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Single Dose Thymoglobulin for Induction in Adult Renal Allograft Recipients

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00235781
First Posted: October 10, 2005
Last Update Posted: October 16, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Washington University School of Medicine
  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
Intervention Model: Parallel Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00235781     History of Changes
Other Study ID Numbers: 05-0783
First Submitted: October 6, 2005
First Posted: October 10, 2005
Last Update Posted: October 16, 2006
Last Verified: October 2006

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

Additional relevant MeSH terms:
Thymoglobulin
Antilymphocyte Serum
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents