CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Thymoglobulin +1 moredrug
Likely dose
Thymoglobulin 0.75mg/kg dosefrom 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/NCT01280617
NCT01280617N/ACompleted

Low Dose Thymoglobulin As Induction Agent on Prednisone-Free Regimens of Renal Transplant Recipients

Lahey Clinic·interventional·Posted Jan 21, 2011·Updated Mar 16, 2021

In Brief

A clinical study evaluating Thymoglobulin and Thymoglobulin 0.75mg/kg dose for Acute Renal Failure. Completed, enrolled 44 participants across 1 site.

Detailed Summary

This is a planned single center prospective randomized study evaluating the safety and efficacy of low dose thymoglobulin as induction agent in renal transplant recipients. Inclusion criteria will be adult renal transplant recipients who are not sensitized against their potential donors. The patients who agree to participate in the study will be randomly assigned to either thymoglobulin at 1.25mg/kg x 3 doses or 0.75mg/kg x 3 doses. There will be 86 sealed envelopes to perform the randomization process. 43 envelopes with 1.25mg/kg dosing and the other 43 envelopes with 0.75mg/kg dosing. The investigators will sequentially choose the sealed envelopes at the time of the patient randomization process. All patients will be started on our standard immunosupression regimen of prograf/cellcept and a fast steroid taper. Data will be obtained from every patient for up to one year post-transplant.

Study Details

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

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 21, 2011
Enrollment StartOct 1, 2010
Primary CompletionNov 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.4 years ago

Interventions

Thymoglobulindrug

Thymoglobulin 1.25mg/kg dose

Thymoglobulin 0.75mg/kg dosedrug

Thymoglobulin