Transplant Trial Watch

A Randomized Clinical Trial of Anti-IL-6 Antibody Clazakizumab in Late Antibody-Mediated Kidney Transplant Rejection.

Doberer, K., et al.

Journal of the American Society of Nephrology 2020; 32(3):708-722.


Aims
The aim of this study was to assess the efficacy and safety of clazakizumab, an anti-interleukin-6 (IL-6) antibody, in late antibody-mediated renal transplant rejection (ABMR).

Interventions
Participants were randomised to either the clazakizumab group or the placebo group.

Participants
20 adult kidney transplant recipients.

Outcomes
The primary outcome was the evaluation of safety and tolerability. The secondary outcome was the analysis of efficacy.

Follow-up
52 weeks

CET Conclusions
The pilot randomised, double-blind, controlled trial investigated the safety and tolerability of clazakizumab and its efficacy in late antibody-mediated rejection (ABMR) in kidney transplantation. Twenty kidney transplant recipients with DSA-positive ABMR after a median of 10.6 years post-transplantation were randomised to clazakizumab or placebo according to an allocation sequence. The 12-week study period was followed by a 40-week open-label extension in which all participants received clazakizumab. Four patients (three patients receiving clazakizumab) experienced serious adverse events during the 12-week study period and nine patients during the open-label extension. There were two cases of diverticulitis. The authors stress the need for patient selection and monitoring and suggest that the preliminary efficacy data would need validation in a larger trial with longer term follow up.

Jadad score
5

Data analysis
Per protocol analysis

Allocation concealment
Yes

Trial registration
European Union Drug Regulating Authorities Clinical Trials Database - 2017–001604–30; ClinicalTrials.gov - NCT03444103

Funding source
Non-industry funded