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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03813407
Other study ID # D9481C00001
Secondary ID 2018-001331-48
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 2, 2019
Est. completion date June 29, 2026

Study information

Verified date May 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Sodium zirconium cyclosilicate has been shown to be effective and safe in adults for the treatment of hyperkalaemia, and therefore it is expected to be beneficial in children. This study will evaluate the efficacy, safety and tolerability of sodium zirconium cyclosilicate for the treatment of hyperkalaemia in children <18 years of age. Approximately 140 participants will enter CP at approximately 46 sites in locations including but not limited to Europe and North America for this study. Treatment will include 3 phases: the CP, MP, and LTMP. Enrolment will start in 2 cohorts, ages 6 to < 12 years and 12 to < 18 years. After review of accumulated data, the independent Data Monitoring Committee (iDMC) will recommend whether to open enrolment in the ages 2 to < 6 years cohort and later in the ages 0 to < 2 years cohort. All eligible participants with hyperkalaemia will enter an open-label Correction Phase (CP) receiving a fixed dose of SZC three times daily (TID) for up to 3 days until normokalaemia is achieved. Within each age cohorts 2 to < 18 years, initial participants will be allocated to the dose level (DL) based on body weight equivalent to an adult 5 g TID. After recommendation of higher DLs by the iDMC, subsequent participants may be allocated in the CP to on body weight equivalent to an adult 10 g TID and then potentially on body weight equivalent to an adult 15 g TID. All participants in the ages 0 to < 2 years cohort will be assigned to the same DL which will be decided based on data from older age cohorts. Participants who successfully achieve normokalaemia in the CP will enter a 28-day open-label Maintenance Phase (MP), which will be initiated with once daily administration of the dose received TID in the CP. During MP, the Investigator is able to titrate the dose up or down in the range 2.5 g to 15 g body weight equivalent to maintain normokalaemia. For participants who, at the end of MP, are normokalaemic or hyperkalaemic without being on maximum dose, the MP is followed by the option to continue the study in a long term maintenance phase (LTMP) where the same titration regimen is used as in MP.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sodium Zirconium Cyclosilicate (SZC) Reduced Dose Level
Sodium Zirconium Cyclosilicate (SZC) Dose: Paediatric dose based on body weight equivalent to an adult 2.5 g
Sodium Zirconium Cyclosilicate (SZC) Dose Level 1 (DL1)
Sodium Zirconium Cyclosilicate (SZC)Paediatric dose based on body weight equivalent to an adult 5 g
Sodium Zirconium Cyclosilicate (SZC) Dose Level 2 (DL2)
Sodium Zirconium Cyclosilicate (SZC) Paediatric dose based on body weight equivalent to an adult 10 g
Sodium Zirconium Cyclosilicate (SZC) Dose Level 3 (DL3)
Sodium Zirconium Cyclosilicate (SZC) Paediatric dose based on body weight equivalent to an adult 15 g
Sodium Zirconium Cyclosilicate (SZC) Dose During 28 Day Maintenance Phase
A 28-day period during which SZC is administered orally once daily (QD) to maintain normokalaemia. A dose titration regimen starting with QD administration of the dose of SZC the participants received TID in the CP will be studied in the MP and continued in the LTMP. The maximum dose that can be used is the calculated body weight equivalent to the 15 g adult dose

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Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  China,  Germany,  Japan,  Poland,  Romania,  Russian Federation,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety objective: To evaluate the safety and tolerability of SZC in the 3 phases (CP, MP and LTMP) Adverse events/serious adverse events, Vital signs, Electrocardiogram, Clinical laboratory variables Throughout the study, 27 weeks
Other Tertiary/Exploratory objective: To evaluate the acceptability and palatability of SZC through the study Response categories in Study Medication Palatability Assessment questionnaires At certain timepoints throughout the study
Primary Correction phase (CP) primary objective: To evaluate the ability to achieve normokalaemia during the CP when initiating treatment with SZC of different dose levels in children with hyperkalaemia Normokalaemia achieved in the CP within 3 days (yes/no) 3 days
Primary 28-day Maintenance Phase (MP) primary objective: To evaluate the ability to maintain normokalaemia during the MP when continuing SZC treatment in children achieving normokalaemia 28-day MP primary endpoint: Serum potassium (S-K+) value within normokalaemia range (yes/no) at each of the last two scheduled visits in the MP last two scheduled visits in the MP
Secondary All phases secondary objective: To evaluate the change in S-K+ in children treated with SZC All phases secondary endpoint: S-K+ level at each scheduled visit at each scheduled visit
Secondary MP secondary objectives: To evaluate change in serum aldosterone levels in children treated with SZC during the MP MP secondary endpoints: Change in serum aldosterone levels from baseline to Week 3 of the MP from baseline to Week 3 of the MP
Secondary MP Secondary objective: To evaluate change in serum electrolytes (including bicarbonate), spot urinary pH and urinary electrolytes levels in children treated with SZC during the MP Change in serum electrolytes (including bicarbonate), and spot urinary pH and urinary electrolytes from baseline to week 3 of the MP from baseline to week 3 of the MP
Secondary Long-term MP (LTMP) secondary objectives: To evaluate the ability of maintaining normokalaemia in children treated with SZC during the LTMP LTMP secondary endpoints: S-K+ value within normokalaemia range (yes/no) at each scheduled visit in the LTMP at each scheduled visit
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04676646 - Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone Phase 4
Completed NCT04788641 - Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects Phase 1
Recruiting NCT05347693 - Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study Phase 4
Completed NCT05271266 - A Multicenter, Prospective, Non-interventional Cohort Study to Evaluate the Safety and Treatment Pattern of Sodium Zirconium Cyclosilicate for Hyperkalaemia Management in Real World Practice in China
Terminated NCT04727528 - Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease Phase 3
Recruiting NCT04249648 - Hyperkalaemia and Its Impact on Therapy With RAASi
Recruiting NCT06185660 - A National, Multicenter, Prospective, Observational Study to Assess Patient Characteristics, Treatment Algorithms and Disease Management of Hyperkalaemia Patients With Chronic Kidney Disease or Under Dialysis or With Heart Failure, Treated With Sodium Zirconium Cyclosilicate in Greece
Completed NCT05462119 - Safety of Oral Resin for Treatment of Hyperkalemia in Chinese Patients With Renal Insufficiency
Terminated NCT04997161 - Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia Phase 4