A Phase 4 interventional study of Sodium Zirconium Cyclosilicate (SZC) and Local standard of care in Hyperkalaemia and Chronic Kidney Disease, sponsored by AstraZeneca. Completed at 28 sites in 6 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment
This is an open-label, randomised study in participants with chronic kidney disease (CKD) treated for hyperkalaemia (HK) whilst in hospital. The study will compare SZC to standard of care (SoC) with the goal of determining:
This is a Phase 4, randomised, controlled, open-label, parallel-group, multicentre study in participants with CKD treated for HK whilst in hospital.
During the in-hospital phase, participants will be treated with SZC as per local label, starting at baseline and based on local K+ measurement obtained within 24 hours of treatment initiation:).
Participants with HK (K+ between > 5.0 and ≤ 6.5 mmol/L):
At discharge, NK participants who have been treated with SZC for between 1 and 21 days whilst in hospital and are started on SZC maintenance dose will be randomised in a 1:1 ratio to one of the following arms:
In-hospital phase: - The screening visit will occur while the participant is at the hospital (up to 21 days before discharge; medical monitor's approval may be sought for allowing longer duration hospital stays for specific participants) in order to check eligibility criteria
Inpatient phase: o The baseline visit (can occur the same day as the screening visit) where treatment with SZC will be initiated
o The discharge visit, 1 to 20 days after baseline; medical monitor's approval may be sought for allowing longer duration hospital stays for specific participants). Randomisation will occur at day of discharge.
Follow-up phase: - A follow-up on-site visit (end of study visit) will occur approximately 7 days after EOT. • Data will be collected at on-site visits, via telephone visits and medical chart reviews.
133 studies on the registry are indexed under Hyperkalemia; 25 are open to participants now.
This study's enrollment of 186 is above the median of 87 across 102 interventional studies indexed under Hyperkalemia.
Browse Hyperkalemia studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
With:
Note: Race/ethnicity should not be included in CKD-EPI equation calculation.
Exclusion Criteria:
Note: Initiation of any SZC or patiromer during the current ED visit/hospitalisation preceding enrolment is allowed.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants discharged with SZC, as per local label, to manage HK until the end of the outpatient phase
Drug: Sodium Zirconium Cyclosilicate (SZC)
Participants discharged with SoC, as per local practice, to manage HK until the end of study.
Drug: Local standard of care
White to grey crystalline powder for oral suspension in 5 g sachets. Each sachet will be labeled in accordance with Good Manufacturing Practice Annex 13 and per country regulatory requirement. Label text will be translated into local language.
Also known as: Lokelma
Local SoC in the country to be used as per local label
Also known as: SoC
Occurrence (Yes/No) of NK (K+ Between 3.5 and 5.0 mmol/L, Inclusive) at 180 Days Post-discharge
A response was defined as a participant having serum K+ within 3.5 and 5.0 mmol/L at 180 days post-discharge. No response was defined as a participant who: 1) used rescue therapy for hyperkalaemia (HK) during the outpatient period; 1) died prior to 180 days post-discharge; 3) were missing an assessment at visit 10; 4) were lost to follow-up prior to 180 days post-discharge; 5) down-titrated (or discontinued) RAASi. The number of participants who had a response/no response is presented.
Time frame: At 180 days post-discharge (Visit 10)
Time to First Occurrence of Any Component of All-cause Hospital Admissions or ED Visits With HK as a Contributing Factor, or All-cause Death, or Use of Rescue Therapy for HK at Any Time Post-discharge up to 180 Days
The time to first occurrence of all-cause hospital admission, emergency department (ED) visits with HK as a contributing factor, all-cause death or use of rescue therapy for HK was calculated as date of first occurrence of (all-cause hospital admission, ED visits with HK as a contributing factor, all-cause death, use of rescue therapy for HK, date of loss to follow-up) - date of randomization + 1. The median time to event (days) is presented.
Time frame: At any time post-discharge (from Visits 4 to 10), up to 180 days
Time to First Occurrence of Any Component of All-cause Hospital Admission or ED Visit With HK as a Contributing Factor at Any Time Post-discharge up to 180 Days
The time to first occurrence of any component of all-cause hospital admission or ED visit with HK as a contributing factor at any time post-discharge up to 180 days was calculated as the earliest date of (all-cause hospital admission, ED visits with HK as a contributing factor, all-cause death, use of rescue therapy for HK, date of loss to follow-up, date of 180 days post-discharge) - date of randomization + 1. The median time to event (days) is presented.
Time frame: At any time post-discharge (from Visits 4 to 10), up to 180 days
Number of All-cause Events (Hospital Admissions or ED Visits) With HK as a Contributing Factor at Any Time Post-discharge up to 180 Days
The number of all-cause events (hospital admissions or ED visits) with HK as a contributing factor at any time post-discharge up to 180 days is presented. Participants who discontinued treatment, used rescue therapy for HK, experienced all-cause death or loss to follow-up prior to 180 days post-discharge or who down-titrated (including discontinued) RAASi were to have all available hospital admission data used irrespective of the intercurrent event (treatment policy strategy).
Time frame: At any time post-discharge (from Visits 4 to 10), up to 180 days
Time to First Occurrence of RAASi Down-titration (or Discontinuation) at Any Time Post-discharge up to 180 Days
The time to first occurrence of RAASi down-titration (or discontinuation) was calculated as date of first occurrence of (RAASi down-titration, all-cause death, date of loss to follow-up) - date of randomization + 1. The median time to event (days) is presented.
Time frame: At any time post-discharge (from Visits 4 to 10), up to 180 days
Time to First Occurrence of Hospital Admission or ED Visit, Both With HK as a Contributing Factor at Any Time Post-discharge up to 180 Days
The time to first occurrence of hospital admission or ED visit, both with HK as a contributing factor, was calculated as date of first occurrence of (Hospital admission or ED visit with HK as a contributing factor, all-cause death, use of rescue therapy for HK, date of loss to follow-up) - date of randomization + 1. The median time to event (days) is presented.
Time frame: At any time post-discharge (from Visits 4 to 10), up to 180 days
Number of Events (Hospital Admissions or ED Visits) With HK as a Contributing Factor, at Any Time Post-discharge up to 180 Days
The number of events (hospital admissions or ED visits) with HK as a contributing factor, at any time post-discharge up to 180 days is presented. Participants who discontinued treatment, used rescue therapy for HK, experienced all-cause death or loss to follow-up prior to 180 days post-discharge or who downtitrated (including discontinued) RAASi were to have all available hospital admission data used irrespective of the intercurrent event (treatment policy strategy).
Time frame: At any time post-discharge (from Visits 4 to 10), up to 180 days
A total of 186 participants were screened from 28 study sites across 6 countries.
| Milestone | Inpatient Period | Outpatient Period - Arm A: SZC | Outpatient Period - Arm B: Standard of Care (SoC) |
|---|---|---|---|
| Started | 186 | 0 | 0 |
| Completed | 137 | 0 | 0 |
| Not completed | 49 | 0 | 0 |
| Withdrew: Participant was discharged from the hospital but did not inform the site | 1 | 0 | 0 |
| Withdrew: Withdrawal of consent | 10 | 0 | 0 |
| Withdrew: Failure to meet inclusion/exclusion criteria | 19 | 0 | 0 |
| Withdrew: Screening failure | 8 | 0 | 0 |
| Withdrew: Death | 2 | 0 | 0 |
| Withdrew: Physician decision | 5 | 0 | 0 |
| Withdrew: Adverse event | 3 | 0 | 0 |
| Withdrew: Withdrawn from study due to a mistaken request for study termination | 1 | 0 | 0 |
| Milestone | Inpatient Period | Outpatient Period - Arm A: SZC | Outpatient Period - Arm B: Standard of Care (SoC) |
|---|---|---|---|
| Started | 0 | 68 | 69 |
| Completed | 0 | 42 | 56 |
| Not completed | 0 | 26 | 13 |
| Withdrew: Adverse event | 0 | 9 | 0 |
| Withdrew: Death | 0 | 6 | 2 |
| Withdrew: Development of study-specific withdrawal criteria: severe hk | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
| Withdrew: Participant's study compliance was impossible to monitor and they had a complex private situation. | 0 | 1 | 0 |
| Withdrew: Scheduled hemodialysis | 0 | 1 | 0 |
| Withdrew: Severe hk | 0 | 0 | 1 |
| Withdrew: Started dialysis on 16 feb 2023 | 0 | 1 | 0 |
| Withdrew: Start of dialysis | 0 | 0 | 1 |
| Withdrew: The participant entered hemodialysis | 0 | 0 | 1 |
| Withdrew: The participant moved to another city and could not attend the study visits | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 8 | 5 |
A response was defined as a participant having serum K+ within 3.5 and 5.0 mmol/L at 180 days post-discharge. No response was defined as a participant who: 1) used rescue therapy for hyperkalaemia (HK) during the outpatient period; 1) died prior to 180 days post-discharge; 3) were missing an assessment at visit 10; 4) were lost to follow-up prior to 180 days post-discharge; 5) down-titrated (or discontinued) RAASi. The number of participants who had a response/no response is presented.
| Number of participants | Arm A: SZC | Arm B: SoC |
|---|---|---|
| Response | 21 | 25 |
| No response | 47 | 44 |
The time to first occurrence of all-cause hospital admission, emergency department (ED) visits with HK as a contributing factor, all-cause death or use of rescue therapy for HK was calculated as date of first occurrence of (all-cause hospital admission, ED visits with HK as a contributing factor, all-cause death, use of rescue therapy for HK, date of loss to follow-up) - date of randomization + 1. The median time to event (days) is presented.
| Days | Arm A: SZC | Arm B: SoC |
|---|---|---|
| Time to First Occurrence of Any Component of All-cause Hospital Admissions or ED Visits With HK as a Contributing Factor, or All-cause Death, or Use of Rescue Therapy for HK at Any Time Post-discharge up to 180 Days | 136 (60.00 to NA) | NA (63.00 to NA) |
The time to first occurrence of any component of all-cause hospital admission or ED visit with HK as a contributing factor at any time post-discharge up to 180 days was calculated as the earliest date of (all-cause hospital admission, ED visits with HK as a contributing factor, all-cause death, use of rescue therapy for HK, date of loss to follow-up, date of 180 days post-discharge) - date of randomization + 1. The median time to event (days) is presented.
| Days | Arm A: SZC | Arm B: SoC |
|---|---|---|
| Time to First Occurrence of Any Component of All-cause Hospital Admission or ED Visit With HK as a Contributing Factor at Any Time Post-discharge up to 180 Days | NA (116.00 to NA) | NA (123.00 to NA) |
The number of all-cause events (hospital admissions or ED visits) with HK as a contributing factor at any time post-discharge up to 180 days is presented. Participants who discontinued treatment, used rescue therapy for HK, experienced all-cause death or loss to follow-up prior to 180 days post-discharge or who down-titrated (including discontinued) RAASi were to have all available hospital admission data used irrespective of the intercurrent event (treatment policy strategy).
| Events | Arm A: SZC | Arm B: SoC |
|---|---|---|
| Number of All-cause Events (Hospital Admissions or ED Visits) With HK as a Contributing Factor at Any Time Post-discharge up to 180 Days | 0.7 ± 0.92 | 0.6 ± 0.83 |
The time to first occurrence of RAASi down-titration (or discontinuation) was calculated as date of first occurrence of (RAASi down-titration, all-cause death, date of loss to follow-up) - date of randomization + 1. The median time to event (days) is presented.
| Days | Arm A: SZC | Arm B: SoC |
|---|---|---|
| Time to First Occurrence of RAASi Down-titration (or Discontinuation) at Any Time Post-discharge up to 180 Days | NA (NA to NA) | NA (NA to NA) |
The time to first occurrence of hospital admission or ED visit, both with HK as a contributing factor, was calculated as date of first occurrence of (Hospital admission or ED visit with HK as a contributing factor, all-cause death, use of rescue therapy for HK, date of loss to follow-up) - date of randomization + 1. The median time to event (days) is presented.
| Days | Arm A: SZC | Arm B: SoC |
|---|---|---|
| Time to First Occurrence of Hospital Admission or ED Visit, Both With HK as a Contributing Factor at Any Time Post-discharge up to 180 Days | NA (NA to NA) | NA (NA to NA) |
The number of events (hospital admissions or ED visits) with HK as a contributing factor, at any time post-discharge up to 180 days is presented. Participants who discontinued treatment, used rescue therapy for HK, experienced all-cause death or loss to follow-up prior to 180 days post-discharge or who downtitrated (including discontinued) RAASi were to have all available hospital admission data used irrespective of the intercurrent event (treatment policy strategy).
| Events | Arm A: SZC | Arm B: SoC |
|---|---|---|
| Number of Events (Hospital Admissions or ED Visits) With HK as a Contributing Factor, at Any Time Post-discharge up to 180 Days | 0.1 ± 0.24 | 0.1 ± 0.26 |
Collected over Inpatient period (IP): included treatment-emergent adverse events (TEAEs; including serious adverse events [SAEs]) during the IP up to randomization. and adverse events (AEs) prior to first dose that worsened post-dose, up to 14 days Outpatient period (OP): Included TEAEs (including SAEs) during the OP up to 7 days after last dose, and AEs prior to first dose that worsened post-dose, up to approximately 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Inpatient Period | 2/174 (1.1%) | 10/174 (5.7%) | 0/174 (0%) |
| Outpatient Period - Arm A: SZC | 6/68 (8.8%) | 29/68 (42.6%) | 22/68 (32.4%) |
| Outpatient Period - Arm B: SoC | 2/68 (2.9%) | 21/68 (30.9%) | 30/68 (44.1%) |
| Event | Inpatient Period | Outpatient Period - Arm A: SZC | Outpatient Period - Arm B: SoC |
|---|---|---|---|
| PneumoniaInfections and infestations | 0/174 | 3/68 | 1/68 |
| Acute kidney injuryRenal and urinary disorders | 0/174 | 3/68 | 1/68 |
| Urinary tract infectionInfections and infestations | 0/174 | 2/68 | 1/68 |
| HyperkalaemiaMetabolism and nutrition disorders | 0/174 | 1/68 | 2/68 |
| Chronic kidney diseaseRenal and urinary disorders | 0/174 | 1/68 | 2/68 |
| Cardiac failureCardiac disorders | 1/174 | 2/68 | 2/68 |
| Acute pulmonary oedemaRespiratory, thoracic and mediastinal disorders | 0/174 | 2/68 | 0/68 |
| DiarrhoeaGastrointestinal disorders | 0/174 | 1/68 | 0/68 |
| EnterocolitisGastrointestinal disorders | 0/174 | 0/68 | 1/68 |
| Gastric perforationGastrointestinal disorders | 0/174 | 1/68 | 0/68 |
| Event | Inpatient Period | Outpatient Period - Arm A: SZC | Outpatient Period - Arm B: SoC |
|---|---|---|---|
| HyperkalaemiaMetabolism and nutrition disorders | 0/174 | 12/68 | 17/68 |
| AnaemiaBlood and lymphatic system disorders | 0/174 | 3/68 | 8/68 |
| Urinary tract infectionInfections and infestations | 0/174 | 1/68 | 6/68 |
| Renal impairmentRenal and urinary disorders | 0/174 | 5/68 | 4/68 |
| Metabolic acidosisMetabolism and nutrition disorders | 0/174 | 3/68 | 4/68 |
| Cardiac failureCardiac disorders | 0/174 | 4/68 | 2/68 |
Safety Set Randomized. Of the 137 participants randomised into the 2 arms (68 participants in Arm A: SZC and 69 participants in Arm B: SoC), there was one participant in Arm B: SoC who did not receive treatment during the outpatient period and was excluded from the safety analysis.
| Age, Continuous(Years) | Outpatient Period - Arm A: SZC | Outpatient Period - Arm B: SoC | Total |
|---|---|---|---|
| Mean | 72.8 ± 10.25 | 72.1 ± 10.99 | 72.5 ± 10.59 |
| Age, Customized(Participants) | Outpatient Period - Arm A: SZC | Outpatient Period - Arm B: SoC | Total |
|---|---|---|---|
| 18-64 years | 14 | 13 | 27 |
| 65-84 years | 45 | 47 | 92 |
| >=85 years | 9 | 8 | 17 |
| Sex: Female, Male(Participants) | Outpatient Period - Arm A: SZC | Outpatient Period - Arm B: SoC | Total |
|---|---|---|---|
| Female | 25 | 16 | 41 |
| Male | 43 | 52 | 95 |
| Race/Ethnicity, Customized(Participants) | Outpatient Period - Arm A: SZC | Outpatient Period - Arm B: SoC | Total |
|---|---|---|---|
| Hispanic or Latino | 21 | 10 | 31 |
| Not Hispanic or Latino | 43 | 56 | 99 |
| Not Reported | 4 | 2 | 6 |
| Race/Ethnicity, Customized(Participants) | Outpatient Period - Arm A: SZC | Outpatient Period - Arm B: SoC | Total |
|---|---|---|---|
| White | 64 | 64 | 128 |
| Black or African American | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| American Indian or Alaskan Native | 0 | 0 | 0 |
| Other | 0 | 0 | 0 |
| Multiple | 0 | 0 | 0 |
| Not Reported | 4 | 3 | 7 |
| Country(Participants) | Outpatient Period - Arm A: SZC | Outpatient Period - Arm B: SoC | Total |
|---|---|---|---|
| Belgium | 0 | 2 | 2 |
| Spain | 57 | 59 | 116 |
| France | 4 | 2 | 6 |
| United Kingdom | 0 | 2 | 2 |
| Italy | 6 | 3 | 9 |
| Netherlands | 1 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Sodium zirconium cyclosilicate