HyperkalemiaPhase 3NCT03172702
Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia
A Phase 3 study testing Zirconium Cyclosilicate in people with Hyperkalemia, run by AstraZeneca at 42 sites in Japan.
Trial summary
The Open-Label Maintenance Study contains an Correction Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a 12-month long-term Maintenance Phase. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Hyperkalemia
- What is being tested?
- Zirconium Cyclosilicate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 42 sitesJapan
- Study dates
- 4 Sep 2017to 6 Jul 2019
- 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 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-minutes (± 15 minutes) apart, both ≥ 5.1 mmol/L and measured within 1 day before the first dose of ZS on Correction Phase Study Day 1.
- Patients who are on peritoneal dialysis (PD) can be enrolled if their SK level is ≥5.5 and ≤ 6.5 mmol/L in two consecutive i-STAT potassium evaluation at least 24 hours apart before Day 1 (in each evaluation, two i-STAT potassium measurements at least 1 hour apart are required). i-STAT potassium measurement should be performed in the morning before breakfast and in the evening before dinner in PD patients on continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD), respectively.
- Women of childbearing potential must be using 2 forms of medically acceptable contraception (at least 1 barrier method) and have a negative pregnancy test within 1 day prior to the first dose of ZS on Correction Phase Study Day 1. Women who are surgically sterile or those who are postmenopausal for at least 1 year are not considered to be of childbearing potential.
Who cannot join
- Patients treated with lactulose, rifaxan (rifaximin), or other non-absorbed antibiotics for hyperammonemia within 7 days prior to first dose of ZS.
- 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. Washout of SPS and CPS for 7 days (or longer) prior to the first dose of ZS is allowed, if termination of CPS or SPS is judged to be clinically acceptable by the investigator. Documented informed consent has to be obtained prior to the washout.
- Patients with a life expectancy of less than 12 months
- Female patients who are pregnant, lactating, or planning to become pregnant
- Patients who have an active or history of diabetic ketoacidosis
- Known hypersensitivity or previous anaphylaxis to ZS or to components thereof
Show all 12Show fewer
- 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
- Hemodialysis patients (including those who are on both PD and hemodialysis [HD])
- Patients who have been on PD less than 6 months or more than 6 months with a history of hypokalemia within 6 months before Correction Phase Day 1
- Documented Glomerular Filtration Rate (GFR) < 15 mL/min within 90 days prior to study entry (Non peritoneal dialysis (PD) patients only)
- If patients joined ZS study in the past, the patients cannot join this study within the last 30 days of the last study drug administration day.
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
Japan42 sites
Research Site
Akashi-shi, 674-0063
Research Site
Amagasaki-shi, 660-8550
Research Site
Chiba, 260-8712
Research Site
Chiba, 263-0043
Research Site
Chiyoda-ku, 101-0047
Research Site
Chūōku, 104-0031
Research Site
Funabashi-shi, 273-8588
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
Kasuga-shi, 816-0864
Research Site
Kasugai-shi, 486-8510
Research Site
Kasugai-shi, 487-0016
Research Site
Kawachinagano-shi, 586-8521
Research Site
Kawasaki-shi, 216-8511
Research Site
Kitakyushu-shi, 802-0001
Research Site
Kochi, 780-0082
Research Site
Koga-shi, 306-0014
Research Site
Koga-shi, 306-0041
Research Site
Kumamoto, 861-8520
Research Site
Matsudo-shi, 271-0077
Research Site
Matsuyama, 791-8026
Research Site
Minokamo-shi, 505-8503
Research Site
Mito, 311-4153
Research Site
Nagoya, 457-8511
Research Site
Naka, 311-0113
Research Site
Omura-shi, 856-8562
Research Site
Onomichi-shi, 732-8503
Research Site
Osaka, 530-0001
Research Site
Osaka, 558-8558
Research Site
Osaka, 559-0012
Research Site
Shimajiri-gun, 901-0493
Research Site
Shizuoka, 421-0117
Research Site
Toride-shi, 302-0022
Research Site
Toshima-ku, 170-0003
Research Site
Toyohashi, 441-8570
Research Site
Yakushi, 581-0011
Research Site
Yotsukaido-shi, 284-0027
About this study
Official title: A Phase 3 Multicenter Open-label Maintenance Study to Investigate the Long-term Safety of ZS (Sodium Zirconium Cyclosilicate) in Japanese Subjects With Hyperkalemia
The Open-Label Maintenance Study contains an Correction Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a 12-month long-term Maintenance Phase.
Read the detailed description
The study will start with the screening period, and all baseline parameters should be measured/collected up to 1 day prior to administration of first dose of study drug on Correction Phase Day 1. Subjects with 2 consecutive i-STAT potassium values ≥ 5.1 mmol/L will enter the Correction Phase and receive ZS 10 g TID for up to 72 hours, depending on potassium values. Once normokalemia (i-STAT potassium between 3.5 and 5.0 mmol/L, inclusive) is restored (whether after 24, 48 or 72 hours), subjects will be entered into the Maintenance Phase to be dosed with ZS at a starting dose of 5 g QD. Potassium (i-STAT and Central Laboratory) will be measured Days 1, 2, 5, 12, 19 and 26 throughout the first month of study and every 4 weeks thereafter until Day 362 (Visit 23) then patients will be required to complete the EOS visit which is 7±1 days after the last administration of study medication. For patients who do not enter the Maintenance Phase the last visit will be 7±1 day after the last treatment dose in the Correction Phase. The total expected study duration for an individual patient is approximately 53-54 weeks.
- Conditions
- Hyperkalemia
- Being tested
- Zirconium Cyclosilicate
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconium CyclosilicateDrug
Also called ZS
Correction Phase Dosing: Sodium Zirconium Cyclosilicate 10 g three times daily (TID) from 24 to 72 Extended Dosing: Sodium Zirconium Cyclosilicate 5 g once daily (QD). Sodium Zirconium Cyclosilicate dose increased or decreased in increments/decrements of 5 g QD up to a maximum of 15 g QD or a minimum of 5 g every other day (QOD) (or 2.5 g QD) based on i-STAT potassium measurements up to 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Zirconium Cyclosilicate | Experimental | Correction Phase Dosing: Sodium Zirconium Cyclosilicate 10 g three times daily (TID) from 24 to 72 Extended Dosing: Sodium Zirconium Cyclosilicate 5 g once daily (QD). Sodium Zirconium Cyclosilicate dose increased or decreased in increments/decrements of 5 g QD up to a maximum of 15 g QD or a minimum of 5 g every other day (QOD) (or 2.5 g QD) based on i-STAT potassium measurements up to 12 months. Receives: Drug: Zirconium Cyclosilicate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Experienced Adverse Events (AEs) in the MP
The number of patients who experienced any AE, including those which were serious (SAE), had an outcome of death, were severe, led to discontinuation of ZS or were causally related to ZS are presented for the MP. AEs of special interest are also presented, including oedema-related AEs, cardiac failure and hypertension.
Measured: First MP dose up to 1 day (2 days for QOD regimen) after last MP dose.
Secondary outcomes (16)
Percentage of Patients Who Were Normokalemic in the MP
The percentage of patients who were normokalemic at each study visit in the MP is presented. Normokalemia was defined as a serum potassium (S-K) level of ≥ 3.5 and ≤ 5.0 mmol/L. The percentage of patients who were normokalemic at their last on-treatment visit is also presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days on QOD regimen) after the last ZS dose. End of Study was defined as the last ZS dose + 7 days.
Measured: MP Day 1 to End of Study visit (up to 12 months).
Percentage of Patients With Average S-K Levels of ≤5.1 mmol/L and ≤5.5 mmol/L in the MP
The percentage of patients who had an average S-K level of ≤5.1 mmol/L and ≤5.5 mmol/L over the MP up to Day 362 is presented.
Measured: MP Day 2 to Day 362.
Percentage of Patients Who Were Hypokalemic in the MP
The percentage of patients who were hypokalemic at each study visit in the MP is presented. Hypokalemia was defined as a S-K level of < 3.5 mmol/L. The percentage of patients who were hypokalemic at their last on-treatment visit is also presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days on QOD regimen) after the last ZS dose. End of Study was defined as the last ZS dose + 7 days.
Measured: MP Day 1 to End of Study visit (up to 12 months).
Percentage of Patients Who Were Hyperkalemic in the MP
The percentage of patients who were hyperkalemic at each study visit in the MP is presented. Hyperkalemia was defined as a S-K level of >5.0 mmol/L. The percentage of patients who were hyperkalemic at their last on-treatment visit is also presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days on QOD regimen) after the last ZS dose. End of Study was defined as the last ZS dose + 7 days.
Measured: MP Day 1 to End of Study visit (up to 12 months).
Mean Change From CP Baseline in the Mean S-K Level Over Specified Time Periods in the MP
The mean changes from the CP baseline in S-K level over specified periods of time in the MP are presented. Baseline for the CP was defined as the mean of 2 different S-K values, recorded 60 minutes apart (to confirm qualification for study entry) on the CP Day 1.
Measured: CP Day 1 to MP Day 362.
Mean Change From MP Baseline in the Mean S-K Level Over Specified Time Periods in the MP
The mean changes from the MP baseline in S-K level over specified periods of time in the MP are presented. Baseline for the MP was defined as the measurement taken in the morning of the day of entering the MP (MP Day 1).
Measured: MP Day 1 to Day 362.
Mean Number of Normokalemic Days During the MP
The number of normokalemic days during the MP was calculated assuming the time interval between assessments was normokalemic if both the beginning and end assessments for that time interval displayed normal S-K values. If an intermediate scheduled assessment time point was missing, then the scheduled assessment was regarded as not normokalemic. The mean number of normokalemic days for a patient in the MP is presented.
Measured: MP Day 1 to Day 362.
Mean Change in S-K Level From Last On-treatment MP Visit to the End of Study
The mean change in the S-K level from the last on-treatment MP visit to the End of Study is presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose. The End of Study was 7 days after the last ZS dose.
Measured: MP Day 1 to End of Study visit (up to 12 months).
Change From CP Baseline in S-Aldosterone Levels Over the MP
The mean change from CP baseline to MP Day 166 and MP Day 362 in S-aldosterone levels is presented. In addition, the mean change from CP baseline to the last on-treatment value is presented. The CP baseline was defined as the last S-aldosterone assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose.
Measured: CP Day 1, MP Day 166 and MP Day 362.
Percentage of Patients With Normal S-Aldosterone Levels Over the MP
The percentage of patients with normal S-aldosterone levels up to Day 362 of the MP is presented. The normal range for S-aldosterone was 0 - 776.72 pmol/L. In addition, the percentage of patients with normal S-aldosterone levels at the last on-treatment visit is presented. The CP baseline was defined as the last S-aldosterone assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose.
Measured: CP Day 1, MP Day 166 and MP Day 362.
Change From CP Baseline in S-Bicarbonate Levels Over the MP
The mean change from CP baseline to timepoints in the MP in S-bicarbonate levels is presented. In addition, the mean change from CP baseline to the last on-treatment value is presented. The CP baseline was defined as the last S-bicarbonate assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose. The End of Study was 7 days after the last ZS dose.
Measured: CP Day 1, and MP Day 1 to End of Study visit (up to 12 months).
Percentage of Patients With Normal S-Bicarbonate Levels Over the MP
The percentage of patients with normal S-bicarbonate levels up to the End of Study visit in the MP is presented. The normal range for S-bicarbonate was 17 - 32 mmol/L. In addition, the percentage of patients with normal S-bicarbonate levels at the last on-treatment visit is presented. The CP baseline was defined as the last S-bicarbonate assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose. The End of Study was 7 days after the last ZS dose.
Measured: CP Day 1 and MP Day 1 to End of Study visit (up to 12 months).
Baseline and Post-baseline 36-Item Short Form Health Survey Version 2 (SF-36 v2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
Patients completed the SF-36 v2 questionnaire on Day 1 of the CP and on Day 362 of the MP. The responses to the items assessing the physical and mental health of the patients determined the PCS and MCS based on a standard algorithm. The PCS and MCS scores ranged from 0 (worst possible health state) to 100 (best possible health state). The mean PCS and MCS are presented for the baseline and post-baseline assessments.
Measured: CP Day 1 (baseline) and MP Day 362 (post-baseline).
Mean Change From CP Baseline in the Mean S-K Levels in the CP
The mean change from the CP baseline at 24, 48 and 72 hours in the CP is presented. The mean change from baseline to the last on-treatment CP value is also presented. The last on-treatment value was defined as the last measurement taken with 1 day (2 days if on the QOD regimen) after the last ZS dose. Baseline for the CP was defined as the mean of 2 different S-K values, recorded 60 minutes apart (to confirm qualification for study entry) on the CP Day 1.
Measured: CP Day 1 to Day 3.
Percentage of Patients Who Were Normokalemic in the CP
The percentage of patients who were normokalemic at 24, 48 and 72 hours in the CP is presented. Normokalemia was defined as a S-K level of ≥ 3.5 and ≤ 5.0 mmol/L.
Measured: CP Day 1 to Day 3.
Number of Patients Who Experienced AEs in the CP
The number of patients who experienced any AE, including SAEs, those which had an outcome of death, were severe, led to discontinuation of ZS or were causally related to ZS are presented for the CP. AEs of special interest are also presented, including oedema-related AEs, cardiac failure and hypertension.
Measured: Day 1 of CP to last CP dose + 1 day or first MP dose -1 day, earlier.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start4 Sep 2017
- Primary completion6 Jul 2019
- Study completion6 Jul 2019
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 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172702
- Sponsor's protocol ID
- D9482C00001
- Status last verified
- Apr 2020
- First submitted
- 22 May 2017
- Last updated
- 1 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kashihara N, Yamasaki Y, Osonoi T, Harada H, Shibagaki Y, Zhao J, Kim H, Yajima T, Sarai N. A phase 3 multicenter open-label maintenance study to investigate the long-term safety of sodium zirconium cyclosilicate in Japanese subjects with hyperkalemia. Clin Exp Nephrol. 2021 Feb;25(2):140-149. doi: 10.1007/s10157-020-01972-y. Epub 2020 Oct 24.
PubMed 33098526
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multicenter Open-label Maintenance Study to Investigate the Long-term Safety of ZS (Sodium Zirconium Cyclosilicate) in Japanese Subjects With Hyperkalemia
- ClinicalTrials.gov ID
- NCT03172702
- Acronym / sponsor ID
- D9482C00001
- Conditions
- Hyperkalemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 6 Jul 2019 (actual)
- Study completion
- 6 Jul 2019 (actual)
- First posted
- 1 Jun 2017 (actual)
- Results
- Posted 1 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Open-Label Maintenance Study contains an Correction Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a 12-month long-term Maintenance Phase.
Detailed description
The study will start with the screening period, and all baseline parameters should be measured/collected up to 1 day prior to administration of first dose of study drug on Correction Phase Day 1. Subjects with 2 consecutive i-STAT potassium values ≥ 5.1 mmol/L will enter the Correction Phase and receive ZS 10 g TID for up to 72 hours, depending on potassium values. Once normokalemia (i-STAT potassium between 3.5 and 5.0 mmol/L, inclusive) is restored (whether after 24, 48 or 72 hours), subjects will be entered into the Maintenance Phase to be dosed with ZS at a starting dose of 5 g QD. Potassium (i-STAT and Central Laboratory) will be measured Days 1, 2, 5, 12, 19 and 26 throughout the first month of study and every 4 weeks thereafter until Day 362 (Visit 23) then patients will be required to complete the EOS visit which is 7±1 days after the last administration of study medication. For patients who do not enter the Maintenance Phase the last visit will be 7±1 day after the last treatment dose in the Correction Phase. The total expected study duration for an individual patient is approximately 53-54 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sodium Zirconium Cyclosilicate | Experimental | Drug: Zirconium CyclosilicateCorrection Phase Dosing: Sodium Zirconium Cyclosilicate 10 g three times daily (TID) from 24 to 72 Extended Dosing: Sodium Zirconium Cyclosilicate 5 g once daily (QD). Sodium Zirconium Cyclosilicate dose increased or decreased in increments/decrements of 5 g QD up to a maximum of 15 g QD or a minimum of 5 g every other day (QOD) (or 2.5 g QD) based on i-STAT potassium measurements up to 12 months. |
Who may qualify
- Ages
- 18 to 130 years
- 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-minutes (± 15 minutes) apart, both ≥ 5.1 mmol/L and measured within 1 day before the first dose of ZS on Correction Phase Study Day 1.
- Patients who are on peritoneal dialysis (PD) can be enrolled if their SK level is ≥5.5 and ≤ 6.5 mmol/L in two consecutive i-STAT potassium evaluation at least 24 hours apart before Day 1 (in each evaluation, two i-STAT potassium measurements at least 1 hour apart are required). i-STAT potassium measurement should be performed in the morning before breakfast and in the evening before dinner in PD patients on continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD), respectively.
- Women of childbearing potential must be using 2 forms of medically acceptable contraception (at least 1 barrier method) and have a negative pregnancy test within 1 day prior to the first dose of ZS on Correction Phase Study Day 1. Women who are surgically sterile or those who are postmenopausal for at least 1 year are not considered to be of childbearing potential.
Key exclusion criteria (12 listed)
- Patients treated with lactulose, rifaxan (rifaximin), or other non-absorbed antibiotics for hyperammonemia within 7 days prior to first dose of ZS.
- 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. Washout of SPS and CPS for 7 days (or longer) prior to the first dose of ZS is allowed, if termination of CPS or SPS is judged to be clinically acceptable by the investigator. Documented informed consent has to be obtained prior to the washout.
- Patients with a life expectancy of less than 12 months
- Female patients who are pregnant, lactating, or planning to become pregnant
- Patients who have an active or history of diabetic ketoacidosis
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 |
|---|---|---|
| Zirconium CyclosilicateAlso: ZSCorrection Phase Dosing: Sodium Zirconium Cyclosilicate 10 g three times daily (TID) from 24 to 72 Extended Dosing: Sodium Zirconium Cyclosilicate 5 g once daily (QD). Sodium Zirconium Cyclosilicate dose increased or decreased in increments/decrements of 5 g QD up to a maximum of 15 g QD or a minimum of 5 g every other day (QOD) (or 2.5 g QD) based on i-STAT potassium measurements up to 12 months. | Drug | Sodium Zirconium Cyclosilicate |
Primary outcome
Number of Patients Who Experienced Adverse Events (AEs) in the MP
Time frame: First MP dose up to 1 day (2 days for QOD regimen) after last MP dose.
The number of patients who experienced any AE, including those which were serious (SAE), had an outcome of death, were severe, led to discontinuation of ZS or were causally related to ZS are presented for the MP. AEs of special interest are also presented, including oedema-related AEs, cardiac failure and hypertension.
16 secondary outcomes
Percentage of Patients Who Were Normokalemic in the MP
Time frame: MP Day 1 to End of Study visit (up to 12 months).
Percentage of Patients With Average S-K Levels of ≤5.1 mmol/L and ≤5.5 mmol/L in the MP
Time frame: MP Day 2 to Day 362.
Percentage of Patients Who Were Hypokalemic in the MP
Time frame: MP Day 1 to End of Study visit (up to 12 months).
Percentage of Patients Who Were Hyperkalemic in the MP
Time frame: MP Day 1 to End of Study visit (up to 12 months).
Mean Change From CP Baseline in the Mean S-K Level Over Specified Time Periods in the MP
Time frame: CP Day 1 to MP Day 362.
Mean Change From MP Baseline in the Mean S-K Level Over Specified Time Periods in the MP
Time frame: MP Day 1 to Day 362.
Mean Number of Normokalemic Days During the MP
Time frame: MP Day 1 to Day 362.
Mean Change in S-K Level From Last On-treatment MP Visit to the End of Study
Time frame: MP Day 1 to End of Study visit (up to 12 months).
Change From CP Baseline in S-Aldosterone Levels Over the MP
Time frame: CP Day 1, MP Day 166 and MP Day 362.
Percentage of Patients With Normal S-Aldosterone Levels Over the MP
Time frame: CP Day 1, MP Day 166 and MP Day 362.
Change From CP Baseline in S-Bicarbonate Levels Over the MP
Time frame: CP Day 1, and MP Day 1 to End of Study visit (up to 12 months).
Percentage of Patients With Normal S-Bicarbonate Levels Over the MP
Time frame: CP Day 1 and MP Day 1 to End of Study visit (up to 12 months).
Baseline and Post-baseline 36-Item Short Form Health Survey Version 2 (SF-36 v2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
Time frame: CP Day 1 (baseline) and MP Day 362 (post-baseline).
Mean Change From CP Baseline in the Mean S-K Levels in the CP
Time frame: CP Day 1 to Day 3.
Percentage of Patients Who Were Normokalemic in the CP
Time frame: CP Day 1 to Day 3.
Number of Patients Who Experienced AEs in the CP
Time frame: Day 1 of CP to last CP dose + 1 day or first MP dose -1 day, earlier.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33098526Kashihara N, Yamasaki Y, Osonoi T, Harada H, Shibagaki Y, Zhao J, Kim H, Yajima T, Sarai N. A phase 3 multicenter open-label maintenance study to investigate the long-term safety of sodium zirconium cyclosilicate in Japanese subjects with hyperkalemia. Clin Exp Nephrol. 2021 Feb;25(2):140-149. doi: 10.1007/s10157-020-01972-y. Epub 2020 Oct 24.
- D9482C0000 redacted CSPLink provided by the sponsor.
- D9482C00001 redacted SAPLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
42 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 Zirconium Cyclosilicate in people with Hyperkalemia, run by AstraZeneca at 42 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 12 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 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 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. 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 1 May 2020). 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?
Number of Patients Who Experienced Adverse Events (AEs) in the MP (time frame: First MP dose up to 1 day (2 days for QOD regimen) after last MP dose.). 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 NCT03172702, 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 1 May 2020.