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Quantitating the Impact of Plerixafor

NCT02522572 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-06-30

No results posted yet for this study

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.

Conditions

  • Transplants and Implants

Interventions

DRUG

plerixafor

Plerixafor will be dosed subcutaneously and administered based on group assignment.

DRUG

Bortezomib

Bortezomib will be given via IV push over 3-5 seconds and administered based on group assignment.

OTHER

plasmapheresis

Plasmapheresis will be administered based on group assignment.

Sponsors & Collaborators

  • Sanofi-Synthelabo

    collaborator INDUSTRY

  • E. Steve Woodle

    lead OTHER

Principal Investigators

  • Ervin S Woodle, MD · University of Cincinnati

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2020-09-30
Completion
2020-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02522572 on ClinicalTrials.gov