Sodium Zirconium Cyclosilicate and Enhanced Nutrition Study (GRAZE)
Research type
Research Study
Full title
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)
IRAS ID
300410
Contact name
Kieran Mccafferty
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-000457-81
Duration of Study in the UK
0 years, 11 months, 0 days
Research summary
The primary objective of this study is to evaluate the effect of the combination of SZC and enhanced nutritional advice to consume fruit and vegetables as compared to SoC in reducing S-K+.
Approximately 382 participants may take part in this study from approximately 40 sites in UK and US.
This is an Open-Label, Randomised, Controlled, Parallel-Design, Multicentre, Phase IV.
The population studied will be patients with high potassium levels in their blood (hyperkalaemia) and need dialysis (a process of removing extra fluids and waste including potassium their blood).
We are doing this study to better understand the effect of SZC when taken along with two extra portions per day of fresh fruit or vegetables compared to standard of care in patients with high potassium levels undergoing dialysis.
Total duration of study participation for each patient will be approximately 5 months.
The study consists of three phases:
1. Screening: 1 Week (7 Days)2. HK Treatment Phase (all participants take SZC with standard dietary advice): 1 month
3. Diet Comparison Phase (participants are randomised to SoC arm with standard dietary advice or to SZC arm with enhanced dietary advice): 4 months
4. Follow-up: 2 weeks ([14 ± 3 days] to match dialysis schedule)
REC name
London - Harrow Research Ethics Committee
REC reference
21/LO/0630
Date of REC Opinion
18 Oct 2021
REC opinion
Further Information Favourable Opinion