NCT02500251

Belimumab Impacting Transplant Eligibility

Belimumab-Based Plasma Cell Targeted Therapy to Impact Transplant Eligibility

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: E. Steve Woodle · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study is a prospective, open label, phase I/II pilot study. For Treatment Groups A and B, the duration of study will include a 5 month enrollment period and approximately 7 months of follow-up. For Treatment Group C, the duration of study will include a 3 month enrollment period and approximately 7 months of follow-up.

Conditions

• Renal Transplant Rejection

Interventions

Type	Name	Description
DRUG	belimumab	Belimumab will be administered per study protocol.
DRUG	Bortezomib	Bortezomib will be administered per study protocol.
DRUG	Rituximab	Rituximab will be administered per study protocol.
DRUG	Plasmapheresis	Plasmapheresis will be administered per study protocol.

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-06-01
• Completion: 2018-08-01
• First posted: 2015-07-16
• Last updated: 2019-04-22

Locations

2 sites across 1 country: United States