EMPIRIKAL-2
Research type
Research Study
Full title
A multi-centre, multi-arm, double-blind randomised placebo-controlled dose finding trial investigating the safety and Efficacy of MirococePt (APT070) In Reducing delayed graft function In the Kidney ALlograft
IRAS ID
1008476
Contact name
Theodoros Kasimatis
Contact email
Sponsor organisation
Guy's and St Thomas' NHS Foundation Trust
ISRCTN Number
ISRCTN14279222
Research summary
Up to half of kidney transplant patients are diagnosed with delayed graft function (DGF). DGF is when a donor kidney does not work straight away after transplant. The donor organ undergoes a lack of blood supply after organ retrieval. Following reintroduction of blood flow upon transplantation the local complement system reacts. This is a set of inflammatory proteins that play a critical role in the development of DGF. Patients who develop DGF are more likely to reject the transplanted kidney. DGF can also contribute to reduced kidney transplant survival and to prolonged hospitalisation. Thus, a treatment that can help prevent DGF is important.
The EMPIRIKAL-2 trial is evaluating the effect of a drug called Mirococept. The study aims to identify the best dose for the drug to help protect against DGF. Treatment of the donor kidney with Mirococept will occur before transplantation. Mirococept is retained in the donor kidney where it targets the complement system. So, systemic impact of the drug is expected to be limited.
The study will recruit eligible patients on the kidney transplant register. Recruitment will take place at NHS hospital centres in the UK. Initially, 9 participants will be recruited to assess preliminary safety. Three different doses will be tested. If successful, enrolment of a further 144 participants will be undertaken. Allocation to one of four different treatment groups will be at random. They will receive a kidney treated with Mirococept at one of three doses or with a standard solution. There will be blinding (concealment) of treatment allocation during this stage. Participant follow-up is for 12 months after transplantation. This will be during routine clinical follow-up (no extra appointments). There will be some collection of research blood and optional tissue samples. All other tests/procedures will be as per routine care.
The Medical Research Council is funding the trial.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
24/NE/0071
Date of REC Opinion
13 May 2024
REC opinion
Further Information Favourable Opinion