CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 44 enrolled
Drug / intervention
plasmapheresis +3 moredrug
Likely dose
Methylprednisolone 100mgfrom 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/NCT00908583
NCT00908583Phase 4Completed
CompareCT.gov

Desensitization for Preformed Anti-HLA Antibodies in Kidney Transplantation

University of Cincinnati·interventional·Posted May 27, 2009·Updated Apr 1, 2016

In Brief

A Phase 4 clinical trial evaluating plasmapheresis, Bortezomib, and 2 other interventions for HLA Sensitization. Completed, enrolled 44 participants across 2 sites.

Detailed Summary

To determine if deletional strategies will provide effective desensitization.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHLA Sensitization
CountriesUnited States
CollaboratorsMillennium Pharmaceuticals, Inc.

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 27, 2009
Enrollment StartMay 1, 2009
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 17.1 years ago

Interventions

plasmapheresisdrug

Patients will receive plasmapheresis 1.5 x plasma volume prior to each Bortezomib dose. Plasma volume replacement will be per physician discretion.

Bortezomibdrug

Patients will receive bortezomib as described in protocol

Rituximabdrug

Patients will receive rituximab as described in protocol

Methylprednisolonedrug

Each bortezomib dose will be preceded by intravenous methylprednisolone (100mg for first two doses and 50mg for following doses).