Intravenous Immunoglobulin (IVIG) in Lung Transplantation

Phase 2 Completed 11 enrolled Columbia University Grifols Therapeutics LLC · collab

RandomizedCrossoverQuadruple-blindPrevention

Summary

The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent bacterial infections in lung transplant patients with low serum levels of immunoglobulin.

Timeline

Start: 2005-06
Primary completion: 2009-08
Completion: 2010-08

Outcome

Missed primary endpoint

paper IVIG had no effect on the number of bacterial infections during the treatment period PMID 25090414 ↗

Publications

Results Lederer DJ, Philip N, Rybak D, Arcasoy SM, Kawut SM. Intravenous immunoglobulin for hypogammaglobulinemia after lung transplantation: a randomized crossover trial. PLoS One. 2014 Aug 4;9(8):e103908. doi: 10.1371/journal.pone.0103908. eCollection 2014.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Immune Globulin Intravenous (Human)	Protein / enzyme biologic	400 mg/kg	Intravenous