drugset / Trial / NCT02522572

Quantitating the Impact of Plerixafor

NCT02522572

Phase 1/2 Unknown 12 enrolled E. Steve Woodle Sanofi-Synthelabo · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

The primary objective of this study is to conduct a proof of concept pilot study that will provide a preliminary evaluation of the safety of plerixafor alone or in combination with bortezomib on plasma cell mobilization, Human Leukocyte Antigen (HLA) antibody levels and toxicity profile in sensitized patients awaiting kidney transplantation. The secondary objective of this study is to conduct additional analyses of the study regimen on HLA antibody levels using multiple different assays and statistical analysis.

Timeline

Start
2015-08
Primary completion
2020-09
Completion
2020-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule Intravenous
Subject Plerixafor Small molecule Subcutaneous

Indications

No indication recorded.