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A Study in Children With Hyperkalaemia Between Birth and <18 Years of Age to Evaluate Doses of Sodium Zirconium Cyclosilicate (SZC) for Correction of Hyperkalaemia and Effectiveness of Same Dose to Maintain Normokalaemia.

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ClinicalTrials.gov Identifier: NCT03813407
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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.

Primary Objective:28-day maintenance phase (MP) primary objective:

To compare the effect of SZC vs placebo on maintaining normokalaemia during the MP.

Correction phase (CP) primary objective:

To evaluate SZC efficacy of different dose levels on achieving normokalaemia during the CP.

Overall design:

Approximately 140 participants will be enrolled at approximately 40 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. Participants from 2 to <18 years are eligible to participate in all phases of the study. Participants <2 years of age will be included in the first 2 phases, namely the CP and the MP.

During the study, participants are recommended to be fasting prior to any visit pre-dose laboratory testing. All laboratory tests are taken pre-dose except select post dose K+ values during the CP. Electrocardiograms are to be taken prior to dosing. On visit days, the study treatment is to be taken at the site (during the CP this pertains only to the morning dose). For participants with diabetes, K+ measurements should be performed prior to insulin administration where possible.

For inclusion into the study and for determining the ≥0.5 mmol/L decrease in K+, i-STAT is used. For subsequent decisions on eligibility and determination of hyper and normokalaemia for entry into the MP and LTMP phases, local laboratory K+ is the determinant value.

Tolerability and safety will be assessed using AE reporting, results from laboratory testing, vital signs, physical examinations and ECG findings during the study. Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open ended non leading verbal questioning of the participant or participant's legal representative, as appropriate, is the preferred method to inquire about AE occurrences.

Participants are allowed to discontinue the study treatment and assessments at any time or at the discretion of the Investigator(s). The independent Data Monitoring Committee (iDMC) will monitor data during all phases of the study including DL evaluations.


Condition or disease Intervention/treatment Phase
Hyperkalaemia Drug: Sodium Zirconium Cyclosilicate (SZC) Reduced Dose Level Drug: Sodium Zirconium Cyclosilicate (SZC) Dose Level 1 (DL1) Drug: Sodium Zirconium Cyclosilicate (SZC) Dose Level 2 (DL2) Drug: Sodium Zirconium Cyclosilicate (SZC) Dose Level 3 (DL3) Drug: Sodium Zirconium Cyclosilicate (SZC) Dose During 28 Day Maintenance Phase Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Treatment will include 3 phases: the CP, MP, and LTMP. Participants from 2 to <18 years are eligible to participate in all phases of the study. Participants <2 years of age will be included in the first 2 phases, namely the CP and the MP.

Of the 140 participants enrolled, ≥5 participants should be in the birth to <2 years cohort. Additionally, the 90 (or greater) participants randomised into the MP should include ≥30 participants in the 12 to <18 years cohort, ≥30 participants in the 6 to <12 years cohort, and ≥10 participants in the 2 to <6 years cohort. At least 45 participants randomised in the MP should have a Screening i-STAT-K+ level (using the mean of the 2 consecutive i-STAT-K+ measurements at Screening) of >5.5 mmol/L. A minimum number of 75 participants must continue study treatment throughout the MP (≥25 participants in the 12 to <18 years cohort, ≥25 participants in the 6 to <12 years cohort, and ≥8 participants in the 2 to <6 years cohort).

Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: This study consist of double blinded treatment as well as open label treatment.
Primary Purpose: Treatment
Official Title: A Phase 3, Dose-Escalating Study in Children With Hyperkalaemia Between Birth and <18 Years of Age to Evaluate Increasing Doses of Sodium Zirconium Cyclosilicate (SZC) Given Three Times Daily for the Correction of Hyperkalaemia and the Effectiveness of the Same Dose of SZC Given Once Daily to Maintain Normokalaemia Among Those Requiring Continuous Treatment.
Actual Study Start Date : April 2, 2019
Estimated Primary Completion Date : March 22, 2023
Estimated Study Completion Date : March 22, 2023

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Arm Intervention/treatment
Experimental: Active Arm ( Sodium Zirconium Cyclosilicate SZC)

This study will enrol males and females with hyperkalaemia in age cohorts of birth to 18 years of age, except neonates with a gestational age less than 37 weeks at birth or a birth weight less than 2500 g.

Treatment will include 3 phases: the CP, MP, and LTMP. Participants from 2 to <18 years are eligible to participate in all phases of the study and will be randomised in a 1:1 ratio to either SZC or placebo treatment. Continuation into LTMP is optional and will be determined by the Investigator based on the participant's need for long-term treatment in addition to the K+ measurements.

Participants <2 years of age will be included in the first 2 phases and will not be randomised to treatment with SZC or placebo after completing the CP, but may instead continue open label QD active treatment during the MP for up to 28 days if meeting the eligibility criteria.

Drug: Sodium Zirconium Cyclosilicate (SZC) Reduced Dose Level

Sodium Zirconium Cyclosilicate (SZC) Dose:

To be considered by the iDMC in consultation with the Sponsor, if de-escalation is indicated by evaluation of safety/tolerability data


Drug: Sodium Zirconium Cyclosilicate (SZC) Dose Level 1 (DL1)
Sodium Zirconium Cyclosilicate (SZC)Paediatric dose based on body weight equivalent to an adult 5 g TID (CP) or QD (MP/LTMP) dose

Drug: Sodium Zirconium Cyclosilicate (SZC) Dose Level 2 (DL2)
Sodium Zirconium Cyclosilicate (SZC) Paediatric dose based on body weight equivalent to an adult 10 g TID (CP) or QD (MP/LTMP) dose

Drug: Sodium Zirconium Cyclosilicate (SZC) Dose Level 3 (DL3)
Sodium Zirconium Cyclosilicate (SZC) To be considered by the iDMC in consultation with the Sponsor if further dose escalation/de-escalation is indicated by evaluation of safety/tolerability and efficacy data

Drug: Sodium Zirconium Cyclosilicate (SZC) Dose During 28 Day Maintenance Phase
A 28-day MP during which Sodium Zirconium Cyclosilicate ( SZC) or placebo is administered in a randomised, double-blind manner orally once daily (QD) to maintain normokalaemia in particpants from 2 to <18 years. Participants aged <2 years will continue treatment in the MP with open-label QD oral SZC active treatment if medically indicated by the treating physician.

Placebo Comparator: Placebo Arm
To compare the effect of SZC vs placebo on maintaining normokalaemia during the MP.28-day maintenance phase (MP) primary endpoint (primary analysis endpoint): The proportion of participants in whom normokalaemia can be maintained throughout the MP.
Drug: Sodium Zirconium Cyclosilicate (SZC) Dose During 28 Day Maintenance Phase
A 28-day MP during which Sodium Zirconium Cyclosilicate ( SZC) or placebo is administered in a randomised, double-blind manner orally once daily (QD) to maintain normokalaemia in particpants from 2 to <18 years. Participants aged <2 years will continue treatment in the MP with open-label QD oral SZC active treatment if medically indicated by the treating physician.




Primary Outcome Measures :
  1. 28-day maintenance phase (MP) primary endpoint (Primary Analysis Endpoint): The proportion of participants in whom normokalaemia can be maintained throughout the MP. [ Time Frame: 28 Days ]
    The proportion of participants in whom normokalaemia can be maintained throughout the Maintenance phase.

  2. Correction phase (CP) primary endpoint: The proportion of participants in whom S-K+ decreases by ≥0.5 mmol/L and who achieve normokalaemia at (by or before) 24, 48 and 72 hours during Correction Phase. [ Time Frame: 24, 48 and 72 Hours ]
    The proportion of participants in whom S-K+ decreases by ≥0.5 mmol/L and who achieve normokalaemia at (by or before) 24, 48 and 72 hours during Correction Phase.


Secondary Outcome Measures :
  1. Correction Phase secondary endpoints The proportion of participants in whom S-K+ decreases by ≥0.5 mmol/L and who achieve normokalaemia during the first 72 hours [ Time Frame: 72 hours ]
    The proportion of participants in whom S-K+ decreases by ≥0.5 mmol/L and who achieve normokalaemia during the first 72 hours.

  2. Maintenance Phase secondary endpointsTime from randomization to relapse of hyperkalaemia.: [ Time Frame: 28 Days ]
    Time from randomisation to relapse of hyperkalaemia in each treatment group

  3. Maintenance Phase Secondary endpoint. Proportion of participants within each treatment group who maintain normal S-K+ levels . [ Time Frame: 28 days ]
    Proportion of participants within each treatment group who maintain normokalaemia per visit over the MP

  4. Maintenance Phase Secondary End Point. Absolute change from base line in S-K+ levels post dose during MP and at any time point thereafter in each treatment group. [ Time Frame: 28 days ]
    Absolute change from baseline in S-K+ levels post dose during the MP and at any time point thereafter in each treatment group

  5. Maintenance Phase Secondary End Point. Time to an increase in S-K+ concentration of 0.5 mmol/L in each treatment group. [ Time Frame: 28 Days ]
    Time to an increase in S-K+ concentration of ≥0.5 mmol/L in each treatment group

  6. Maintenance Phase Secondary End point. The difference in mean of all S-K values obtained during the MP in subjects receiving either SZC or placebo. [ Time Frame: 28 Days ]
    The difference in mean of all S-K+ values obtained during the MP in participants receiving either SZC or placebo

  7. Maintenance Phase Secondary End Point Percentage of subjects with hypokalaemia in subjects receiving either SZC or Placebo [ Time Frame: 28 Days ]
    The number and percentage of participants with hypo- or hyperkalaemia in participants receiving either SZC or placebo

  8. Maintenance Phase Secondary End point. Change from baseline in S-Aldo to end of the MP [ Time Frame: 28 Days ]
    Change from baseline in S-Aldo to end of the MP

  9. Maintenance Phase Secondary Endpoint. Proportion of patients per response category in Study Medication Palatability Assessment questionnaires. [ Time Frame: 28 Days ]
    Proportion of participants per response category in Study Medication Palatability Assessment questionnaires (self-reported or observer assessment)

  10. Maintenance Phase Secondary End poinPercentage of days of normokalaemia. [ Time Frame: 28 Days ]
    Number and percentage of days of normokalaemia

  11. Long Term Maintenance Phase secondary endpointsProportion of participants in whom normokalaemia can be maintained over the LTMP. [ Time Frame: 22 Weeks ]
    Proportion of participants in whom normokalaemia can be maintained over the LTMP.

  12. Long Term Maintenance Phase Secondary End Proportion of participants who needed dose escalation/de-esclation to higher dose levels during the LTMP. [ Time Frame: 22 weeks ]
    Proportion of participants who needed dose escalation/de-escalaion to higher dose levels during the LTMP

  13. Long Term Maintenance Phase Secondary End PointProportion of participants who needed dose de-escalation to lower dose levels during the LTMP [ Time Frame: 22 Weeks ]
    Proportion of participants who needed dose de-escalation to lower dose levels during the LTMP

  14. Long Term Maintenance Phase Secondary End Point Percentage of participants with hypokalaemia during LTMP [ Time Frame: 22 Weeks ]
    The percentage of subjects with hypokalaemia during the LTMP.

  15. Long Term Maintenance Phase Secondary End PoinProportion of participants per response category in Study Medication Palatability Assessment. [ Time Frame: 22 weeks ]
    Proportion of participants per response category in Study Medication Palatability Assessment questionnaires (self reported or observer assessment)

  16. Correction Phase Secondary enpoints Time to first day achievement of normokalaemia [ Time Frame: From date of first dose in the Correction Phase to date of first date of normokalaemia, or date of censoring as applicable, assessed up to 72 hours ]
    Time to first day achievement of normokalaemia

  17. Correction Phase Secondary Endpoint Absolute change from baseline in serum K levels at all intervals of follow-up [ Time Frame: At baseline and at 24, 48 and 72 hours ]
    Absolute change from baseline in serum K levels at all intervals of follow-up after dosing has been initiated

  18. Correction Phase Secondary End Point Time to decrease of 0.5 mmol/L in serum K level [ Time Frame: From date of first dose in the CP to date of first date of decrease of ≥0.5 mmol/L, or date of censoring as applicable, assessed up to 72 hours" ]
    Time to decrease of 0.5 mmol/L in serum K level

  19. Correction Phase Secondary EndpointProportion of patients per response category in Study Medication Palatability Assessment questionnaires. [ Time Frame: At baseline and 48 hours ]
    Proportion of patients per response category in Study Medication Palatability Assessment questionnaires (self reported or observer assessment)

  20. Maintenance Phase Secondary Endpoint Change from Baseline in Sodium (plasma electrolytes.) [ Time Frame: 28 Days ]
    Change from Baseline to Visit 7 For Sodium (Plasma Electrolyte)

  21. Maintenance Phase Secondary Endpoint Change from Baseline in Potassium (plasma electrolytes.) [ Time Frame: 28 Days ]
    Change from Baseline to Visit 7 For Potassium (Plasma Electrolyte)

  22. Maintenance Phase Secondary Endpoint Change from Baseline in Calcium ( plasma electrolytes.) [ Time Frame: 28 Days ]
    Change from Baseline to Visit 7 For Calcium (Plasma Electrolyte)

  23. Maintenance Phase Secondary Endpoint Change from Baseline in Phosphrous ( plasma electrolytes.) [ Time Frame: 28 Days ]
    Change from Baseline to Visit 7 For Phosphrous (Plasma Electrolyte)

  24. Maintenance Phase Secondary Endpoint Change from Baseline in Megnesium ( plasma electrolytes.) [ Time Frame: 28 Days ]
    Change from Baseline to Visit 7 For Megnesium (Plasma Electrolyte)

  25. Correction Phase Secondary Endpoint Percent change from baseline in serum K levels at all intervals of follow up [ Time Frame: At Baseline and at 24, 48 and 72 Hours ]
    Percentage change from base in serum K levels at all intervals of follow up after dosing has been initiated.

  26. percent change from baseline in serum K levels post dose during the MP and at any time point thereafter in each treatment group [ Time Frame: 28 Days ]
    Percent change from baseline in serum K levels post dose during the MP and at any time point thereafter in each treatment group

  27. The percentage of subjects with hyperkalaemia in participants receiving either SZC or placebo. [ Time Frame: 28 Days ]
    The percentage of subjects with hyperkalaemia in participants receiving either SZC or placebo

  28. Maintenance phase secondary end point change from baseline in Bicarbonate (plasma electrolytes) [ Time Frame: 28 days ]
    Change from Baseline to Visit 7 For Bicarbonate (plasma electrolytes)

  29. Maintenance Phase Secondary Endpoint Change from Baseline in Spot Urine PH [ Time Frame: 28 Days ]
    Change from Baseline to Visit 7 For Spot Urine PH.

  30. Maintenance Phase Secondary End Point percentage of days of normokalaemia [ Time Frame: 28 Days ]
    Percentage of days of normokalaemia.

  31. Long Term Maintenance Phase Secondary End PoinProportion of patients per response category in Study Medication Palatability Assessment. [ Time Frame: 22 weeks ]
    Proportion of patients per response category in Study Medication Palatability Assessment questionnaires (self reported or observer assessment)

  32. Long Term Maintenance Phase Secondary End Point Percentage of participants with hyperkalaemia during LTMP. [ Time Frame: 22 Weeks ]
    The percentage of participants with hyperkalaemia during the LTMP.

  33. Maintenance Phase Secondary Endpoint Change from Baseline in Spot Urine Sodium [ Time Frame: 28 Days ]
    Change from Baseline to Visit 7 For Spot urine Sodium.

  34. Maintenance Phase Secondary Endpoint Change from Baseline in Spot Urine Potassium [ Time Frame: 28 Days ]
    Change from Baseline to Visit 7 For Spot urine Potassium.

  35. Maintenance Phase Secondary Endpoint Change from Baseline in Spot Urine Bicarbonate [ Time Frame: 28 Days ]
    Change from Baseline to Visit 7 For Spot urine Bicarbonate.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of written informed consent of the participant or legal representative, and informed assent from the participant (as appropriate).
  2. Female or male from birth to <18 years of age.
  3. Participants (including those receiving peritoneal dialysis) requiring long term treatment of hyperkalaemia (chronic hyperkalaemia) in the age cohort ≥2 years, and participants requiring either short- or long-term treatment for hyperkalaemia (acute and chronic hyperkalaemia) in the age cohort <2 years.
  4. Participants must meet 1 of the following criteria for hyperkalaemia:

    1. For participants ≥2 years of age, mean i STAT K+ level >5.0 mmol/L at Screening. Two consecutive i STAT K+ values, measured 60 (±15) minutes apart, both >5.0 mmol/L and measured within 1 day before the first dose of SZC on CP Study Day 1.
    2. For participants <2 years of age, i STAT K+ level >6.0 mmol/L at Screening, measured within 1 day before the first dose of SZC on CP Study Day 1.

    Note that if Day 1 is the same as the Screening day, the 60 (±15) minute K+ value is the same as the Day 1 time 0 K+ value. However, if Day 1 is not the same day as Screening, then the participant will actually have 3 i STAT-K+ values measured before starting treatment in the CP and the third value which is taken on Day 1 time 0 must also be hyperkalaemic.

  5. Using digital ECG, QT interval corrected by Bazett's method (QTcB) must meet the age-appropriate parameters at Screening:

    1. For participants aged 0 to ≤3 days after birth: <450 ms
    2. For participants aged >3 days to <12 years: <440 ms
    3. For participants ≥12 to <18 years: <450 ms (male), <460 ms (female) All QTcB values outside the reference values specified in the protocol should be manually re-measured and re-calculated, and if there is a difference in measurement between the automatic and manual ECG, the manual measurement should always be considered correct.
  6. Ability to have repeated blood draws or effective venous catheterization.
  7. Females of childbearing potential must have a negative pregnancy test within 1 day prior to the first dose of SZC on CP Study Day 1 and sexually active females of childbearing potential must be using 2 forms of medically acceptable contraception with at least 1 being a barrier method

Exclusion Criteria:

  1. Neonates with a gestational age <37 weeks at birth or a birth weight <2500 g.
  2. Term and preterm neonates with suspected conditions predisposing them to intestinal ischemia (eg, perinatal hypoxia or sepsis).
  3. Participants with pseudohyperkalaemia caused by excessive fist clenching to enable venepuncture, by haemolysed blood specimens, or by severe leukocytosis or thrombocytosis.
  4. Participants with hyperkalaemia due to soft-tissue damage from crush injury or burns.
  5. Participants with hyperkalaemia due to a secondary cause, such as dehydration, excessive use of K+ supplements, or drug use (eg, beta-adrenergic antagonists) and that would be more appropriately treated with other interventions (eg, fluid resuscitation, dose adjustments of medications).
  6. Participants treated with lactulose, rifaximin (XIFAXAN™), or other nonabsorbed antibiotics for hyperammonaemia within the last 7 days.
  7. Participants treated with CPS, sodium polystyrene sulfonate (eg, KAYEXALATE™), or patiromer within the last 4 days.
  8. Participants with a life expectancy of less than 3 months.
  9. Participants who are known to have tested Human Immunodeficiency Virus (HIV) positive.
  10. Presence of any condition which, in the opinion of the Investigator, places the participant at undue risk or potentially jeopardises the quality of the data to be generated.
  11. Known hypersensitivity or previous anaphylaxis to SZC or to components thereof.
  12. Participants with cardiac arrhythmias that require immediate treatment.
  13. Participants with a family history of long QT syndrome.
  14. Participants on haemodialysis.
  15. Participants with a history of bowel obstruction.
  16. Participants with severe gastrointestinal disorder or major gastrointestinal surgery (eg, large bowel resection).
  17. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
  18. Previous treatment with SZC.
  19. Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry.
  20. Previous enrolment in the present study.
  21. Females who are pregnant, breastfeeding, or planning to become pregnant.
  22. Judgment by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.
  23. For the LTMP only: participants who are normokalaemic at Visit 8b and are receiving placebo at Visit 8a of the MP unless they received rescue treatment.
  24. If the participant has evidence of Coronavirus disease 2019 (COVID-19) within 2 weeks prior to enrolment (a positive COVID-19 test or suspicion of COVID-19 infection) the participant cannot be enrolled in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03813407


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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United States, Alabama
Research Site Recruiting
Birmingham, Alabama, United States, 35233
United States, California
Research Site Withdrawn
Los Angeles, California, United States, 90095
United States, Georgia
Research Site Suspended
Atlanta, Georgia, United States, 30322
United States, Kentucky
Research Site Withdrawn
Louisville, Kentucky, United States, 40202
United States, Maryland
Research Site Recruiting
Baltimore, Maryland, United States, 21287
United States, Missouri
Research Site Suspended
Saint Louis, Missouri, United States, 63104
United States, New Jersey
Research Site Suspended
Hackensack, New Jersey, United States, 07601
United States, New York
Research Site Suspended
Stony Brook, New York, United States, 11794
United States, North Carolina
Research Site Suspended
Charlotte, North Carolina, United States, 28207
Research Site Suspended
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Research Site Recruiting
Akron, Ohio, United States, 44308
United States, Texas
Research Site Withdrawn
Dallas, Texas, United States, 75235
United States, Utah
Research Site Withdrawn
Salt Lake City, Utah, United States, 84113
United States, West Virginia
Research Site Suspended
Morgantown, West Virginia, United States, 26506-7900
Canada, Alberta
Research Site Suspended
Calgary, Alberta, Canada, T3B 6A8
Research Site Suspended
Edmonton, Alberta, Canada, T6G 1C9
Italy
Research Site Withdrawn
Milano, Italy, 20122
Poland
Research Site Suspended
Bialystok, Poland, 15-089
Research Site Suspended
Krakow, Poland, 30-663
Research Site Suspended
Warszawa, Poland, 02-091
Research Site Suspended
Łódź, Poland, 93-338
Romania
Research Site Suspended
Bucuresti, Romania, 077120
Research Site Suspended
Bucuresti, Romania, 22328
Research Site Suspended
Cluj-Napoca, Romania, 400177
Research Site Suspended
Targu Mures, Romania, 540136
Russian Federation
Research Site Withdrawn
Moscow, Russian Federation, 107014
Research Site Suspended
Samara, Russian Federation, 443095
Ukraine
Research Site Suspended
Dnipropetrovsk, Ukraine, 49100
Research Site Suspended
Kharkiv Region, Ukraine, 61075
Research Site Suspended
Kiev, Ukraine, 1103
Research Site Suspended
Odesa, Ukraine, 65038
Research Site Suspended
Sumy, Ukraine, 40031
Research Site Suspended
Zaporizhzhia, Ukraine, 69063
United Kingdom
Research Site Suspended
Glasgow, United Kingdom, G51 4TF
Research Site Suspended
Manchester, United Kingdom, M13 9WL
Research Site Suspended
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03813407    
Other Study ID Numbers: D9481C00001
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
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 refer 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 de-identified 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.

URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
sodium zirconium cyclosilicate
Hyperkalaemia in children
Additional relevant MeSH terms:
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Hyperkalemia
Water-Electrolyte Imbalance
Metabolic Diseases