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Clinical Trial Details

Trial ID: L0453
Source ID: NCT05347693
Associated Drug: Sodium Zirconium Cyclosilicate (Szc)
Title: Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study
Acronym: CONTINUITY
Status: COMPLETED
Study Results: NO
Results:
Conditions: Hyperkalaemia|Chronic Kidney Disease
Interventions: DRUG: Sodium Zirconium Cyclosilicate (SZC)|DRUG: Local standard of care
Outcome Measures: Primary: Occurrence (yes/no) of normokalaemia (NK) (potassium [K+] between 3.5 and 5.0 mmol/L, inclusive), To evaluate the efficacy of continuing SZC as part of the discharge medications, compared to SoC, in maintaining NK, Up to 180 days post-discharge | Secondary: Time to first occurrence of all-cause hospital admissions or ED visits with HK as a contributing factor, all-cause death, or use of rescue therapy for HK, To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of the composite outcome 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, Up to 180 days post-discharge|Time to first occurrence of all-cause hospital admission or ED visit, with HK as a contributing factor, To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of hospital admissions or ED visit with HK as a contributing factor, Up to 180 days post-discharge|Number of all-cause hospital admission or ED visits, with HK as a contributing factor, To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the number of all-cause hospital admissions or ED visits with HK as a contributing factor, Up to 180 days post-discharge|Time to first occurrence of hospital admission or ED visit with HK as a contributing factor between the SZC and SoC arms., To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of hospital admissions or ED visits with HK as a contributing factor., Up to 180 days post-discharge|Incidence rate of hospital admission or ED visit with HK as a contributing factor between the SZC and SoC arms., To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the number of hospital admissions or ED visits with HK as a contributing factor., Up to 180 days post-discharge|Time to first occurrence of RAASi down-titration (or discontinuation), To evaluate the effect of continuing SZC as part of the discharge medications compared to SoC on reducing the risk of RAASi down-titration (or discontinuation), Up to 180 days post-discharge | Other: Adverse Events (AE), Assessments related to AEs cover: Occurrence/frequency, Relationship to SZC as assessed by investigator, Intensity, Seriousness, Death, AEs leading to discontinuation of SZC., From time of signature of the ICF, throughout the treatment period and including the follow-up period, 201 days maximum|Weight in kilograms, Weight will be measured using the same scale and in the same state of dress as part of vital signs, From time of signature of the ICF, throughout the treatment period and including the follow-up period, 201 days maximum|Height in centimeters, Height will be measured as part of vital signs., Height will be measured at screening visit|Blood pressure (BP) in mmHg, Blood pressure should be measured with a completely automated device in triplicate with at least 1-minute intervals between measurements after being comfortably at rest in a seated position with the back and feet supported quietly for at least 5 minutes. Manual techniques will be used only if an automated device is not available. The same device should preferably be used for the participant during the course of the study and in the same arm., From time of signature of the ICF, throughout the treatment period and including the follow-up period, 201 days maximum|Pulse rate in beats/min, Pulse rate should be measured with a completely automated device in triplicate with at least 1-minute intervals between measurements after being comfortably at rest in a seated position with the back and feet supported quietly for at least 5 minutes. Manual techniques will be used only if an automated device is not available. The same device should preferably be used for the participant during the course of the study and in the same arm., From time of signature of the ICF, throughout the treatment period and including the follow-up period, 201 days maximum|Clinical safety laboratory tests, Serum electrolytes values(mmol/L), serum BUN(mmol/L), urinalysis and others, From time of signature of the ICF, throughout the treatment period and the follow-up period, 201 days maximum|Electrocardiograms (ECG), An ECG will be performed throughout study participation and according to clinical judgment in connection with severe hypokalaemia (K+ \< 3.0 mmol/L), severe HK (K+ \> 6.0 mmol/L), or any symptoms or clinical events suggesting cardiac arrhythmia., From time of signature of the ICF, throughout the treatment period and the follow-up period, 201 days maximum|Time to first occurrence of any component of hospital admission or ED visit, both with HK as a contributing factor, or all-cause death, To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of the composite outcome of hospital admissions or ED visits with HK as a contributing factor or all-cause death, Up to 180 days post-discharge|Time to first occurrence of either hospital admission with HK as a contributing factor or allcause death, To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of hospital admissions with HK as a contributing factor or all-cause death, Up to 180 days post-discharge|Time to first occurrence of either ED visit with HK as a contributing factor or all-cause death, To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of ED visits with HK as a contributing factor or all-cause death, Up to 180 days post-discharge|Time to first occurrence of any component of all-cause hospitalisations, ED visits, use of rescue therapy for HK or all-cause death in each arm, To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of the composite outcome of all-cause hospitalisations, ED visits, all cause death, or use of rescue therapy for HK, Up to 180 days post-discharge|K+ level, To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, on mean K+ levels, Up to 180 days post-discharge|Number of hospital admissions with HK as a contributing factor, To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the number of hospital admissions with HK as a contributing factor, Up to 180 days post-discharge|Time to first occurrence of K-binder use in each arm, To evaluate the effect of continuing SZC as part of discharge medications, compared to SoC in reducing the incidence of K-binder use, Up to 180 days post-discharge|Frequency of the use of K-binder to treat HK in each arm, To evaluate the effect of continuing SZC as part of discharge medications, compared to SoC in reducing the frequency and duration of K-binder use, Up to 180 days post-discharge|Time to first occurrence of rescue therapy use in each arm, To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of rescue therapy for HK use, up to 180 days post-discharge|Time to first occurrence of all-cause hospitalisations, ED visits, or outpatient visits in each arm, To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of the composite outcome of all-cause hospitalisations, ED visits, or outpatient visits, up to 180 days post-discharge|Rate of change in (slope) eGFR (estimated glomerular filtration rate) from inpatient phase, To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in the change in eGFR, 90 and 180 days post-discharge|Time to first occurrence of dialysis initiation in each arm, To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in the incidence of dialysis initiation, up to 180 days post-discharge|Time to first occurrence of ICU (intensive care unit) admissions in each arm, To evaluate the effect of continuing SZC as part of the discharge medications, compared to SoC, in reducing the incidence of ICU admissions, up to 180 days post-discharge|Frequency (%) of participants on RAASi (renin-angiotensin-aldosterone system inhibitor) at discharge who remained on / increased / decreased / initiated RAASi, This exploratory endpoint will descriptively summarise the use of RAASi in each treatment arm, 90 and 180 days post-discharge
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 186
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-03-24
Completion Date: 2024-12-10
Results First Posted:
Last Update Posted: 2025-01-08
Locations: Research Site, Bonheiden, 2820, Belgium|Research Site, Leuven, 3000, Belgium|Research Site, Annonay, 07103, France|Research Site, Ars-Laquenexy, 57530, France|Research Site, Nice, 06000, France|Research Site, Saint-priest En Jarez, 42270, France|Research Site, Bari, 70120, Italy|Research Site, Foggia, 71122, Italy|Research Site, Parma, 43125, Italy|Research Site, Pavia, 27100, Italy|Research Site, Eindhoven, 5602 ZA, Netherlands|Research Site, Algeciras, 11207, Spain|Research Site, Almería, 04009, Spain|Research Site, Badajoz, 06080, Spain|Research Site, Barcelona, 08907, Spain|Research Site, Burgos, 9006, Spain|Research Site, Getafe, 28905, Spain|Research Site, Madrid, 28007, Spain|Research Site, Madrid, 28040, Spain|Research Site, Salamanca, 37007, Spain|Research Site, San Sebastián de los Reyes, 28702, Spain|Research Site, Sevilla, 41009, Spain|Research Site, Talavera de la Reina, 45600, Spain|Research Site, Zamora, 49022, Spain|Research Site, Doncaster, DN2 5LT, United Kingdom|Research Site, Hull, HU10 7AZ, United Kingdom|Research Site, Salford, M6 8HD, United Kingdom|Research Site, Stevenage, SG1 4AB, United Kingdom
URL: https://clinicaltrials.gov/show/NCT05347693