Recombinant Human C1 Inhibitor for the Treatment of Early Antibody-Mediated Rejection in Renal Transplantation

Summary

The purpose of this study will be to assess the safety, tolerability, and efficacy of rhC1INH in renal transplant recipients with biopsy-confirmed antibody-mediated rejection (AMR) within 30 days of renal transplantation. This study will combine the investigational drug rhC1INH with a standard regimen of plasmapheresis (PP) and intravenous immune globulin (IVIG) and compare this to PP and IVIG alone.

Timeline

Start

2010-12

Primary completion

2011-12

Completion

2011-12

Outcome

Outcome not reported

Stopped: “Recent improvements in clinical practice have reduced the apparent incidence of AMR in renal transplantation.”

Drugs

Indications