A Phase 4 interventional study of Sodium zirconium cyclosilicate and Placebo in Hyperkalaemia and Heart Failure With Reduced Ejection Fraction, sponsored by AstraZeneca. Completed at 89 sites in 8 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment
The main objective of this study is to evaluate the efficacy of SZC as compared with placebo in keeping potassium levels within the normal range (3.5-5.0 mEq/L) while on spironolactone ≥25 mg daily without assistance of rescue therapy for hyperkalaemia (HK).
REALIZE-K is a Phase 4, multinational, multicenter, double-blind, placebo-controlled, randomized-withdrawal, parallel-group study that includes the following 3 phases: screening, 4-6 week open-label run-in phase where sodium zirconium cyclosilicate (SZC) and spironolactone will be optimized, followed by a 6-month double-blind, placebo-controlled, randomized withdrawal treatment phase.
Patients meeting the following criteria will enter the 4-6 week open-label run-in phase: symptomatic heart failure with reduced ejection fraction (HFrEF); receiving an angiotensin-converting enzyme inhibitor (ACEi), angiotensin II receptor blocker (ARB), or angiotensin receptor-Neprilysin inhibitor (ARNi); receiving no spironolactone or eplerenone, or receiving low-dose spironolactone (\<25 mg daily); receiving a beta-blocker unless contraindicated; AND with hyperkalemia (sK+ 5.1-5.9 mEq/L) and an eGFR >/= 30 mL/min/1.73m2, OR normokalemic (sK+ 3.5-5.0 mEq/L) and 'at risk' of developing hyperkalemia (ie, history of hyperkalemia within the past 36 months and eGFR >/= 30 mL/min/1.73m2, or sK+ 4.5-5.0 mEq/L and eGFR 30-60 mL/min/1.73m2 and/or age >75 years).
Patients who are normokalemic on SZC and receiving spironolactone >/= 25 mg daily at the end of the open-label run-in phase will enter the 6-month double-blind, placebo-controlled, randomized withdrawal treatment phase. Eligible patients will be randomized 1:1, stratified by run-in phase sK+ cohort.
133 studies on the registry are indexed under Hyperkalemia; 25 are open to participants now.
This study's enrollment of 366 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.
EXCLUSION CRITERIA
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.
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 New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cohort 1 (4 weeks duration): Patients who are hyperkalemic at study entry will begin SZC 10 g TID for up to 48 hours followed by SZC 10 g once daily to achieve and maintain normokalemia. The SZC dose will be adjusted as needed to maintain normokalemia (dose range = 5 g every other day, to 5-15 g once daily). Cohort 2 (up to 6 weeks duration): Patients who develop hyperkalemia during the uptitration of spironolactone will receive SZC 10 g TID for up to 48 hours followed by SZC 10 g once daily to achieve and maintain normokalemia. The SZC dose will be adjusted as needed to maintain normokalemia (dose range = 5 g every other day, to 5-15 g once daily).
Drug: Sodium zirconium cyclosilicate · Drug: Placebo · Other: Spironolactone
SZC arm and Placebo arm: Patients will continue on the SZC dose they were receiving at the end of the run-in phase. The SZC / Placebo dose will be adjusted as needed to maintain normokalemia (dose range = 5 g every other day, to 5-15 g once daily).
Drug: Sodium zirconium cyclosilicate · Drug: Placebo · Other: Spironolactone
Investigational medicinal product
Also known as: SZC
Placebo comparator
Background intervention. During the run-in phase, spironolactone will be initiated/uptitrated up to a maximum of 50 mg per day. During the randomized withdrawal phase the spironolactone dose at the end of the run-in phase will be maintained.
Participants Who Achieved Response, Defined as Serum Potassium (sK+) Within 3.5 to 5.0 mEq/L, Spironolactone Greater Than or Equal to 25 mg Daily, no Rescue Therapy for Hyperkalaemia
The median percentages of participants having a response are presented. Response means all three requirements were met. Non-response was indicated for participants lost to follow-up, including death. The treatment effect was analysed using a generalised estimating equation (GEE) model with a binomial family and a log link, a dependent variable of response per visit, fixed independent variables of randomised treatment, subject recruitment country, a per visit indicator variable and open-label period cohort. The common odds ratio was derived together with two-sided 95% confidence intervals.
Time frame: From Month 1 (Visit 9) to Month 6 (Visit 14), up to 6 months
Participants Who Achieved Response, Defined as sK+ Within 3.5-5.0 mEq/L, on the Same Dose of Spironolactone as Randomisation, no Rescue Therapy for Hyperkalaemia
The median percentages of participants who achieved a response are presented. Response means all three requirements were met. Non-response was indicated for participants lost to follow-up, including death. The analysis was performed using a GEE model with a binomial family and a log link, a dependent variable of response per visit, fixed independent variables of randomised treatment, subject recruitment country, a per visit indicator variable and open-label period cohort. The common odds ratio was derived together with two-sided 95% confidence intervals.
Time frame: From Month 1 (Visit 9) to Month 6 (Visit 14), up to 6 months
Participants Who Achieved Response, Defined as Spironolactone Greater Than or Equal to 25 mg Daily
The median percentages of participants who achieved a response are presented. Response means that the requirement was met. Non-response was indicated for subjects lost to follow-up, including death. The analysis was performed using a GEE model with a binomial family and a log link, a dependent variable of response per visit, fixed independent variables of randomised treatment, subject recruitment country, a per visit indicator variable and open-label period cohort. The common odds ratio was derived together with two-sided 95% confidence intervals.
Time frame: From Month 1 (Visit 9) to Month 6 (Visit 14), up to 6 months
Time to First Hyperkalaemia (sK+ Greater Than 5.0mEq/L) Episode
The time to first hyperkalaemia episode for participants on SZC compared to placebo during the randomised-withdrawal period, with hyperkalaemia defined as sK+ greater than 5.0 mEq/L as assessed by central laboratory, is presented in median time (days). The analysis was performed using a Cox regression model including randomised treatment group and subject recruitment country, adjusted for the stratification factor (hyperkalaemia vs normokalaemia at study entry). Placebo group used as reference level in Cox model.
Time frame: From randomisation to the end of treatment (EOT) visit, up to 6 months
Time to First Instance of Decrease or Discontinuation of Spironolactone Dose Due to Hyperkalaemia
The time to first instance of decrease or discontinuation of spironolactone dose due to hyperkalaemia is presented in median time (days). The analysis was performed using a Cox regression model, adjusted for the stratification factor (hyperkalaemia vs normokalaemia at study entry).
Time frame: From randomisation to the EOT visit, up to 6 months
Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) at EOT
The KCCQ is a 23-item instrument measuring, from the patients' perspectives, their heart failure-related symptoms, physical and social limitations, self-efficacy, and health-related quality of life (QoL) over the prior 2 weeks. It was scored as follows: Physical Limitation (items 1a-f), Symptom Stability (item 2), Symptom Frequency (items 3, 5, 7, and 9), Symptom Burden (items 4, 6, and 8), Self Efficacy (items 10 and 11), QoL (items 12, 13, and 14), and Social Limitation (items 15a-d). Scores were calculated by summing the responses within each domain and by taking the average. Scale scores were transformed to a 0 to 100 range, with 0 implying the lowest level of functioning and 100 for the highest level of functioning. The CSS was calculated as the average of Physical Limitation Score and Total Symptom Score (TSS) and the TSS was calculated as the average of Symptom Frequency and Symptom Burden Scores. The change from randomisation in KCCQ-CSS is reported.
Time frame: At EOT visit (approximately 6 months post-randomisation)
Location and Severity of Peripheral Oedema
The location and severity of peripheral oedema that occurred during the randomised-withdrawal phase are presented. Participants with multiple peripheral oedema events were counted only once. The location of oedema is not mutually exclusive so multiple locations may apply for each participant.
Time frame: During the randomised-withdrawal period and up to 14 days after discontinuation of SZC or placebo, up to 6.5 months
| Milestone | Open-label Run-in Phase | Randomized-withdrawal Phase - SZC Group | Randomized-withdrawal Phase - Placebo Group |
|---|---|---|---|
| Started | 366 | 0 | 0 |
| Completed | 203 | 0 | 0 |
| Not completed | 163 | 0 | 0 |
| Withdrew: Adverse event | 3 | 0 | 0 |
| Withdrew: Death | 3 | 0 | 0 |
| Withdrew: Study-specific withdrawal criteria | 2 | 0 | 0 |
| Withdrew: Failure to meet randomization criteria | 144 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 8 | 0 | 0 |
| Withdrew: Withdrawn from study due to withdrawal by co-investigator | 1 | 0 | 0 |
| Withdrew: Withdrawn from study due to withdrawal by pi | 1 | 0 | 0 |
| Milestone | Open-label Run-in Phase | Randomized-withdrawal Phase - SZC Group | Randomized-withdrawal Phase - Placebo Group |
|---|---|---|---|
| Started | 0 | 102 | 101 |
| Completed | 0 | 88 | 87 |
| Not completed | 0 | 14 | 14 |
| Withdrew: Adverse event | 0 | 5 | 5 |
| Withdrew: Death | 0 | 1 | 2 |
| Withdrew: Development of study-specific withdrawal criteria | 0 | 2 | 4 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
| Withdrew: Withdrawn from study due to pd - wrong doses of spironolactone | 0 | 1 | 0 |
| Withdrew: Withdrawn from study due to spironolactone was stopped on may 28, related hyperkalaemia | 0 | 1 | 0 |
| Withdrew: Withdrawn from study due to the participant did not have enough medication by issues in iwrs | 0 | 0 | 1 |
| Withdrew: Withdrawn from study due to the patient was random by mistake on this date he was an olrif | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 2 | 2 |
The median percentages of participants having a response are presented. Response means all three requirements were met. Non-response was indicated for participants lost to follow-up, including death. The treatment effect was analysed using a generalised estimating equation (GEE) model with a binomial family and a log link, a dependent variable of response per visit, fixed independent variables of randomised treatment, subject recruitment country, a per visit indicator variable and open-label period cohort. The common odds ratio was derived together with two-sided 95% confidence intervals.
| Percentage of participants | Randomized-withdrawal Phase - SZC Group | Randomized-withdrawal Phase - Placebo Group |
|---|---|---|
| Participants Who Achieved Response, Defined as Serum Potassium (sK+) Within 3.5 to 5.0 mEq/L, Spironolactone Greater Than or Equal to 25 mg Daily, no Rescue Therapy for Hyperkalaemia | 72.1 | 35.7 |
The median percentages of participants who achieved a response are presented. Response means all three requirements were met. Non-response was indicated for participants lost to follow-up, including death. The analysis was performed using a GEE model with a binomial family and a log link, a dependent variable of response per visit, fixed independent variables of randomised treatment, subject recruitment country, a per visit indicator variable and open-label period cohort. The common odds ratio was derived together with two-sided 95% confidence intervals.
| Percentage of participants | Randomized-withdrawal Phase - SZC Group | Randomized-withdrawal Phase - Placebo Group |
|---|---|---|
| Participants Who Achieved Response, Defined as sK+ Within 3.5-5.0 mEq/L, on the Same Dose of Spironolactone as Randomisation, no Rescue Therapy for Hyperkalaemia | 58.2 | 22.9 |
The median percentages of participants who achieved a response are presented. Response means that the requirement was met. Non-response was indicated for subjects lost to follow-up, including death. The analysis was performed using a GEE model with a binomial family and a log link, a dependent variable of response per visit, fixed independent variables of randomised treatment, subject recruitment country, a per visit indicator variable and open-label period cohort. The common odds ratio was derived together with two-sided 95% confidence intervals.
| Percentage of participants | Randomized-withdrawal Phase - SZC Group | Randomized-withdrawal Phase - Placebo Group |
|---|---|---|
| Participants Who Achieved Response, Defined as Spironolactone Greater Than or Equal to 25 mg Daily | 81.4 | 49.5 |
The time to first hyperkalaemia episode for participants on SZC compared to placebo during the randomised-withdrawal period, with hyperkalaemia defined as sK+ greater than 5.0 mEq/L as assessed by central laboratory, is presented in median time (days). The analysis was performed using a Cox regression model including randomised treatment group and subject recruitment country, adjusted for the stratification factor (hyperkalaemia vs normokalaemia at study entry). Placebo group used as reference level in Cox model.
| Days | Randomized-withdrawal Phase - SZC Group | Randomized-withdrawal Phase - Placebo Group |
|---|---|---|
| Time to First Hyperkalaemia (sK+ Greater Than 5.0mEq/L) Episode | 65.0 (35.00 to 98.00) | 9.0 (8.00 to 13.00) |
The time to first instance of decrease or discontinuation of spironolactone dose due to hyperkalaemia is presented in median time (days). The analysis was performed using a Cox regression model, adjusted for the stratification factor (hyperkalaemia vs normokalaemia at study entry).
| Days | Randomized-withdrawal Phase - SZC Group | Randomized-withdrawal Phase - Placebo Group |
|---|---|---|
| Time to First Instance of Decrease or Discontinuation of Spironolactone Dose Due to Hyperkalaemia | NA (NA to NA) | NA (NA to NA) |
The KCCQ is a 23-item instrument measuring, from the patients' perspectives, their heart failure-related symptoms, physical and social limitations, self-efficacy, and health-related quality of life (QoL) over the prior 2 weeks. It was scored as follows: Physical Limitation (items 1a-f), Symptom Stability (item 2), Symptom Frequency (items 3, 5, 7, and 9), Symptom Burden (items 4, 6, and 8), Self Efficacy (items 10 and 11), QoL (items 12, 13, and 14), and Social Limitation (items 15a-d). Scores were calculated by summing the responses within each domain and by taking the average. Scale scores were transformed to a 0 to 100 range, with 0 implying the lowest level of functioning and 100 for the highest level of functioning. The CSS was calculated as the average of Physical Limitation Score and Total Symptom Score (TSS) and the TSS was calculated as the average of Symptom Frequency and Symptom Burden Scores. The change from randomisation in KCCQ-CSS is reported.
| Score on a scale | Randomized-withdrawal Phase - SZC Group | Randomized-withdrawal Phase - Placebo Group |
|---|---|---|
| Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) at EOT | 71.27 ± 2.57 | 72.27 ± 2.36 |
The location and severity of peripheral oedema that occurred during the randomised-withdrawal phase are presented. Participants with multiple peripheral oedema events were counted only once. The location of oedema is not mutually exclusive so multiple locations may apply for each participant.
| Participants | Randomized-withdrawal Phase - SZC Group | Randomized-withdrawal Phase - Placebo Group |
|---|---|---|
| Location of oedema: pedal oedema | 13 | 10 |
| Location of oedema: ankle oedema | 17 | 13 |
| Location of oedema: pretibial oedema | 11 | 5 |
| Location of oedema: thigh oedema | 1 | 0 |
| Severity of pedal oedema - right side: trace | 4 | 3 |
| Severity of pedal oedema - right side: mild | 1 | 5 |
| Severity of pedal oedema - right side: moderate | 7 | 1 |
| Severity of pedal oedema - right side: severe | 0 | 0 |
| Severity of pedal oedema - left side: trace | 4 | 5 |
| Severity of pedal oedema - left side: mild | 2 | 4 |
| Severity of pedal oedema - left side: moderate | 7 | 1 |
| Severity of pedal oedema - left side: severe | 0 | 0 |
| Severity of ankle oedema - right side: trace | 4 | 4 |
| Severity of ankle oedema - right side: mild | 5 | 6 |
| Severity of ankle oedema - right side: moderate | 7 | 1 |
| Severity of ankle oedema - right side: severe | 0 | 0 |
| Severity of ankle oedema - left side: trace | 4 | 6 |
| Severity of ankle oedema - left side: mild | 5 | 6 |
| Severity of ankle oedema - left side: moderate | 8 | 1 |
| Severity of ankle oedema - left side: severe | 0 | 0 |
| Severity of pretibial edema - right side: trace | 2 | 1 |
| Severity of pretibial edema - right side: mild | 4 | 2 |
| Severity of pretibial edema - right side: moderate | 5 | 1 |
| Severity of pretibial edema - right side: severe | 0 | 0 |
| Severity of pretibial edema - left side: trace | 1 | 2 |
| Severity of pretibial edema - left side: mild | 3 | 2 |
| Severity of pretibial edema - left side: moderate | 7 | 1 |
| Severity of pretibial edema - left side: severe | 0 | 0 |
| Severity of thigh edema - right side: trace | 0 | 0 |
| Severity of thigh edema - right side: mild | 0 | 0 |
| Severity of thigh edema - right side: moderate | 1 | 0 |
| Severity of thigh edema - right side: severe | 0 | 0 |
| Severity of thigh edema - left side: trace | 0 | 0 |
| Severity of thigh edema - left side: mild | 0 | 0 |
| Severity of thigh edema - left side: moderate | 1 | 0 |
| Severity of thigh edema - left side: severe | 0 | 0 |
Collected over Open-label Run-in Phase (OLP): includes treatment-emergent adverse events (TEAEs) that occurred during the OLP and all AEs which occurred prior to first dose of SZC which worsen in severity following dosing during the OLP, up to 4-6 weeks Randomised-withdrawal Phase (RWP): includes TEAEs that occurred during the RWP and up to 14 days after discontinuation of SZC/placebo and all AEs which occurred prior to first dose which worsen in severity following dosing during the RWP, up to 6.5 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open-label Run-in Phase | 7/362 (1.9%) | 11/362 (3%) | 9/362 (2.5%) |
| Randomized-withdrawal Phase - SZC Group | 2/101 (2%) | 23/101 (22.8%) | 20/101 (19.8%) |
| Randomized-withdrawal Phase - Placebo Group | 2/101 (2%) | 22/101 (21.8%) | 25/101 (24.8%) |
| Event | Open-label Run-in Phase | Randomized-withdrawal Phase - SZC Group | Randomized-withdrawal Phase - Placebo Group |
|---|---|---|---|
| Cardiac failureCardiac disorders | 4/362 | 12/101 | 4/101 |
| HyperkalaemiaMetabolism and nutrition disorders | 0/362 | 2/101 | 3/101 |
| PneumoniaInfections and infestations | 1/362 | 2/101 | 1/101 |
| Acute kidney injuryRenal and urinary disorders | 0/362 | 0/101 | 2/101 |
| Sudden cardiac deathGeneral disorders | 0/362 | 1/101 | 0/101 |
| Dengue feverInfections and infestations | 0/362 | 1/101 | 1/101 |
| Lower respiratory tract infectionInfections and infestations | 0/362 | 0/101 | 1/101 |
| OsteomyelitisInfections and infestations | 0/362 | 1/101 | 1/101 |
| Pulmonary sepsisInfections and infestations | 0/362 | 0/101 | 1/101 |
| Respiratory tract infectionInfections and infestations | 0/362 | 1/101 | 0/101 |
| Event | Open-label Run-in Phase | Randomized-withdrawal Phase - SZC Group | Randomized-withdrawal Phase - Placebo Group |
|---|---|---|---|
| HyperkalaemiaMetabolism and nutrition disorders | 6/362 | 12/101 | 23/101 |
| Oedema peripheralGeneral disorders | 3/362 | 6/101 | 2/101 |
| HypokalaemiaMetabolism and nutrition disorders | 0/362 | 6/101 | 0/101 |
| Age, Continuous(Years) | Randomized-withdrawal Phase - SZC Group | Randomized-withdrawal Phase - Placebo Group | Total |
|---|---|---|---|
| Mean | 72.5 ± 7.88 | 69.2 ± 10.46 | 70.9 ± 9.39 |
| Age, Customized(Participants) | Randomized-withdrawal Phase - SZC Group | Randomized-withdrawal Phase - Placebo Group | Total |
|---|---|---|---|
| 18-64 years | 18 | 32 | 50 |
| 65-84 years | 79 | 63 | 142 |
| >=85 years | 5 | 6 | 11 |
| Sex: Female, Male(Participants) | Randomized-withdrawal Phase - SZC Group | Randomized-withdrawal Phase - Placebo Group | Total |
|---|---|---|---|
| Female | 26 | 26 | 52 |
| Male | 76 | 75 | 151 |
| Ethnicity (NIH/OMB)(Participants) | Randomized-withdrawal Phase - SZC Group | Randomized-withdrawal Phase - Placebo Group | Total |
|---|---|---|---|
| Hispanic or Latino | 40 | 27 | 67 |
| Not Hispanic or Latino | 62 | 74 | 136 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Randomized-withdrawal Phase - SZC Group | Randomized-withdrawal Phase - Placebo Group | Total |
|---|---|---|---|
| White | 91 | 94 | 185 |
| Black or African American | 5 | 5 | 10 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| American Indian or Alaskan Native | 0 | 0 | 0 |
| Other | 6 | 2 | 8 |
| Not Reported | 0 | 0 | 0 |
| Country(Participants) | Randomized-withdrawal Phase - SZC Group | Randomized-withdrawal Phase - Placebo Group | Total |
|---|---|---|---|
| BRA | 31 | 19 | 50 |
| CAN | 7 | 16 | 23 |
| CZE | 3 | 13 | 16 |
| ESP | 33 | 26 | 59 |
| GBR | 9 | 4 | 13 |
| HUN | 5 | 5 | 10 |
| POL | 8 | 10 | 18 |
| USA | 6 | 8 | 14 |
| Type 2 diabetes at baseline(Participants) | Randomized-withdrawal Phase - SZC Group | Randomized-withdrawal Phase - Placebo Group | Total |
|---|---|---|---|
| Yes | 27 | 25 | 52 |
| No | 75 | 76 | 151 |
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
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Studies of the drug tested here: Sodium zirconium cyclosilicate