HyperkalemiaPhase 2/3NCT03127644
ZS Ph2/3 Dose-response Study in Japan
A Phase 2/3 study testing Sodium Zirconium Cyclosilicate (ZS) 5g and Sodium Zirconium Cyclosilicate (ZS) 10g in people with Hyperkalemia, run by AstraZeneca at 25 sites in Japan.
Trial summary
To assess efficacy of 5 g three times daily (TID) and 10 g TID ZS versus placebo in Japanese patients with hyperkalemia (serum potassium [S-K] ≥ 5.1 mmol/L and ≤ 6.5 mmol/L). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperkalemia
- What is being tested?
- Sodium Zirconium Cyclosilicate (ZS) 5g and Sodium Zirconium Cyclosilicate (ZS) 10g
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 25 sitesJapan
- Study dates
- 14 Jun 2017to 23 Feb 2018
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures.
- Patients aged ≥18. For patients aged <20 years, a written informed consent should be obtained from the patient and his or her legally acceptable representative.
- Two consecutive i-STAT potassium values, measured 60 (± 10) minutes apart, both values should be ≥ 5.1 mmol/L and ≤ 6.5 mmol/L and measured within 1 day before the first dose of study drug on Study Day 1.
- Ability to have repeated blood draws or effective venous catheterization.
- Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of ZS/matching placebo to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.
Who cannot join
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Cause or symptoms of pseudohyperkalemia, such as
- hemolyzed blood specimen due to excessive fist clenching to make veins prominent
- hemolyzed blood specimen due to difficult or traumatic venepuncture
- history of severe leukocytosis or thrombocytosis
- Patients treated with lactulose, rifaximin, or other non-absorbed antibiotics for hyperammonemia within 7 days prior to first dose of study drug on Study Day 1
Show all 16Show fewer
- Patients treated with resins (such as sevelamer hydrochloride, sodium polystyrene sulfonate [SPS; e.g. Kayexalate®] or calcium polystyrene sulfonate [CPS]), calcium acetate, calcium carbonate, or lanthanum carbonate, within 7 days prior to the first dose of study drug
- Patients with a life expectancy of less than 3 months
- Patients who are severely physically or mentally incapacitated and who, in the opinion of investigator, are unable to perform the patients' tasks associated with the protocol
- Female patients who are pregnant, lactating, or planning to become pregnant
- Patients who have an active or history of diabetic ketoacidosis
- Presence of any condition which, in the opinion of the investigator, places the patient at undue risk or potentially jeopardizes the quality of the data to be generated
- Known hypersensitivity or previous anaphylaxis to ZS or to components thereof
- Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry
- Patients with cardiac arrhythmias that require immediate treatment
- Patients on dialysis
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Japan25 sites
Research Site
Chiba, 260-8712
Research Site
Chiba, 263-0043
Research Site
Hanyu-shi, 348-8505
Research Site
Higashiibaraki-gun, 311-3193
Research Site
Hitachi-Naka, 312-0057
Research Site
Ina-shi, 396-8555
Research Site
Kagoshima, 892-8580
Research Site
Kahoku-gun, 920-0293
Research Site
Kamakura-shi, 247-8533
Research Site
Kanazawa, 920-8650
Research Site
Kasugai-shi, 486-8510
Research Site
Kawachinagano-shi, 586-8521
Research Site
Kawasaki-shi, 216-8511
Research Site
Kitakyushu-shi, 802-0001
Research Site
Koga-shi, 306-0041
Research Site
Kusatsu-shi, 525-8585
Research Site
Matsudo-shi, 271-0077
Research Site
Matsuyama, 791-8026
Research Site
Nagoya, 457-8511
Research Site
Naka, 311-0113
Research Site
Omura-shi, 856-8562
Research Site
Shimajiri-gun, 901-0493
Research Site
Shizuoka, 421-0117
Research Site
Yakushi, 581-0011
Research Site
Yotsukaido-shi, 284-0027
About this study
Official title: A Phase 2/3 Multicenter, Dose-response Study to Assess Efficacy and Safety of ZS (Sodium Zirconium Cyclosilicate), in Japanese Patients With Hyperkalemia
To assess efficacy of 5 g three times daily (TID) and 10 g TID ZS versus placebo in Japanese patients with hyperkalemia (serum potassium [S-K] ≥ 5.1 mmol/L and ≤ 6.5 mmol/L).
Read the detailed description
Patients not receiving any therapy for hyperkalemia and with 2 consecutive i-STAT potassium values of ≥ 5.1 mmol/L and ≤ 6.5 mmol/L will be enrolled and randomized 1:1:1 to receive ZS 5 g, ZS 10 g, or placebo TID for 48 hours.
Throughout the study most potassium values will be measured at fasting before taking study drug. Nothing should be taken by mouth except water, coffee or tea, with or without milk and/or sugar, and essential medications, prior to the blood collection for a minimum of 8 hours. Potassium level should be determined by both i-STAT and the Central Laboratory on all occasions. Treatment decisions (eg, stopping rules) will be made based on i-STAT potassium values, as these provide clinical sites with a real-time measurement. Statistical analyses on the study data will in principle be based on S-K values as measured by the central laboratory.
Safety and tolerability will be assessed on an ongoing basis. Standard study assessments including blood potassium, clinical chemistry (including calcium, magnesium, sodium, phosphate, creatinine, bicarbonate, and blood urea nitrogen [BUN]) and hematology parameters, urinalysis, vital signs, physical examinations, and electrocardiograms (ECGs) will be assessed during the study at the time points specified in the assessments schedule. All women of childbearing potential will have a urine pregnancy test prior to enrollment and at their End of Study (EOS) visit.
Stopping rules will be implemented to ensure subjects discontinue the study treatment and receive alternative therapy in case of significant hyperkalemia, hypokalemia, or significant cardiac arrhythmias.
- Conditions
- Hyperkalemia
- Being tested
- Sodium Zirconium Cyclosilicate (ZS) 5g, Sodium Zirconium Cyclosilicate (ZS) 10g, 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 Cyclosilicate (ZS) 5gDrug
Suspension administered 5g orally three times daily for 48 hours.
Sodium Zirconium Cyclosilicate (ZS) 10gDrug
Suspension administered 10g orally three times daily for 48 hours.
PlaceboDrug
Placebo suspension administered orally placebo three times daily for 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Zirconium Cyclosilicate (ZS) 5g | Experimental | Suspension administered 5g orally three times daily for 48 hours. Receives: Drug: Sodium Zirconium Cyclosilicate (ZS) 5g |
| Sodium Zirconium Cyclosilicate (ZS) 10g | Experimental | Suspension administered 10g orally three times daily for 48 hours. Receives: Drug: Sodium Zirconium Cyclosilicate (ZS) 10g |
| Placebo | Placebo comparator | Placebo suspension administered orally placebo three times daily for 48 hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exponential Rate of Change in Serum Potassium (S-K) Values During the Initial 48 Hours of Study Drug Treatment
Blood samples for determination of potassium were collected pre-dose, and at 1, 2, and 4 hours post Dose 1 on Day 1. An additional sample was collected at 90 minutes post Dose 2 on Day 1 if i-STAT potassium values at the 4-hour post Dose 1 time point was ≥ 6.1 or <4.0 mmol/L. On Day 2 samples were analysed pre-dose, and 1 and 4 hours post Dose 1. S-K levels were analysed at the Central Laboratory.
Natural logarithm of S-K from 0 to 48 hours post dose are modelled by the random coefficients model including fixed effects of intercept, time, time x treatment and patient-level random effects for time and intercept. Exponential rate of change refers to the slope estimate from the random coefficients model.
Measured: From 0 to 48 hours.
Secondary outcomes (8)
Percentage of Patients Who Achieved Normokalaemia at 48 Hours
The percentage of patients who achieved normokalaemia (normalisation of S-K values to between 3.5 mmol/L and 5.0 mmol/L, inclusive) at 48 hours after start of dosing was determined. Patients with missing S-K values at 48 hours were regarded as not normokalaemic.
Measured: At 48 hours.
Exponential Rate of Change in S-K Values During the Initial 24 Hours of Study Drug Treatment
Blood samples for determination of potassium were collected pre-dose, and at 1, 2, and 4 hours post Dose 1 on Day 1. An additional sample was collected at 90 minutes post Dose 2 on Day 1 if i-STAT potassium values at the 4-hour post Dose 1 time point was ≥ 6.1 or <4.0 mmol/L. On Day 2 samples were analysed pre-dose, and 1 and 4 hours post Dose 1. S-K levels were analysed at the Central Laboratory. Natural logarithm of S-K from 0 to 24 hours post dose are modelled by the random coefficients model including fixed effects of intercept, time, time x treatment and patient-level random effects for time and intercept. Exponential rate of change refers to the slope estimate from the random coefficients model.
Measured: From 0 to 24 hours.
Percentage of Patients Who Achieved Normokalaemia at 24 Hours
The percentage of patients who achieved normokalaemia (normalisation of S-K values to between 3.5 mmol/L and 5.0 mmol/L, inclusive) at 24 hours after start of dosing was determined. Patients with missing S-K values at 24 hours were regarded as not normokalaemic.
Measured: At 24 hours.
Percentage of Patients Who Achieved Normokalaemia at Each Scheduled Potassium Assessment Time Point
The percentage of patients who achieved normokalaemia (normalisation of S-K values to between 3.5 mmol/L and 5.0 mmol/L, inclusive) at each each scheduled potassium assessment time point after the start of dosing was determined. Patients with missing S-K values were regarded as not normokalaemic.
Measured: From baseline to end of study (9 days).
Mean Change From Baseline in S-K Values at All Measured Time Intervals
Blood samples for determination of potassium were collected pre-dose, and at 1, 2, and 4 hours post Dose 1 on Day 1. An additional sample was collected at 90 minutes post Dose 2 on Day 1 if i-STAT potassium values at the 4-hour post Dose 1 time point was ≥ 6.1 or <4.0 mmol/L. On Day 2 samples were analysed pre-dose, and 1 and 4 hours post Dose 1. S-K levels were analysed locally using i-STAT devices, and at the Central Laboratory. S-K values measured at each time point and end of study visit were recorded and mean change from baseline is displayed.
Measured: From baseline to end of study (9 days).
Mean Percent Change From Baseline in S-K Values at All Measured Time Intervals
Blood samples for determination of potassium were collected pre-dose, and at 1, 2, and 4 hours post Dose 1 on Day 1. An additional sample was collected at 90 minutes post Dose 2 on Day 1 if i-STAT potassium values at the 4-hour post Dose 1 time point was ≥ 6.1 or <4.0 mmol/L. On Day 2 samples were analysed pre-dose, and 1 and 4 hours post Dose 1. S-K levels were analysed locally using i-STAT devices, and at the Central Laboratory. S-K values measured at each time point and end of study visit were recorded and mean percent change from baseline is displayed.
Measured: From baseline to end of study (9 days).
Time to Normalisation in S-K Values
The distribution of time to normalisation of S-K values (defined as S-K values between 3.5 mmol/L and 5.0 mmol/L, inclusive) was measured. A patient who reached at least one S-K within normal range was counted as an event regardless of S-K value after that time point. Patients who did not achieve normokalaemia within 48 hours were censored.
Measured: From 0 to 48 hours.
Time to a Decrease in S-K Levels of 0.5 mmol/L
The median time (hours) for S-K values to decrease by 0.5 mmol/L was measured.
Measured: From 0 to 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start14 Jun 2017
- Primary completion23 Feb 2018
- Study completion23 Feb 2018
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 (1)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127644
- Sponsor's protocol ID
- D9482C00002
- Status last verified
- Feb 2019
- First submitted
- 5 Apr 2017
- Last updated
- 20 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kashihara N, Nishio T, Osonoi T, Saka Y, Imasawa T, Ohtake T, Mizuno H, Shibagaki Y, Kim H, Yajima T, Sarai N. Correction of serum potassium with sodium zirconium cyclosilicate in Japanese patients with hyperkalemia: a randomized, dose-response, phase 2/3 study. Clin Exp Nephrol. 2020 Dec;24(12):1144-1153. doi: 10.1007/s10157-020-01937-1. Epub 2020 Aug 10.
PubMed 32779057
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3 Multicenter, Dose-response Study to Assess Efficacy and Safety of ZS (Sodium Zirconium Cyclosilicate), in Japanese Patients With Hyperkalemia
- ClinicalTrials.gov ID
- NCT03127644
- Acronym / sponsor ID
- D9482C00002
- Conditions
- Hyperkalemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 23 Feb 2018 (actual)
- Study completion
- 23 Feb 2018 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Posted 20 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess efficacy of 5 g three times daily (TID) and 10 g TID ZS versus placebo in Japanese patients with hyperkalemia (serum potassium [S-K] ≥ 5.1 mmol/L and ≤ 6.5 mmol/L).
Detailed description
Patients not receiving any therapy for hyperkalemia and with 2 consecutive i-STAT potassium values of ≥ 5.1 mmol/L and ≤ 6.5 mmol/L will be enrolled and randomized 1:1:1 to receive ZS 5 g, ZS 10 g, or placebo TID for 48 hours.
Throughout the study most potassium values will be measured at fasting before taking study drug. Nothing should be taken by mouth except water, coffee or tea, with or without milk and/or sugar, and essential medications, prior to the blood collection for a minimum of 8 hours. Potassium level should be determined by both i-STAT and the Central Laboratory on all occasions. Treatment decisions (eg, stopping rules) will be made based on i-STAT potassium values, as these provide clinical sites with a real-time measurement. Statistical analyses on the study data will in principle be based on S-K values as measured by the central laboratory.
Safety and tolerability will be assessed on an ongoing basis. Standard study assessments including blood potassium, clinical chemistry (including calcium, magnesium, sodium, phosphate, creatinine, bicarbonate, and blood urea nitrogen [BUN]) and hematology parameters, urinalysis, vital signs, physical examinations, and electrocardiograms (ECGs) will be assessed during the study at the time points specified in the assessments schedule. All women of childbearing potential will have a urine pregnancy test prior to enrollment and at their End of Study (EOS) visit.
Stopping rules will be implemented to ensure subjects discontinue the study treatment and receive alternative therapy in case of significant hyperkalemia, hypokalemia, or significant cardiac arrhythmias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sodium Zirconium Cyclosilicate (ZS) 5g | Experimental | Drug: Sodium Zirconium Cyclosilicate (ZS) 5gSuspension administered 5g orally three times daily for 48 hours. |
| Sodium Zirconium Cyclosilicate (ZS) 10g | Experimental | Drug: Sodium Zirconium Cyclosilicate (ZS) 10gSuspension administered 10g orally three times daily for 48 hours. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo suspension administered orally placebo three times daily for 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of informed consent prior to any study specific procedures.
- Patients aged ≥18. For patients aged <20 years, a written informed consent should be obtained from the patient and his or her legally acceptable representative.
- Two consecutive i-STAT potassium values, measured 60 (± 10) minutes apart, both values should be ≥ 5.1 mmol/L and ≤ 6.5 mmol/L and measured within 1 day before the first dose of study drug on Study Day 1.
- Ability to have repeated blood draws or effective venous catheterization.
- Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of ZS/matching placebo to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.
Key exclusion criteria (16 listed)
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Cause or symptoms of pseudohyperkalemia, such as
- Patients treated with lactulose, rifaximin, or other non-absorbed antibiotics for hyperammonemia within 7 days prior to first dose of study drug on Study Day 1
- Patients treated with resins (such as sevelamer hydrochloride, sodium polystyrene sulfonate [SPS; e.g. Kayexalate®] or calcium polystyrene sulfonate [CPS]), calcium acetate, calcium carbonate, or lanthanum carbonate, within 7 days prior to the first dose of study drug
- Patients with a life expectancy of less than 3 months
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 (ZS) 5gSuspension administered 5g orally three times daily for 48 hours. | Drug | Sodium Zirconium Cyclosilicate (ZS) 5g |
| Sodium Zirconium Cyclosilicate (ZS) 10gSuspension administered 10g orally three times daily for 48 hours. | Drug | Sodium Zirconium Cyclosilicate (ZS) 10g |
| PlaceboPlacebo suspension administered orally placebo three times daily for 48 hours. | Drug | Placebo |
Primary outcome
Exponential Rate of Change in Serum Potassium (S-K) Values During the Initial 48 Hours of Study Drug Treatment
Time frame: From 0 to 48 hours.
Blood samples for determination of potassium were collected pre-dose, and at 1, 2, and 4 hours post Dose 1 on Day 1. An additional sample was collected at 90 minutes post Dose 2 on Day 1 if i-STAT potassium values at the 4-hour post Dose 1 time point was ≥ 6.1 or <4.0 mmol/L. On Day 2 samples were analysed pre-dose, and 1 and 4 hours post Dose 1. S-K levels were analysed at the Central Laboratory. Natural logarithm of S-K from 0 to 48 hours post dose are modelled by the random coefficients model including fixed effects of intercept, time, time x treatment and patient-level random effects for time and intercept. Exponential rate of change refers to the slope estimate from the random coefficients model.
8 secondary outcomes
Percentage of Patients Who Achieved Normokalaemia at 48 Hours
Time frame: At 48 hours.
Exponential Rate of Change in S-K Values During the Initial 24 Hours of Study Drug Treatment
Time frame: From 0 to 24 hours.
Percentage of Patients Who Achieved Normokalaemia at 24 Hours
Time frame: At 24 hours.
Percentage of Patients Who Achieved Normokalaemia at Each Scheduled Potassium Assessment Time Point
Time frame: From baseline to end of study (9 days).
Mean Change From Baseline in S-K Values at All Measured Time Intervals
Time frame: From baseline to end of study (9 days).
Mean Percent Change From Baseline in S-K Values at All Measured Time Intervals
Time frame: From baseline to end of study (9 days).
Time to Normalisation in S-K Values
Time frame: From 0 to 48 hours.
Time to a Decrease in S-K Levels of 0.5 mmol/L
Time frame: From 0 to 48 hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32779057Kashihara N, Nishio T, Osonoi T, Saka Y, Imasawa T, Ohtake T, Mizuno H, Shibagaki Y, Kim H, Yajima T, Sarai N. Correction of serum potassium with sodium zirconium cyclosilicate in Japanese patients with hyperkalemia: a randomized, dose-response, phase 2/3 study. Clin Exp Nephrol. 2020 Dec;24(12):1144-1153. doi: 10.1007/s10157-020-01937-1. Epub 2020 Aug 10.
Related trials for Hyperkalemia
Enrolling by invitationObservational study
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
RecruitingPhase 3
A Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
Hyperkalemia
Not yet recruiting
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
Enrolling by invitationPhase 4
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
Chronic Kidney Disease, Type 2 Diabetes
Recruiting
Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study
Hyperkalemia, Chronic Kidney Disease (Stages 4 and 5)
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.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sodium Zirconium Cyclosilicate (ZS) 5g and Sodium Zirconium Cyclosilicate (ZS) 10g in people with Hyperkalemia, run by AstraZeneca at 25 sites in Japan.
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 5 inclusion and 16 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 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Japan. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 20 May 2019). 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?
Exponential Rate of Change in Serum Potassium (S-K) Values During the Initial 48 Hours of Study Drug Treatment (time frame: From 0 to 48 hours.). 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 NCT03127644, which also lists 1 linked publication.
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 20 May 2019.