Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia

Stopped early · Phase 4

Conditions studied: Hyperkalaemia

In brief

Prescribing Sodium zirconium cyclosilicate (SZC) with enhanced nutritional advice to participants with hyperkalaemia on haemodialysis will reduce serum K+ (S-K+ ) and enable the consumption of more fruit and vegetables and more satisfying diet. The study aims to show that participants using SZC achieve S-K+ reduction as well as participants on SoC (other than K+ binders), without the need for restricting K+ in the diet.

Key facts

Study ID

NCT04997161

Run by

AstraZeneca

People needed

3

Starts

2021-08-17

Expected to finish

2021-11-17

Last updated by the study team

2023-01-19

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must be ≥18 years of age at the time of signing the informed consent.
• Participants with prevalent HK (S-K+ >5.5 mmol/L at the end of LIDI) not requiring acute treatment.
• Receiving haemodialysis 3 times a week with stable vascular access for at least 3 months before screening visit.
• Participants who have and are able and willing to use smart phone (android or iOS) nutrition app.
• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Female participants of childbearing potential must have a negative pregnancy test.
• Female participants must be 1 year post-menopausal, surgically sterile, or using 1 highly effective form of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly). They should have been stable on their chosen method of birth control for a minimum of 3 months before entering the study and willing to remain on the birth control until 12 weeks after the last dose.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in the protocol.

You may not qualify if…

• As judged by the investigator or sponsor, any medical condition (including active, clinically significant infection) that may pose a safety risk to the participant in this study, may confound safety or efficacy assessments and jeopardise the quality of data, or may interfere with study participation.
• Myocardial infarction, acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina), stroke, seizure, thrombotic/thromboembolic event (eg, deep vein thrombosis or pulmonary embolism, but excluding vascular access thrombosis), percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within 12 weeks prior to screening visit.
• Severe leucocytosis (>20 × 109 /L) or thrombocytosis (≥450 × 109 /L) during screening.
• Polycythaemia (haemoglobin >14 g/dL) during screening.
• Severe constipation, bowel obstruction, post-operative motility disorders.
• Scheduled date for living donor kidney transplant.
• Participants with a life expectancy of less than 6 months.
• Females of childbearing potential, unless using contraception as detailed in the protocol or sexually abstinent.
• Currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
• Presence of cardiac arrhythmias or conduction defects that require immediate treatment at HCP discretion.
• History of alcohol or drug abuse within 2 years prior to screening visit.
• History of QT prolongation associated with other medications that required discontinuation of that medication.
• Congenital long QT syndrome or QT interval corrected for heart rate (QTc) using Fridericia's method (QTcF) >550 ms.
• Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.
• If the participant has evidence of Coronavirus disease 2019 (COVID-19) within 2 weeks prior to screening (see Appendix D), the participant cannot be enrolled in the study.
• Participants treated with SZC, sodium polystyrene sulfonate (SPS: Kayexalate™; Resonium™ A), calcium polystyrene sulfonate (CPS: Calcium Resonium™), or patiromer (Veltassa™) 1 within 4 weeks before screening.
• Participants with a known hypersensitivity or previous anaphylaxis to SZC or any of the excipients of the product.
• Participants unable to take oral SZC. Prior/Concurrent Clinical Study Experience
• Participation in another clinical study with an investigational product administered during the month before screening2 .
• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
• Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
• Previous enrolment in the present study.

Where it is running

• Research Site — West Palm Beach, Florida, United States

Full record on ClinicalTrials.gov

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