CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 56 enrolled
Drug / intervention
Thymoglobulin +7 moredrug
Likely dose
Dexamethasone 100 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/NCT00275509
NCT00275509Phase 3Completed

Open Label Randomized Study of Thymoglobulin Versus Daclizumab Induction Therapies for the Reduction of Acute Rejection in Live Donor Kidney Transplant Recipients With a Positive Crossmatch

Johns Hopkins University·interventional·Posted Jan 12, 2006·Updated Jan 18, 2018

In Brief

A Phase 3 clinical trial evaluating Thymoglobulin, Daclizumab, and 6 other interventions for Kidney Failure, Chronic. Completed, enrolled 56 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether the anti-T cell antibody, Thymoglobulin is a more effective induction medication than the anti-IL-2R inhibitor daclizumab, in kidney transplant recipients who have a positive crossmatch with their live donor.

Study Details

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

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 12, 2006
Enrollment StartJan 1, 2007
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 20.5 years ago

Interventions

Thymoglobulindrug

Daclizumabdrug

Plasmapheresisother

Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered

Mycophenolate mofetildrug

2 gm/day. Standard of care

Tacrolimusdrug

To achieve serum level of 8-10 ng/ml.

Dexamethasonedrug

100 mg intra-operatively, and 25 mg every 6h post-operatively for six doses

Prednisonedrug

Taper over three months to 5 mg daily

Cytogamdrug

Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered