Single Dose Thymoglobulin for Induction in Adult Renal Allograft Recipients

NCT00235781 | Terminated

• 1 other identifier: 05-0783
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation

Keywords

Kidney Transplantation; Antilymphocyte Serum; Induction; Graft Rejection

Outcome Measures

Primary Outcomes (1)

• Incidence of acute rejection.

Secondary Outcomes (7)

• Serious adverse events

• renal function

• patient and graft survival

• infection

• PTLD

Interventions

Thymoglobulin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Interventions

thymoglobulin

Study Officials

• Matthew J Koch, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2005
• First Posted: October 10, 2005
• Study Start: January 1, 2006
• Study Completion: February 1, 2006
• Last Updated: October 16, 2006

Record last verified: 2006-10

Locations

US (1)