At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 40 enrolled
Drug / intervention
Rabbit Antithymocyte Globulin +2 moredrug
Likely dose
Rabbit Antithymocyte Globulin 1.5mg/kgfrom 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.
Targeted Therapy for High Immunologic Risk Renal Transplant Recipients: A Prospective, Randomized, Open-Label Pilot Study of B-Cell Depleting Therapy in Combination With Anti-Thymocyte Globulin [Rabbit] (Thymoglobulin®, Genzyme), Tacrolimus (Prograf®, Astellas), Mycophenolate Mofetil (CellCept®, Roche) and Corticosteroid Minimization
In Brief
A Phase 4 clinical trial evaluating Rabbit Antithymocyte Globulin, Velcade, and 1 other intervention for Kidney Transplantation. Completed, enrolled 40 participants across 2 sites.
Detailed Summary
The purpose of this research study is to find out the effects of adding B lymphocyte modulating agents in patients at risk for rejection receiving an anti-rejection (immunosuppressive) regimen of Thymoglobulin® induction with Prograf®, Cellcept® and corticosteroid therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplantation
CountriesUnited States
CollaboratorsMillennium Pharmaceuticals, Inc., Genzyme, a Sanofi Company
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2008
First PostedOct 2008
Primary CompletionFeb 2013
Study CompletionMar 2013
TodayJul 2026
First PostedOct 31, 2008
Enrollment StartSep 1, 2008
Primary CompletionFeb 1, 2013
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 17.7 years ago
Interventions
Rabbit Antithymocyte Globulindrug
rATG will be given 1.5mg/kg intravenous (IV) per dose.
Velcadedrug
Velcade will be given 1.3mg/m2 via intravenous push (IVP) per dose.
Rituxandrug
Given via IV per group assignment.