NCT00908583

Desensitization in Kidney Transplantation

Desensitization for Preformed Anti-HLA Antibodies in Kidney Transplantation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To determine if deletional strategies will provide effective desensitization.

Detailed description

A prospective iterative trial of proteasome inhibitor (PI)-based therapy for reducing HLAantibody (Ab) levels was conducted in five phases differing in bortezomib dosing density and plasmapheresis timing. Phases included 1 or 2 bortezomib cycles (1.3mg/m2,6-8 doses), one rituximab dose and plasmapheresis. HLA Abs were measured by solid phase and flow cytometry (FCM) assays. Immunodominant Ab (iAb) was defined as highest HLA Ab level. Forty-four patients received 52 desensitization courses (7 patients enrolled in multiple phases): Phase 1 (n=20), Phase 2 (n=12), Phase 3 (n=10), Phase 4 (n=5), Phase 5 (n=5).

Conditions

• HLA Sensitization

Interventions

Type	Name	Description
DRUG	plasmapheresis	Patients will receive plasmapheresis 1.5 x plasma volume prior to each Bortezomib dose. Plasma volume replacement will be per physician discretion.
DRUG	Bortezomib	Patients will receive bortezomib as described in protocol
DRUG	Rituximab	Patients will receive rituximab as described in protocol
DRUG	Methylprednisolone	Each bortezomib dose will be preceded by intravenous methylprednisolone (100mg for first two doses and 50mg for following doses).

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2009-05-27
• Last updated: 2016-04-01
• Results posted: 2016-02-26

Locations

2 sites across 1 country: United States