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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 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

January 10, 2006
May 7, 2008
January 2006
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6-month acute cellular and antibody-mediated rejection rate
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Complete list of historical versions of study NCT00275509 on ClinicalTrials.gov Archive Site
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Induction Therapy Study in Live Donor Kidney Transplant Recipients With a Positive Crossmatch
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Kidney Failure, Chronic
Drug: Thymoglobulin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
January 2010
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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
Both
18 Years and older
No
Contact: Robert A Montgomery, M.D., Ph.D. 410-955-7120 rmonty@jhmi.edu
Contact: Vanessa Collins 410-955-7120 vcollin2@jhmi.edu
United States
 
NCT00275509
05-06-29-03
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Johns Hopkins University
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Principal Investigator: Robert A Montgomery, M.D., Ph.D. Johns Hopkins University , SOM
Study Director: Christopher E Simpkins, M.D. Johns Hopkins University, SOM
Johns Hopkins University
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP