection in Live Donor Kidney Transplant Recipients With a Positive Crossmatch

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 6-month acute cellular and antibody-mediated rejection rate

Estimated Enrollment: 110
Study Start Date: January 2006
Estimated Study Completion Date: January 2010
Detailed Description:

Kidney transplantation is widely recognized as the optimal therapy for the management of end-stage renal disease. Presently, the deceased donor kidney waiting list has expanded disproportionately with the number of transplant procedures that are performed in the United States. To further compound this problem, as many as 1/3 of the patients on this list are highly sensitized against a broad range of potential donors.

In order to address this problem, we developed an antibody depletion protocol that permits transplantation in patients who have a positive crossmatch with their live donor. The protocol consists of standard immunosuppressant therapy, plasmapheresis, and intravenous immunoglobulin infusion. We have successfully performed transplantation in over 100 such patients with low complication rates.

Because these patients have been exposed to their donor's HLA antigen they are at high risk for both acute cellular and acute antibody-mediated rejection. This intent of this prospective, randomized, open-label trial is to determine whether induction therapy (i.e. therapy given at the time of transplantation for prophylaxis) with Thymoglobulin is associated with a lower 6-month incidence of acute cellular and antibody-mediated rejection than with our standard therapy, daclizumab.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (18 years or older)
  • End-stage renal disease
  • Identified to have positive lymphocytotoxic crossmatch or flow cytometric crossmatch with live donor

Exclusion Criteria:

  • Deceased donor recipients
  • Pregnancy
  • Active infection
  • History of cancer within the past two years (with the exception of non-melanomatous skin cancer)
  • History of heparin induced thrombocytopenia
  • Medical contraindications to transplant procedure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275509

Contacts
Contact: Robert A Montgomery, M.D., Ph.D. 410-955-7120 rmonty@jhmi.edu
Contact: Vanessa Collins 410-955-7120 vcollin2@jhmi.edu

Locations
United States, Maryland
The Johns Hopkins University, School of Medicine Recruiting
Baltimore, Maryland, United States, 21205
Contact: Robert A Montgomery, M.D., Ph.D.    410-955-7120    rmonty@jhmi.edu   
Contact: Vanessa Collins    410-955-7120    vcollin2@jhmi.edu   
Principal Investigator: Robert A Montgomery, M.D., Ph.D.         
Sub-Investigator: Andrea A Zachary, Ph.D.         
Sub-Investigator: Christopher E Simpkins, M.D.         
Sub-Investigator: Mary S. Leffell, Ph.D.         
Sub-Investigator: Mark Haas, M.D., Ph.D.         
Sub-Investigator: Daniel Warren, Ph.D.         
Sub-Investigator: Jayme Locke, M.D.         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Robert A Montgomery, M.D., Ph.D. Johns Hopkins University , SOM
Study Director: Christopher E Simpkins, M.D. Johns Hopkins University, SOM
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00275509     History of Changes
Other Study ID Numbers: 05-06-29-03
Study First Received: January 10, 2006
Last Updated: May 7, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
kidney
transplantation
positive crossmatch
antibody mediated rejection
rejection
induction
therapy
trial

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on October 19, 2014