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Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation

NCT00906204 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2015-12-07

Study results available
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Summary

In a non-blinded pilot study conducted at the University of Nebraska Medical Center, evidence was found that a single large dose of Thymoglobulin on the day of kidney transplantation produced better kidney function than the standard dosing plan, when the same amount is divided into smaller doses on 4 days. This new study repeats that dose comparison, but with double-blinding and at multiple transplantation centers.

Conditions

Interventions

BIOLOGICAL

Single-dose rabbit Anti-thymocyte Globulin induction

6 mg of rATG administered in a single dose on the day of kidney transplantation

BIOLOGICAL

Divided-dose rabbit Anti-thymocyte Globulin induction

6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • University of Arizona

    collaborator OTHER

  • Wake Forest University

    collaborator OTHER

  • University of Nebraska

    collaborator OTHER

  • The Methodist Hospital Research Institute

    collaborator OTHER

  • Wright State University

    lead OTHER

Principal Investigators

  • R.Brian Stevens, MD, PhD · Wright State University, Dayton, Ohio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00906204 on ClinicalTrials.gov