An Open-Label, Randomised, Controlled, Parallel-Design, Multicentre, Phase IV Study of Sodium Zirconium Cyclosilicate and Enhanced Nutrition Advice Compared to Standard of Care in Dialysis Patients with Hyperkalaemia (GRAZE)
Sodium Zirconium Cyclosilicate (SZC)
18 Years - 130 Years
Endpoint Classification: -
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Verified 01 Dec 2022 by AstraZeneca
No locations available
|Experimental: SZC arm with enhanced dietary advice|
Participants will continue taking Sodium Zirconium Cyclosilicate (SZC), which can be titrated up or down to maintain S-K+ in the range 3.5-5.5 mmol/L; participants will also receive enhanced nutritional advice to consume fruit and vegetables. Advice will be provided by dietitians at study visits and by Noom app between visits.
Drug: Sodium Zirconium Cyclosilicate (SZC)
Participants in the active arm will receive SZC dosed as per the local label to control hyperkalaemia and maintain normokalaemia.
Other Name: SZC
Other: Enhanced dietary advice
Participants will receive enhanced dietary advice in addition to taking SZC. This will include advice from dietitians to consume fruit and vegetables. Participants will be encouraged to consume up to 70 mmol K+ per day.
Other Name: Enhanced dietary advice
|Other: SoC arm with standard dietary advice|
SZC will be withdrawn and participants will receive SoC as per site practice, including dietary K+ restriction. Dietary advice will be given by dietitians at study visits and by Noom app between study visits.
Other: Standard dietary advice including K+ restriction.
Participants randomised to the SoC arm of the Diet Comparison Phase will receive standard dietary advice including K+ restriction.
Other Name: Standard dietary advice