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Proteasome Inhibitor
Group A for Transplant/Implant
Phase 1 & 2
Waitlist Available
Led By Ervin S Woodle, MD
Research Sponsored by E. Steve Woodle
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 44 days
Awards & highlights
Study Summary
This trial will test the safety of a new drug combo to help kidney transplant patients with HLA antibodies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 44 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 44 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent reduction in immunodominant Donor Specific Antibody (iDSA) [highest titer DSA (MFI)] and/or immunodominant antibody (iAb)
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group CExperimental Treatment3 Interventions
6 doses of plerixafor, 2 doses of bortezomib, and plasmapheresis
Group II: Group BExperimental Treatment3 Interventions
4 doses of plerixafor, 1 dose of bortezomib, and plasmapheresis
Group III: Group AExperimental Treatment2 Interventions
4 doses of plerixafor and plasmapheresis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bortezomib D-mannitol
FDA approved
Plerixafor
FDA approved
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Who is running the clinical trial?
E. Steve WoodleLead Sponsor
2 Previous Clinical Trials
43 Total Patients Enrolled
Sanofi-SynthelaboIndustry Sponsor
49 Previous Clinical Trials
34,654 Total Patients Enrolled
Ervin S Woodle, MDPrincipal InvestigatorUniversity of Cincinnati
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