HyperkalemiaPhase 3DIALIZE ChinaNCT04217590
Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects
A Phase 3 study testing Sodium Zirconium Cyclosilicate in people with Hyperkalemia, run by AstraZeneca at 36 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Sodium Zirconium Cyclosilicate (SZC), as well as the appropriateness of the dosing mechanism, in Chinese end-stage renal disease (ESRD) patients on chronic haemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Hyperkalemia
- What is being tested?
- Sodium Zirconium Cyclosilicate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 36 sitesChina
- Study dates
- 16 Nov 2020to 3 Jan 2022
- Phase
- Phase 3
- 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
- Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.
- Subject must be ≥ 18 years of age inclusive, at the time of signing the informed consent form.
- Subjects must have haemodialysis access consisting of an arteriovenous fistula, AV graft, or tunnelled (permanent) catheter which is expected to remain in place for the entire duration of the study.
- Receiving haemodialysis (or hemodiafiltration) 3 times a week for treatment of end-stage renal disease (ESRD) for at least 3 months before randomization.
- Pre-dialysis S-K > 5.4 mmol/L after long inter-dialytic interval and > 5.0 mmol/L after at least one short inter-dialytic interval during screening (as assessed by central lab).
- Prescribed dialysate K concentration ≤ 3 mmol/L during screening.
- Sustained Qb ≥ 200 ml/min and spKt/V ≥ 1.2 (or URR ≥ 63) on stable haemodialysis / haemodiafltration prescription during screening with prescription (time, dialyzer, blood flow [Qb], dialysate flow rate [Qd] and bicarbonate concentration) expected to remain unchanged during study.
- Subjects must be receiving dietary counselling appropriate for ESRD subjects treated with haemodialysis / haemodiafiltration as per local guidelines, which includes dietary potassium restriction.
Who cannot join
- Myocardial infarction, acute coronary syndrome, stroke, seizure or a thrombotic / thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism, but excluding vascular access thrombosis) within 12 weeks prior to randomization.
- Pseudohyperkalaemia secondary to haemolyzed blood specimen (this situation is not considered screening failure, sampling or full screening can be postponed to a later time as applicable).
- Diagnosis of rhabdomyolysis during the 4 weeks preceding randomization.
- Presence of cardiac arrhythmias or conduction defects that require immediate treatment.
- Any medical condition, including active, clinically significant infection or liver disease, that in the opinion of the investigator or Sponsor may pose a safety risk to a subject in this study, which may confound safety or efficacy assessment and jeopardize the quality of the data, or may interfere with study participation.
- History of QT prolongation associated with other medications that required discontinuation of that medication; congenital long QT syndrome or QTc(f) > 550 msec; uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication or with transient atrial fibrillation associated with dialysis or peridialytic period are permitted.
Show all 23Show fewer
- Subjects treated with sodium polystyrene sulfonate (e.g. SPS, Kayexalate, Resonium), calcium polystyrene sulfonate (CPS, Resonium calcium) or patiromer (Veltassa) within 7 days before screening or anticipated in requiring any of these agents during the study.
- Participation in another clinical study with an investigational product administered in the last 1 month before screening.
- Haemoglobin < 9 g/dL on screening (as assessed on Visit 1).
- Laboratory diagnosis of hypokalaemia (K < 3.5 mmol/L), hypocalcemia (Ca < 8.2 mg/d or albumin-corrected Ca < 8.0 mg/dL if the latter is used in local practice), hypomagnesemia (Mg < 1.7 mg/dL) or severe acidosis (serum bicarbonate 16 mEq/L or less) in the 4 weeks preceding randomization.
- Severe leukocytosis (> 20 × 109/L) or thrombocytosis (≥ 450 × 109/L) during screening.
- Polycythaemia (Hb > 14 g/dL) during screening.
- 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 subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.
- Previous randomisation in the present study.
- For women only - currently pregnant (confirmed with positive pregnancy test or uterine ultrasound if pregnancy test is questionable) or breast-feeding.
- Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence.
- Lack of compliance with haemodialysis prescription (both number and duration of treatments) during the two-week period preceding screening (100% compliance required).
- Subjects unable to take investigational product drug mix.
- Scheduled date for living donor kidney transplant.
- Subjects with a life expectancy of less than 6 months.
- Known hypersensitivity or previous anaphylaxis to SZC or to components thereof.
- History of alcohol or drug abuse within 2 years prior to randomization.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
China36 sites
Research Site
Baotou, 014040
Research Site
Baotou, 14010
Research Site
Beijing, 100029
Research Site
Beijing, 100044
Research Site
Beijing, 100191
Research Site
Beijing, 102206
Research Site
Changchun, 130021
Research Site
Changchun, 130041
Research Site
Dongguan, 523009
Research Site
Hangzhou, 310014
Research Site
Hefei, 230001
Research Site
Hohhot, 010017
Research Site
Jinan, 250014
Research Site
Lanzhou, 730000
Research Site
Lanzhou, 730030
Research Site
Nanchang, 330006
Research Site
Nanjing, 210011
Research Site
Ningbo, 315000
Research Site
Ningbo, 315010
Research Site
Shanghai, 200065
Research Site
Shanghai, 200080
Research Site
Shanghai, 200090
Research Site
Shanghai, 200120
Research Site
Shanghai, 200127
Research Site
Shanghai, 200232
Research Site
Shanghai, 200233
Research Site
Shanghai, 200240
Research Site
Shanghai, 201199
Research Site
Shenzhen, 518035
Research Site
Shenzhen, 518053
Research Site
Tianjin, 300052
Research Site
Ürümqi, CN-830004
Research Site
Wenzhou, 325000
Research Site
Wenzhou, 325027
Research Site
Yangzhou, 225001
Research Site
Yinchuan, 750004
About this study
Official title: A Phase 3b, Multicentre, Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects
The purpose of this study is to evaluate the efficacy and safety of Sodium Zirconium Cyclosilicate (SZC), as well as the appropriateness of the dosing mechanism, in Chinese end-stage renal disease (ESRD) patients on chronic haemodialysis.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study to determine the safety and efficacy of SZC in ESRD subjects with hyperkalaemia and on stable haemodialysis. This study consists of a screening period, an 8-week randomized treatment period, and a follow-up period. Approximately 134 stable haemodialysis subjects with persistent pre-dialysis hyperkalaemia will be enrolled in the study across research sites in China.
- Conditions
- Hyperkalemia
- Being tested
- Sodium Zirconium Cyclosilicate, Placebo
- 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 CyclosilicateDrug
Also called SZC; Lokelma; ZS
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) Single dose contains from 1 to 3 sachets of SZC 5g depending on dose level assigned to a patient per non-dialysis days.
PlaceboDrug
Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) Single dose contains from 1 to 3 sachets of Placebo depending on dose level assigned to a patient per non-dialysis days.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Zirconium Cyclosilicate (SZC) | Experimental | Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) Single dose contains from 1 to 3 sachets of SZC 5g depending on dose level assigned to a patient per non-dialysis days. Receives: Drug: Sodium Zirconium Cyclosilicate |
| Placebo | Placebo comparator | Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) Single dose contains from 1 to 3 sachets of Placebo depending on dose level assigned to a patient per non-dialysis days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Responders
A subject was considered to be a responder if, during the evaluation period, they maintained a pre-dialysis serum potassium (S-K) between 4.0 and 5.0 mmol/L on at least 3 out of 4 dialysis treatments following the long inter-dialytic interval (LIDI) and did not receive rescue therapy. Subjects with no data during the evaluation period were classified as non-responders. The S-K levels used for this analysis were based on the measurements obtained by the central laboratory.
Measured: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.
Secondary outcomes (5)
Maximum Pre-dialysis S-K Values After SIDI and LIDI Below or Equal to 5.5 mmol/L During Evaluation Period
Probability of maintaining maximum S-K value <= 5.5 mmol/L was evaluated. Each subject's maximum pre-dialysis S-K at long inter-dialytic interval (LIDI) and short inter-dialytic interval (SIDI) visits during the evaluation period were categorised into <= 5.5 or > 5.5 mmol/L. Missing S-K values including those omitted due to coinciding with rescue therapy use or records omitted that are not true LIDI (i.e. records which do not occur >= 55 hours after the previous dialysis starting time) were imputed using multiple imputation (MI).
Measured: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.
Pre-dialysis S-K After LIDI Between 3.5 and 5.5 mmol/L During the Evaluation Period
Probability of all S-K values between 3.5 and 5.5 mmol/L was evaluated. Subjects were categorised to either having all pre-dialysis LIDI values between 3.5 and 5.5 mmol/L during the evaluation period or not. Missing S-K values including those omitted due to coinciding with rescue therapy use or records omitted that are not true LIDI (i.e. records which do not occur >= 55 hours after the previous dialysis starting time) were imputed using multiple imputation (MI).
Measured: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.
Instances of Pre-dialysis S-K After LIDI Between 4.0 and 5.0 mmol/L During the Evaluation Period
The probability of maintaining instances of pre-dialysis S-K between 4.0 and 5.0 mmol/L (normokalaemia) was evaluated at each LIDI visit during the evaluation period, by categorisation of pre-dialysis S-K into values between 4.0 and 5.0 mmol/L or not. Values coinciding with rescue therapy or not true LIDI (i.e. records which do not occur >= 55 hours after the previous dialysis starting time) were excluded.
Measured: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.
Expected Number of Normokalaemic (S-K 4.0-5.0 mmol/L) Instances
The expected number of normokalemic instances is the sum of the probabilities of normokalaemic instance at each visit during the evaluation period. Normokalaemic is defined as S-K between 4.0 and 5.0 mmol/L.
Measured: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.
Instances of Potassium Gradient of < 3.0 mmol/L After LIDI During the Evaluation Period
The probability of maintaining instances of potassium gradient of < 3.0 mmol/L was evaluated at each LIDI visit during the evaluation period, by categorisation of potassium gradient into < 3.0 or >=3.0 mmol/L. Values coinciding with rescue therapy or not true LIDI (i.e. records which do not occur >= 55 hours after the previous dialysis starting time) were excluded.
Measured: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start16 Nov 2020
- Primary completion3 Jan 2022
- Study completion3 Jan 2022
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperkalemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhaohui Ni, Principal investigator, Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217590
- Sponsor's protocol ID
- D9485C00001
- Acronym
- DIALIZE China
- Status last verified
- Feb 2023
- First submitted
- 2 Jan 2020
- Last updated
- 28 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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.
Publications
Ni Z, Lu R, Xu X, Bian X, Zhou Z, Yang J, Luo Q, Chen M, Chen C, Sun X, Yu L, He Q, Jiang H, Yuan W, Li Y, Zhou R, Wang J, Zhang X, Zuo L, Meng X, Chang Z, Zhao J, Wessman P, Xiang P; DIALIZE China Study Group. DIALIZE China: A Phase IIIb, Randomized, Placebo-Controlled Study to Reduce Predialysis Hyperkalemia With Sodium Zirconium Cyclosilicate in Chinese Patients. Clin Ther. 2023 Jul;45(7):633-642. doi: 10.1016/j.clinthera.2023.04.014. Epub 2023 Jun 27.
PubMed 37385905Natale P, Palmer SC, Ruospo M, Saglimbene VM, Strippoli GF. Potassium binders for chronic hyperkalaemia in people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Jun 26;6(6):CD013165. doi: 10.1002/14651858.CD013165.pub2.
PubMed 32588430
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Multicentre, Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects
- ClinicalTrials.gov ID
- NCT04217590
- Acronym / sponsor ID
- DIALIZE China / D9485C00001
- Conditions
- Hyperkalemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 3 Jan 2022 (actual)
- First posted
- 3 Jan 2020 (actual)
- Results
- Posted 28 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of Sodium Zirconium Cyclosilicate (SZC), as well as the appropriateness of the dosing mechanism, in Chinese end-stage renal disease (ESRD) patients on chronic haemodialysis.
Detailed description
This is a randomized, double-blind, placebo-controlled study to determine the safety and efficacy of SZC in ESRD subjects with hyperkalaemia and on stable haemodialysis. This study consists of a screening period, an 8-week randomized treatment period, and a follow-up period. Approximately 134 stable haemodialysis subjects with persistent pre-dialysis hyperkalaemia will be enrolled in the study across research sites in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Zirconium Cyclosilicate (SZC) | Experimental | Drug: Sodium Zirconium CyclosilicateSuspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) Single dose contains from 1 to 3 sachets of SZC 5g depending on dose level assigned to a patient per non-dialysis days. |
| Placebo | Placebo comparator | Drug: PlaceboSuspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) Single dose contains from 1 to 3 sachets of Placebo depending on dose level assigned to a patient per non-dialysis days. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.
- Subject must be ≥ 18 years of age inclusive, at the time of signing the informed consent form.
- Subjects must have haemodialysis access consisting of an arteriovenous fistula, AV graft, or tunnelled (permanent) catheter which is expected to remain in place for the entire duration of the study.
- Receiving haemodialysis (or hemodiafiltration) 3 times a week for treatment of end-stage renal disease (ESRD) for at least 3 months before randomization.
- Pre-dialysis S-K > 5.4 mmol/L after long inter-dialytic interval and > 5.0 mmol/L after at least one short inter-dialytic interval during screening (as assessed by central lab).
Key exclusion criteria (23 listed)
- Myocardial infarction, acute coronary syndrome, stroke, seizure or a thrombotic / thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism, but excluding vascular access thrombosis) within 12 weeks prior to randomization.
- Pseudohyperkalaemia secondary to haemolyzed blood specimen (this situation is not considered screening failure, sampling or full screening can be postponed to a later time as applicable).
- Diagnosis of rhabdomyolysis during the 4 weeks preceding randomization.
- Presence of cardiac arrhythmias or conduction defects that require immediate treatment.
- Any medical condition, including active, clinically significant infection or liver disease, that in the opinion of the investigator or Sponsor may pose a safety risk to a subject in this study, which may confound safety or efficacy assessment and jeopardize the quality of the data, or may interfere with study participation.
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 CyclosilicateAlso: SZC; Lokelma; ZSSuspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) Single dose contains from 1 to 3 sachets of SZC 5g depending on dose level assigned to a patient per non-dialysis days. | Drug | Sodium Zirconium Cyclosilicate (SZC) |
| PlaceboSuspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) Single dose contains from 1 to 3 sachets of Placebo depending on dose level assigned to a patient per non-dialysis days. | Drug | Placebo |
Primary outcome
Percentage of Responders
Time frame: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.
A subject was considered to be a responder if, during the evaluation period, they maintained a pre-dialysis serum potassium (S-K) between 4.0 and 5.0 mmol/L on at least 3 out of 4 dialysis treatments following the long inter-dialytic interval (LIDI) and did not receive rescue therapy. Subjects with no data during the evaluation period were classified as non-responders. The S-K levels used for this analysis were based on the measurements obtained by the central laboratory.
5 secondary outcomes
Maximum Pre-dialysis S-K Values After SIDI and LIDI Below or Equal to 5.5 mmol/L During Evaluation Period
Time frame: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.
Pre-dialysis S-K After LIDI Between 3.5 and 5.5 mmol/L During the Evaluation Period
Time frame: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.
Instances of Pre-dialysis S-K After LIDI Between 4.0 and 5.0 mmol/L During the Evaluation Period
Time frame: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.
Expected Number of Normokalaemic (S-K 4.0-5.0 mmol/L) Instances
Time frame: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.
Instances of Potassium Gradient of < 3.0 mmol/L After LIDI During the Evaluation Period
Time frame: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37385905Ni Z, Lu R, Xu X, Bian X, Zhou Z, Yang J, Luo Q, Chen M, Chen C, Sun X, Yu L, He Q, Jiang H, Yuan W, Li Y, Zhou R, Wang J, Zhang X, Zuo L, Meng X, Chang Z, Zhao J, Wessman P, Xiang P; DIALIZE China Study Group. DIALIZE China: A Phase IIIb, Randomized, Placebo-Controlled Study to Reduce Predialysis Hyperkalemia With Sodium Zirconium Cyclosilicate in Chinese Patients. Clin Ther. 2023 Jul;45(7):633-642. doi: 10.1016/j.clinthera.2023.04.014. Epub 2023 Jun 27.
- Derived from this study: PubMed 32588430Natale P, Palmer SC, Ruospo M, Saglimbene VM, Strippoli GF. Potassium binders for chronic hyperkalaemia in people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Jun 26;6(6):CD013165. doi: 10.1002/14651858.CD013165.pub2.
- CSP RedactedLink provided by the sponsor.
- Statistical Analysis PlanLink provided by the sponsor.
- CSR SynopsisLink 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.
Zhaohui Ni principal investigator
Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, China.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium Zirconium Cyclosilicate in people with Hyperkalemia, run by AstraZeneca at 36 sites in China.
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 23 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: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 28 Mar 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?
Percentage of Responders (time frame: Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04217590, which also lists 2 linked publications.
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 28 Mar 2023.