Single Dose Thymoglobulin for Induction in Adult Renal Allograft Recipients

Not Applicable

Terminated

• Conditions: Kidney Transplantation

• Registration Number: NCT00235781
• Lead Sponsor: 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 acu...

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 rejection significantly. In the 1980's acute rejection occurred in approximately 50% of renal transplant recipients. In the current era of transplantation, the combin...

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2005-10-06
• Study First Submitted QC: 2005-10-06
• Study First Posted: 2005-10-10
• Study Start: 2006-01
• Study Completion: 2006-02
• Status Verified: 2006-10
• Last Update Submitted: 2006-10-13
• Last Update Posted: 2006-10-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 90

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of acute rejection.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Washington University School of Medicine/Barnes-Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States