Plasma-Derived C1 Esterase Inhibitor for Acute Antibody Mediated Rejection Following Kidney Transplantation: Results of a Randomized, Double-Blind, Placebo-Controlled Pilot Study.
Montgomery RA, Orandi BJ, et al.American Journal of Transplantation 2016 [record in progress].
Aims
To evaluate the use of human plasma-derived C1 esterase inhibitor (C1 INH) as an add-on therapy to standard of care (SOC) for antibody-mediated rejection (AMR) after kidney transplantation.
Interventions
Patients were randomized to receive either C1 INH, or placebo every other day for 2 weeks (total of seven doses) as adjunct therapy to SOC.
Participants
18 kidney transplant recipients aged ≥ 18 years with adequate function of the current transplant who had an episode of biopsy-proved AMR within 12 months after transplantation.
Outcomes
The primary outcomes measured were day-20 pathology and graft survival. Secondary outcomes measured were discontinuations, graft losses, deaths, and study drug-related serious adverse events.
Follow-up
Day 20
CET Conclusions
This pilot study evaluated the safety and efficacy of Complement (C1) esterase inhibitor as a supplement to the standard treatment of antibody mediated acute rejection (IVIg and plasmapharesis). There were only 9 patients in each arm so the likelihood of demonstrating anything but the greatest of differences was low. There were similar improvements in Banff classification of rejection on biopsies at day 20 and histopathology scores. There were no great differences in adverse effects between the two groups and study drug was not discontinued in any patient. There was only one venous thrombosis in a patient receiving the study drug, although it was associated with an indwelling venous catheter. This was a well conducted study that was placebo controlled and double-blinded and a larger study following on from here is necessary.
Data analysis
Per protocol analysis
Trial registration
ClinicalTrials.gov - NCT01147302