IVIG/Rituximab vs Rituximab in Kidney Transplant With de Novo Donor-specific Antibodies

Phase 4 Completed 50 enrolled Seoul National University Hospital GC Biopharma Corp · collab Severance Hospital · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

The objective of this study was to compare two strategies of de novo donor specific antibodies (DSA) and antibody-mediated rejection (AMR) prevention in renal transplant recipients: high dose intravenous immunoglobulin (IVIG)/rituximab regimens versus rituximab alone.

Timeline

Start: 2019-01-08
Primary completion: 2021-12-31
Completion: 2022-05-03

Publications

Kim HW, Lee J, Heo SJ, Kim BS, Huh KH, Yang J. Comparison of high-dose IVIG and rituximab versus rituximab as a preemptive therapy for de novo donor-specific antibodies in kidney transplant patients. Sci Rep. 2023 May 11;13(1):7682. doi: 10.1038/s41598-023-34804-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous
Comparator	intravenous immune globulin	Protein / enzyme biologic	2 g/kg	Intravenous

Indications

No indication recorded.