NCT01349595

Impact of Proteasome Inhibition on Anti-Donor HLA Antibody Production After Kidney Transplantation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Mark Stegall · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if treating patients who have high levels of donor specific alloantibodies post-transplant with bortezomib might prevent the development of transplant glomerulopathy and preserve allograft function.

Conditions

• Disorder of Transplanted Kidney

Interventions

Type	Name	Description
DRUG	Bortezomib	Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month "hiatus". At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area).

Timeline

• Start date: 2011-12-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2011-05-06
• Last updated: 2015-10-28
• Results posted: 2015-09-09

Locations

1 site across 1 country: United States