Belimumab Impacting Transplant Eligibility

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
E. Steve Woodle
Study ID
NCT02500251
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Renal Transplant Rejection

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • belimumab — DRUG
    Belimumab will be administered per study protocol.
  • Bortezomib — DRUG
    Bortezomib will be administered per study protocol.
  • Rituximab — DRUG
    Rituximab will be administered per study protocol.
  • Plasmapheresis — DRUG
    Plasmapheresis will be administered per study protocol.

Study Details

This study is a prospective, open label, phase I/II pilot study.

Key Dates

Start date
Jun 30, 2015
Status verified
Apr 2019
Primary completion
Jun 30, 2018
Completion
Aug 31, 2018

Study Design

Enrollment
11 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group A (5 subjects)
    Subjects will receive bortezomib and plasmapheresis.
  • Experimental: Group B (5 subjects)
    Subjects will receive belimumab, bortezomib, and plasmapheresis.
  • Experimental: Group C (5 subjects)
    Subjects will receive belimumab, bortezomib, rituximab, and plasmapheresis.

Primary Outcome Measure

Efficacy of belimumab as measured by percent reduction in iDSA and/or iAb [ Time Frame: 7 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
The Christ HospitalCincinnatiOhio45219-
University of CincinnatiCincinnatiOhio45267-

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The Christ Hospital· Cincinnati, OHUniversity of Cincinnati· Cincinnati, OH

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