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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by Johns Hopkins University.
Recruitment status was:  Recruiting
Information provided by:
Johns Hopkins University Identifier:
First received: January 10, 2006
Last updated: May 7, 2008
Last verified: May 2008
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
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00275509

Contact: Robert A Montgomery, M.D., Ph.D. 410-955-7120
Contact: Vanessa Collins 410-955-7120

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   
Contact: Vanessa Collins    410-955-7120   
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
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 Identifier: NCT00275509     History of Changes
Other Study ID Numbers: 05-06-29-03
Study First Received: January 10, 2006
Last Updated: May 7, 2008

Keywords provided by Johns Hopkins University:
positive crossmatch
antibody mediated rejection

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic processed this record on May 24, 2017