Welcome to SETS aHUS

SETS aHUS (or Stopping Eculizumab Treatment Safely in aHUS) is a multicentre clinical trial. It is open label, prospective and single arm, and is a non-blinded assessment of the safety and impact of eculizumab withdrawal in patients with atypical haemolytic uraemic syndrome.




To establish an evidence base for an alternative treatment strategy for patients with aHUS that includes the use of Eculizumab to establish remission, safe withdrawal of treatment and the reintroduction of Eculizumab in those patients who relapse.


This study hopes to provide evidence for an alternative strategy for treatment of aHUS based on monitoring and treatment re-introduction rather than continuous Eculizumab treatment. We predict that:

● Possibly over half of patients receiving maintenance Eculizumab treatment could be doing so unnecessarily but there is currently a lack of evidence to support this.

● Withdrawal of drug could lead to a reduction in the burden of treatment (intravenous injections every 2 weeks).

● The potential complications associated with Eculizumab use could be avoided.

● A system of surveillance will be needed to detect relapse early for rapid re-initiation of treatment to avoid complications associated with untreated relapse.


We are planning to recruit 30 participants to withdraw from Eculizumab and 20 participants to complete health economics and lifestyle questionnaires but these participants will continue to receive their usual Eculizumab treatment. Recruitment is due to start in May 2018 and will take place in 20 Renal secondary care units, located across the UK, who are using Eculizumab to treat patients with aHUS. Patients with atypical haemolytic uraemic syndrome who are receiving Eculizumab therapy may be eligible to take part in the study and if they do, they will have continuous monitoring of adverse events. The treatment withdrawal period will take place over 24 months and there will then be an additional 24 months of follow up. Patients will be assessed regularly for evidence of disease relapse for the 2 year follow up period and by self monitoring analysis recorded in patient diaries. In total, participants in the study will attend 34 clinic visits which is less than their standard care appointments when taking Eculizumab.

MANAGEMENT OF DISEASE RELAPSE Any patient with a suspected relapse will be reported to the doctor in charge of the study at the local hospital and the National aHUS Service. When a relapse is diagnosed patients will restart Eculizumab treatment within 24 hours of presentation. Patients who relapse and require re-introduction of Eculizumab treatment will remain on treatment under follow up for the full 2 years of the study.

IN CASE OF RELAPSE If a participant feels unwell, however minor the illness, they should report urgently to their local medical team or GP. They will be evaluated immediately by obtaining U&E, FBC and LDH laboratory investigations to ascertain if they need to re-start their Eculizumab treatment and prophylactic antibiotics as soon as possible and WITHIN 24hrs. If the results are abnormal, please call +44 (0)191 233 6161 and ask for the aHUS on-call consultant as per the EMERGENCY REFERRALS pathways that can be found on the website.