NCT00906204

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

Prospective, Randomized, Double-Blind, Double-Dummy, Multicenter Trial to Assess Safety of Single Dose vs. Traditional Administration of Thymoglobulin Induction for Renal Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Wright State University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is designed to confirm the one-year safety of single-dose rabbit anti-thymocyte globulin induction at kidney transplantation, compared to the conventional administration of the same overall dose divided into four smaller doses across four days. Two randomized groups of kidney transplant recipients will be each administered the drug Thymoglobulin according to a different dosing regimen. The control group will receive the usual and traditional regimen of a total of 6 mg/Kg divided into 4 doses, 1 on the day of transplantation and 1 each day on the next 3 days. The experimental group will receive the same total Thymoglobulin dose, 6 mg/Kg, but entirely on the day of transplantation. The study will be double-blinded, with placebo doses of Thymoglobulin administered as needed to enrollees in the experimental group. Enrollment is targeted at 165, with 150 subjects needed to complete the study for adequate evaluation.

Conditions

• End-Stage Renal Disease
• Kidney Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-03-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2009-05-21
• Last updated: 2015-12-07
• Results posted: 2015-12-07

Locations

4 sites across 1 country: United States