Single Dose Thymoglobulin for Induction in Adult Renal Allograft Recipients
NCT00235781 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2006-10-16
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.
Conditions
- Kidney Transplantation
Interventions
- DRUG
-
Thymoglobulin
Sponsors & Collaborators
-
Washington University School of Medicine
lead OTHER
Principal Investigators
-
Matthew J Koch, MD · Washington University School of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-01-31
- Completion
- 2006-02-28
Countries
- United States
Study Locations
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