CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 99 enrolled
Drug / intervention
Single-dose rabbit Anti-thymocyte Globulin induction +1 morebiological
Likely dose
Single-dose rabbit Anti-thymocyte Globulin induction 6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00906204
NCT00906204Phase 2Completed

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

Wright State University·interventional·Posted May 21, 2009·Updated Dec 7, 2015

In Brief

A Phase 2 clinical trial evaluating Single-dose rabbit Anti-thymocyte Globulin induction and Divided-dose rabbit Anti-thymocyte Globulin induction for End-Stage Renal Disease and Kidney Failure. Completed, enrolled 99 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 21, 2009
Enrollment StartMar 1, 2010
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 17.1 years ago

Interventions

Single-dose rabbit Anti-thymocyte Globulin inductionbiological

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

Divided-dose rabbit Anti-thymocyte Globulin inductionbiological

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.