Status:
TERMINATED
Single Dose Thymoglobulin for Induction in Adult Renal Allograft Recipients
Lead Sponsor:
Washington University School of Medicine
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
NA
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, f...
Detailed Description
Induction therapy, using polyclonal or monoclonal antibody preparations as an adjunct immunosuppressive agent during the initial transplant period, has helped to decrease the incidence of acute reject...
Eligibility Criteria
Inclusion
- Patients 18 years of age or older
- All consenting adult renal transplant recipients scheduled to receive induction therapy (deceased donor, living-related, or living-unrelated)
- Females of childbearing age must have a negative pregnancy test performed at the time of admission for transplantation
- Patient or guardian agrees to participate in the study and signs the informed consent.
- No known contraindication to the administration of Thymoglobulin
Exclusion
- A known allergy to rabbit proteins or previous significant intolerance of Thymoglobulin administration
- Pregnant women or nursing mothers
- 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)
- Recipients of a human leukocyte antigen (HLA) identical living donor renal allograft (2-haplotype match)
- Recipients of simultaneous multiple organ transplantation
- Recipients with a pre-existing, non-renal, solid organ transplant
- Recipients of ≥2 previous renal allografts
- 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).
- Any patient who, in the opinion of the investigator, has a significant medical or psychosocial problem that should preclude them from the study.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00235781
Start Date
January 1 2006
End Date
February 1 2006
Last Update
October 16 2006
Active Locations (1)
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1
Washington University School of Medicine/Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110