DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Failure, Chronic

Intervention: Thymoglobulin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Johns Hopkins University

Official(s) and/or principal investigator(s):
Robert A Montgomery, M.D., Ph.D., Principal Investigator, Affiliation: Johns Hopkins University , SOM
Christopher E Simpkins, M.D., Study Director, Affiliation: Johns Hopkins University, SOM

Overall contact:
Robert A Montgomery, M.D., Ph.D., Phone: 410-955-7120, Email: rmonty@jhmi.edu

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: 6-month acute cellular and antibody-mediated rejection rate

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Robert A Montgomery, M.D., Ph.D., Phone: 410-955-7120, Email: rmonty@jhmi.edu

The Johns Hopkins University, School of Medicine, Baltimore, Maryland 21205, United States; Recruiting
Robert A Montgomery, M.D., Ph.D., Phone: 410-955-7120, Email: rmonty@jhmi.edu
Vanessa Collins, Phone: 410-955-7120, Email: vcollin2@jhmi.edu
Robert A Montgomery, M.D., Ph.D., Principal 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., Sub-Investigator
Additional Information

Starting date: January 2006
Last updated: May 7, 2008

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017