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Single Dose Thymoglobulin for Induction in Adult Renal Allograft Recipients

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. Identifier: NCT00235781
Recruitment Status : Terminated
First Posted : October 10, 2005
Last Update Posted : October 16, 2006
Information provided by:
Washington University School of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Transplantation Drug: Thymoglobulin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 90 participants
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
Study Start Date : January 2006
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Incidence of acute rejection.

Secondary Outcome Measures :
  1. Serious adverse events
  2. renal function
  3. patient and graft survival
  4. infection
  5. PTLD
  6. duration and extent of lymphocyte depletion and immunoassays for evidence of recipient immune response
  7. duration of hospital stay

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT00235781

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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
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Principal Investigator: Matthew J Koch, MD Washington University School of Medicine

Layout table for additonal information Identifier: NCT00235781     History of Changes
Other Study ID Numbers: 05-0783
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: October 16, 2006
Last Verified: October 2006
Keywords provided by Washington University School of Medicine:
Kidney Transplantation
Antilymphocyte Serum
Graft Rejection
Additional relevant MeSH terms:
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Antilymphocyte Serum
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents