HyperkalaemiaPhase 4GRAZENCT04997161
Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia
A Phase 4 study testing Sodium Zirconium Cyclosilicate (SZC), Enhanced dietary advice and Standard dietary advice including K+ restriction. in people with Hyperkalaemia, run by AstraZeneca at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Hyperkalaemia
- What is being tested?
- Sodium Zirconium Cyclosilicate (SZC), Enhanced dietary advice and Standard dietary advice including K+ restriction.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2021to 17 Nov 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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.
Read the detailed description
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
- Hyperkalaemia
- Being tested
- Sodium Zirconium Cyclosilicate (SZC), Enhanced dietary advice, Standard dietary advice including K+ restriction.
- Keywords
- Hyperkalaemia, Dialysis Patients
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Zirconium Cyclosilicate (SZC)Drug
Also called SZC
Participants in the active arm will receive SZC dosed as per the local label to control hyperkalaemia and maintain normokalaemia.
Enhanced dietary adviceOther
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.
Standard dietary advice including K+ restriction.Other
Also called Standard dietary advice
Participants randomised to the SoC arm of the Diet Comparison Phase will receive standard dietary advice including K+ restriction.
| Study group | Role | What they receive |
|---|---|---|
| SZC arm with enhanced dietary advice | Experimental | 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. Receives: Drug: Sodium Zirconium Cyclosilicate (SZC); Other: Enhanced dietary advice |
| SoC arm with standard dietary advice | Other | 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. Receives: Other: Standard dietary advice including K+ restriction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Potassium
Change in serum potassium taken at long interdialytic-dialysis interval visits Month 3, Month 4, and Month 5 compared to baseline
Measured: Baseline to Month 5
Secondary outcomes (4)
Change From Baseline in Fruit and Vegetable Consumption Determined by Participant-reported Intake Using Noom App From Month 2 to Month 5
Change from baseline in fruit and vegetable consumption determined by participant-reported intake using Noom app from Month 2 to Month 5
Measured: Month 2 to Month 5
Effect of the Combination of Sodium Zirconium Cyclosilicate and Enhanced Nutritional Advice as Compared to Standard of Care on Participant-reported Chronic Kidney Disease Symptoms, Physical and Mental Health, and Satisfaction With Treatment
Electronic versions of the following:
Kidney Disease and Quality of Life-36 item (KDQOL-36; symptoms/problems, Physical Component Summary and Mental Component Summary, Burden of Kidney Disease and Effects of Kidney Disease)
EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Abbreviated Treatment Satisfaction Questionnaire for Medication (9 items) (TSQM-9)
Patients' Global Impression of Change (PGIC)
Measured: From study start to study end
Effect of the Combination of Sodium Zirconium Cyclosilicate and Enhanced Nutritional Advice to Consume Fruit and Vegetables as Compared to Standard of Care in Maintaining Serum Potassium Levels
Effect of the combination of sodium zirconium cyclosilicate and enhanced nutritional advice to consume fruit and vegetables as compared to standard of care in maintaining serum potassium levels within a range of 3.5 to 5.5 mmol/L, without requiring rescue therapy for hyperkalaemia.
Binary response (responder/non-responder) with criteria that at least 66% of serum potassium values taken at long interdialytic-dialysis interval visits in Months 3, 4, and 5 fall between 3.5 and 5.5 mmol/L.
Receiving rescue therapy or a potassium binder for hyperkalaemia during the final 3 months of the study was to result in a non-response.
Measured: From study start to study end
Safety and Tolerability of Sodium Zirconium Cyclosilicate and Enhanced Nutritional Advice as Compared to Standard of Care
Safety and tolerability were to be evaluated in terms of adverse events (AEs), vital signs, clinical laboratory, interdialytic weight gain, and electrocardiograms.
Assessments related to AEs covered occurrence/frequency, relationship to sodium zirconium cyclosilicate as assessed by Investigator, intensity, seriousness, death, and AEs leading to discontinuation of sodium zirconium cyclosilicate.
Measured: From study start to study end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start17 Aug 2021
- Primary completion17 Nov 2021
- Study completion17 Nov 2021
Why it stopped: There is disconnect between dietary guidelines to limit potassium intake in dialysis and clinical practice. The number of unknowns and differences make the results unlikely to be translatable into clinical practice and will not benefit patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperkalaemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Wittbrodt, PharmD, MPH, Study director, AstraZeneca, Biopharmaceuticals Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997161
- Sponsor's protocol ID
- D9480C00014
- Other IDs
- 2021-000457-81
- Acronym
- GRAZE
- Status last verified
- Dec 2022
- First submitted
- 16 Jun 2021
- Last updated
- 19 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT04997161
- Acronym / sponsor ID
- GRAZE / D9480C00014
- Conditions
- Hyperkalaemia
- Keywords
- Hyperkalaemia, Dialysis Patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There is disconnect between dietary guidelines to limit potassium intake in dialysis and clinical practice. The number of unknowns and differences make the results unlikely to be translatable into clinical practice and will not benefit patients.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 17 Nov 2021 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Posted 19 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| SZC arm with enhanced dietary advice | Experimental | Drug: Sodium Zirconium Cyclosilicate (SZC), Other: Enhanced dietary adviceParticipants 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. |
| SoC arm with standard dietary advice | Other | Other: Standard dietary advice including K+ restriction.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. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Zirconium Cyclosilicate (SZC)Also: SZCParticipants in the active arm will receive SZC dosed as per the local label to control hyperkalaemia and maintain normokalaemia. | Drug | SZC arm with enhanced dietary advice |
| Enhanced dietary adviceParticipants 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 | SZC arm with enhanced dietary advice |
| Standard dietary advice including K+ restriction.Also: Standard dietary adviceParticipants randomised to the SoC arm of the Diet Comparison Phase will receive standard dietary advice including K+ restriction. | Other | SoC arm with standard dietary advice |
Primary outcome
Change in Serum Potassium
Time frame: Baseline to Month 5
Change in serum potassium taken at long interdialytic-dialysis interval visits Month 3, Month 4, and Month 5 compared to baseline
4 secondary outcomes
Change From Baseline in Fruit and Vegetable Consumption Determined by Participant-reported Intake Using Noom App From Month 2 to Month 5
Time frame: Month 2 to Month 5
Effect of the Combination of Sodium Zirconium Cyclosilicate and Enhanced Nutritional Advice as Compared to Standard of Care on Participant-reported Chronic Kidney Disease Symptoms, Physical and Mental Health, and Satisfaction With Treatment
Time frame: From study start to study end
Effect of the Combination of Sodium Zirconium Cyclosilicate and Enhanced Nutritional Advice to Consume Fruit and Vegetables as Compared to Standard of Care in Maintaining Serum Potassium Levels
Time frame: From study start to study end
Safety and Tolerability of Sodium Zirconium Cyclosilicate and Enhanced Nutritional Advice as Compared to Standard of Care
Time frame: From study start to study end
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical Study Protocol-redactedLink provided by the sponsor.
- Statistical Analysis Plan-redactedLink provided by the sponsor.
- CSR synopsis-redactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Wittbrodt, PharmD, MPH study director
AstraZeneca, Biopharmaceuticals Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Zirconium Cyclosilicate (SZC), Enhanced dietary advice and Standard dietary advice including K+ restriction. in people with Hyperkalaemia, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Potassium (time frame: Baseline to Month 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.