Transplant Trial Watch

A Phase I/II, Double-Blind, Placebo-Controlled Study Assessing Safety and Efficacy of C1 Esterase Inhibitor for Prevention of Delayed Graft Function in Deceased Donor Kidney Transplant Recipients.

Jordan SC, Choi J, et al.

American Journal of Transplantation 2018 [record in progress]


Aims
To investigate the safety and efficacy of C1 esterase inhibitor (C1INH) to prevent ischemia reperfusion injury and delayed graft function in deceased donor kidney transplant recipients.

Interventions
Participants were randomized to receive C1INH (50 U/kg), versus placebo, intraoperatively and at 24 hours.

Participants
70 end-stage renal disease patients on dialysis, aged 18-70 years on the United Network for Organ Sharing waitlist awaiting deceased donor kidney transplantation.

Outcomes
The primary outcome measured was the need for hemodialysis during the first week post-transplant. Secondary measured outcomes included patient and graft survival. Adverse events (AEs) and serious AEs were also measured.

Follow-up
1 year

CET Conclusions
This was a moderately well reported, double blinded study. The C1 esterase inhibitor used was associated with fewer dialysis sessions post-operatively than placebo. However, this was not clearly associated with a reduction in DGF (defined as dialysis in the first week, but not first 24 hours after transplantation). The distribution of SAEs was similar between the two groups. The eGFRs were also similar between the two groups. Of concern, the method of randomisation was not clearly described. Ultimately, the study was not large enough to demonstrate a difference in DGF rates, or some of the secondary outcomes but this study does provide a launch pad for further clinical trials targeting this aspect of IRI.

Jadad score
2

Data analysis
Per protocol analysis

Allocation concealment
No

Trial registration
Clinicaltrials.gov - NCT02134314

Funding source
Industry funded