The ORTIZ Study: Optimising RASi Therapy with SZC
Research type
Research Study
Full title
A Multi site, placebo controlled, double blind randomised clinical trial evaluating the effectiveness of sodium zirconium cyclosilicate versus placebo to enable safe optimisation of RASi therapy in patients with diabetic kidney disease.
IRAS ID
1003542
Contact name
Kieran McCafferty
Contact email
Sponsor organisation
Barst Health NHS Trust
Eudract number
2020-002988-62
Clinicaltrials.gov Identifier
Research summary
Inhibiting the renin angiotensin (RAS) system has been the cornerstone of therapy for patients with proteinuric CKD for almost 2 decades, to slow the decline in renal function, delay the presence of dialysis and reduce cardiovascular events and death.
Evidence in both the heart and kidney literature suggests that maximising the dose of RASi therapy leads to improved outcomes over smaller doses of RASi.
Up to 80% of patients on RASi therapy are not on maximal therapy, putting them at risk of a more rapid progression and poorer outcomes and increased healthcare costs. An important reason for this is the presence or fear around hyperkalaemia (high potassium).
With reports of significantly increased rate of hyperkalaemia seen following increases in prescribing of RASi therapy.
There is a currently huge unmet need to optimise RASi therapy in those patients with hyperkalaemia.
SZC Sodium zirconium cyclosilicate (zirconium cyclosilicate; also, known as SZC) has been shown to be effective in lowering potassium in patients with heart failure, Diabetes, CKD and RASi therapy.
In the 4-large clinical trials it appears efficacious, well tolerated and safe. The ORTIZ trial will investigate the safety and tolerability of SZC compared to placebo to maximise RASi therapy in patients with diabetes and CKD.
116 patients will be recruited at 4 sites and randomised 1:1 to receive SZC or placebo. Patients will attend 8 visits (screening, baseline, day 7, 14, 28, 42, 56, 84 & FU day 98), and will be in the study for up to 16 weeks, including the screening period (up to 2 weeks), treatment period (12 weeks) and follow up period (2 weeks). The study IMP is SZC/placebo (powder for oral suspension sachets) and the NIMP is Irbesartan. The starting dose of IMP will 5g or 10g, depending on potassium level and will be adjusted at each visit depending on safety tests. Patients will also be taking Irbesartan 0/75/150/300mg oral tablets once a day, depending on safety test results.REC name
West of Scotland REC 1
REC reference
21/WS/0082
Date of REC Opinion
24 Aug 2021
REC opinion
Further Information Favourable Opinion