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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-17

Study Completion Date

2021-11-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease

NCT04727528

Hyperkalaemia Metabolic Acidosis Chronic Kidney Disease

TERMINATED PHASE3

Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study

NCT05347693

Hyperkalaemia Chronic Kidney Disease

COMPLETED PHASE4

Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4

NCT06365684

Hyperkalemia Diet Modification Chronic Kidney Disease +1 more

RECRUITING PHASE4

A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)

NCT03283267

Hyperkalemia

COMPLETED PHASE1

SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients

NCT06029179

Hyperkalemia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a Phase IV, randomised, controlled, open-label, parallel-group, multicentre, prospective study 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+ levels in participants with hyperkalaemia on haemodialysis. Following 7-day screening, all participants who are enrolled will begin an up to 1-month HK Treatment Phase with SZC as per local label. Participants will receive dietary advice consistent with SoC at that site, including K+ restriction. A 4-month Diet Comparison Phase will begin next with participants being randomised to either continue taking SZC, which can be titrated as needed to maintain target S-K+ , and receive enhanced nutritional advice to consume fruit and vegetables (SZC arm), or SZC will be withdrawn and participants will receive SoC, including dietary K+ restriction (SoC arm).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperkalaemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel: Participants are assigned to two groups in parallel for the duration of the study.

Following 7-day screening, all participants who are enrolled will begin an up to 1-month HK Treatment Phase with SZC as per local label. Participants will receive dietary advice consistent with SoC at that site, including K+ restriction. A 4-month Diet Comparison Phase will begin next with participants being randomised to either continue taking SZC, which can be titrated as needed to maintain target S-K+ , and receive enhanced nutritional advice to consume fruit and vegetables (SZC arm), or SZC will be withdrawn and participants will receive SoC, including dietary K+ restriction (SoC arm).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Sodium Zirconium Cyclosilicate (SZC)

Intervention Type DRUG

Participants in the active arm will receive SZC dosed as per the local label to control hyperkalaemia and maintain normokalaemia.

Enhanced dietary advice

Intervention Type OTHER

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.

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.

Group Type OTHER

Standard dietary advice including K+ restriction.

Intervention Type OTHER

Participants randomised to the SoC arm of the Diet Comparison Phase will receive standard dietary advice including K+ restriction.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sodium Zirconium Cyclosilicate (SZC)

Participants in the active arm will receive SZC dosed as per the local label to control hyperkalaemia and maintain normokalaemia.

Intervention Type DRUG

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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SZC Standard dietary advice

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Participant must be ≥18 years of age at the time of signing the informed consent.
2. Participants with prevalent HK (S-K+ \>5.5 mmol/L at the end of LIDI) not requiring acute treatment.
3. Receiving haemodialysis 3 times a week with stable vascular access for at least 3 months before screening visit.
4. Participants who have and are able and willing to use smart phone (android or iOS) nutrition app.
5. 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.
6. 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.

Exclusion Criteria

1. 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.
2. 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.
3. Severe leucocytosis (\>20 × 109 /L) or thrombocytosis (≥450 × 109 /L) during screening.
4. Polycythaemia (haemoglobin \>14 g/dL) during screening.
5. Severe constipation, bowel obstruction, post-operative motility disorders.
6. Scheduled date for living donor kidney transplant.
7. Participants with a life expectancy of less than 6 months.
8. Females of childbearing potential, unless using contraception as detailed in the protocol or sexually abstinent.
9. Currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
10. Presence of cardiac arrhythmias or conduction defects that require immediate treatment at HCP discretion.
11. History of alcohol or drug abuse within 2 years prior to screening visit.
12. History of QT prolongation associated with other medications that required discontinuation of that medication.
13. Congenital long QT syndrome or QT interval corrected for heart rate (QTc) using Fridericia's method (QTcF) \>550 ms.
14. Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.
15. 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.
16. 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.
17. Participants with a known hypersensitivity or previous anaphylaxis to SZC or any of the excipients of the product.
18. Participants unable to take oral SZC. Prior/Concurrent Clinical Study Experience
19. Participation in another clinical study with an investigational product administered during the month before screening2 .
20. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
21. 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.
22. Previous enrolment in the present study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No