Desensitization Protocol for Highly Sensitized Patients on the Waiting List for Kidney Transplant

Phase 2 Unknown 2 enrolled Seoul National University Hospital Roche Pharma AG · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether high dose IVIG and B cell depleting agents can be used effectively in highly sensitized wait-listed patients.

Timeline

Start: 2010-01
Primary completion: 2014-01
Completion: 2016-01

Outcome

Met primary endpoint

paper Multivariate time-varying covariate Cox regression analysis showed that desensitization increased the probability of DDKT (hazard ratio, 46.895; 95% confidence interval, 3.468-634.132; P = 0.004). PMID 26844479 ↗

paper In conclusion, a desensitization protocol using bortezomib, high-dose IVIG, and rituximab increased the DDKT rate in highly sensitized, wait-listed patients. PMID 26844479 ↗

Publications

Jeong JC, Jambaldorj E, Kwon HY, Kim MG, Im HJ, Jeon HJ, In JW, Han M, Koo TY, Chung J, Song EY, Ahn C, Yang J. Desensitization Using Bortezomib and High-dose Immunoglobulin Increases Rate of Deceased Donor Kidney Transplantation. Medicine (Baltimore). 2016 Feb;95(5):e2635. doi: 10.1097/MD.0000000000002635.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bortezomib	Small molecule	1.3 mg/m2	—
Subject	Rituximab	Monoclonal antibody	375 mg/m2	—
Subject	intravenous immunoglobulin	Protein / enzyme biologic	2 g/kg	Intravenous