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Single Dose Thymoglobulin for Induction in Adult Renal Allograft Recipients

This study has been terminated.
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00235781
First received: October 6, 2005
Last updated: October 13, 2006
Last verified: October 2006
History of Changes
  Purpose

The aim of this trial is to compare the safety and efficacy of a single dose of Thymoglobulin, rabbit derived antithymocyte globulin (Thymoglobulin, SangStat, Fremont, CA) to our standard four dose, four day Thymoglobulin induction regimen from the time of transplantation through a six month follow-up period. The primary endpoint will be the incidence of acute rejection. Secondary endpoints will include serious adverse events, evaluation of renal function, patient and graft survival, incidence of infectious complications, incidence of post-transplantation lymphoproliferative disorder (PTLD), duration and extent of lymphocyte depletion and immunoassays for evidence of recipient immune response to the allograft as well as duration of hospital stay.


Condition Intervention
Kidney Transplantation
 Drug: Thymoglobulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Non-Phased Study of the Use of a Single Dose of Thymoglobulin for Immunosuppressive Induction in Renal Transplant Recipients as Compared to a Standard Four Dose Regimen

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Incidence of acute rejection.

Secondary Outcome Measures:
  • Serious adverse events
  • renal function
  • patient and graft survival
  • infection
  • PTLD
  • duration and extent of lymphocyte depletion and immunoassays for evidence of recipient immune response
  • duration of hospital stay

Estimated Enrollment: 90
Study Start Date: January 2006
Estimated Study Completion Date: February 2006
  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. Patients 18 years of age or older
  2. All consenting adult renal transplant recipients scheduled to receive induction therapy (deceased donor, living-related, or living-unrelated)
  3. Females of childbearing age must have a negative pregnancy test performed at the time of admission for transplantation
  4. Patient or guardian agrees to participate in the study and signs the informed consent.
  5. No known contraindication to the administration of Thymoglobulin

Exclusion Criteria:

  1. A known allergy to rabbit proteins or previous significant intolerance of Thymoglobulin administration
  2. Pregnant women or nursing mothers
  3. Patients with serological evidence of infection with HIV-1, human T-cell leukemia virus type 1 (HTLV-1), or the presence of serum hepatitis B surface antigen (HBsAg)
  4. Recipients of a human leukocyte antigen (HLA) identical living donor renal allograft (2-haplotype match)
  5. Recipients of simultaneous multiple organ transplantation
  6. Recipients with a pre-existing, non-renal, solid organ transplant
  7. Recipients of ≥2 previous renal allografts
  8. Patients with a history of malignancy with evidence of recurrence within 2 years (except adequately treated localized squamous or basal cell carcinoma of the skin).
  9. Any patient who, in the opinion of the investigator, has a significant medical or psychosocial problem that should preclude them from the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235781

Locations
United States, Missouri
Washington University School of Medicine/Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Matthew J Koch, MD Washington University School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00235781     History of Changes
Other Study ID Numbers: 05-0783
Study First Received: October 6, 2005
Last Updated: October 13, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Kidney Transplantation
Antilymphocyte Serum
Induction
Graft Rejection

ClinicalTrials.gov processed this record on May 19, 2013