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    The EU Clinical Trials Register currently displays   42732   clinical trials with a EudraCT protocol, of which   7035   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-004555-31
    Sponsor's Protocol Code Number:ZS-005
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-03-31
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2014-004555-31
    A.3Full title of the trial
    A Phase 3 Multicenter, Multi-dose, Open-label Maintenance Study to Investigate the Long-term Safety and Efficacy of ZS (Sodium Zirconium Cyclosilicate), an Oral Sorbent, in Subjects with Hyperkalemia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the long term safety and effectiveness of ZS (the study drug which is taken orally and acts by absorbing potassium) in patients with Hyperkalemia (excess potassium).
    A.4.1Sponsor's protocol code numberZS-005
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02163499
    A.5.4Other Identifiers
    Name:INDNumber:108951
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorZS Pharma Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportZS Pharma, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZS Pharma Inc
    B.5.2Functional name of contact pointDirector, Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address508 Wrangler Drive, Suite 100
    B.5.3.2Town/ cityCoppell
    B.5.3.3Post codeTX 75019
    B.5.3.4CountryUnited States
    B.5.6E-mailinfo@zspharma.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameZS
    D.3.2Product code ZS
    D.3.4Pharmaceutical form Oral suspension in sachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUNKNOWN
    D.3.9.1CAS number 242800-27-7
    D.3.9.2Current sponsor codeZS
    D.3.9.3Other descriptive nameSODIUM ZIRCONIUM CYCLOSILICATE
    D.3.9.4EV Substance CodeSUB121702
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameZS
    D.3.2Product code ZS
    D.3.4Pharmaceutical form Oral suspension in sachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUNKNOWN
    D.3.9.1CAS number 242800-27-7
    D.3.9.2Current sponsor codeZS
    D.3.9.3Other descriptive nameSODIUM ZIRCONIUM CYCLOSILICATE
    D.3.9.4EV Substance CodeSUB121702
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral suspension in sachet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hyperkalemia
    E.1.1.1Medical condition in easily understood language
    high levels of potassium ions in blood
    E.1.1.2Therapeutic area Body processes [G] - Cell Physiological Phenomena [G04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10020647
    E.1.2Term Hyperkalemia
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Open-Label Maintenance Study
    To generate open-label, long-term (up to 12 months) safety and tolerability data for ZS in subjects with hyperkalemia (serum potassium [S-K] ≥ 5.1 mmol/L).
    E.2.2Secondary objectives of the trial
    •To evaluate the proportion of ZS-treated subjects in whom normokalemia can be maintained over prolonged periods of time, using a dose range from 5 g every other day to 15 g once daily (qd).

    •To evaluate the effect of ZS on various renal and bone biomarkers over prolonged periods of time, using doses from 5 g every other day to 15 g qd.

    To evaluate the safety and tolerability of investigational product consumed in ~40 ml of water with no mandatory rinses and in ~180 ml of water with two ~30 ml rinses.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Provision of written informed consent.
    2.Age 18 years and older.
    3.For all subjects enrolled outside Germany: Two consecutive i STAT potassium values, measured 60 (+/-15) minutes apart, both ≥ 5.1 mmol/L and measured within 1 day before the first dose of ZS on Acute Phase Study Day 1.
    For all subjects enrolled in Germany: Two consecutive i-STAT potassium
    values, measured 60 (± 15) minutes apart, both ≥ 5.1 mmol/L and ≤ 6.5
    mmol/L and measured within 1 day before the first dose of ZS on Acute
    Phase Study Day 1.
    4.Ability to have repeated blood draws or effective venous catheterization.
    5.For all subjects outside the European Union: Women of childbearing
    potential must have a negative pregnancy test within 1 day prior to the
    first dose of ZS on Acute Phase Study Day 1 and sexually active women
    of childbearing potential must be using 2 forms of medically acceptable
    contraception with at least one being a barrier method. Women who are
    surgically sterile or those who are postmenopausal for at least 2 years
    are not considered to be of childbearing potential.
    For all subjects in the European Union: Women of childbearing potential must have a negative pregnancy test within 1 day prior to the first dose of ZS on Acute Phase Study Day 1 and sexually active women of childbearing potential must be using a highly effective medically acceptable contraception such as:
    • combined or hormonal contraception associated with inhibition of ovulation
    • progesterone only hormonal contraception, associated with inhibition of ovulation
    • IUD (intrauterine device)
    • IUS (intrauterine hormone-releasing system)
    • bilateral tubal occlusion
    • vasectomised partner
    • sexual abstinence (True abstinence in line with the subjects preferred and usual lifestyle. Subjects practicing abstinence will agree to have a documented second acceptable method of birth control should they become sexually active during the course of study participation)
    Women who are surgically sterile or those who are postmenopausal for at least 2 years are not considered to be of childbearing potential.

    Note: Controlled diabetic subjects are eligible for enrollment. Whenever possible, all blood draws collected before meals should be collected prior to insulin/insulin analog treatment.
    E.4Principal exclusion criteria
    1.Pseudohyperkalemia signs and symptoms, such as hemolyzed blood specimen due to excessive fist clenching to make veins prominent, difficult or traumatic venipuncture, or history of severe leukocytosis or thrombocytosis.
    2.Subjects treated with lactulose, Rifaximin, or other non-absorbed antibiotics for hyperammonemia within 7 days prior to first dose of ZS on Acute Phase Study Day 1.
    3.Subjects treated with sodium polystyrene sulfonate (SPS; eg, Kayexalate®) or calcium polystyrene sulfonate (eg, Resonium) within 3 days prior to first dose of ZS on Acute Phase Study Day 1.
    4.Subjects with a life expectancy of less than 12 months.
    5.Subjects who are severely physically or mentally incapacitated and who, in the opinion of investigator, are unable to perform the subjects’ tasks associated with the protocol.
    6.Women who are pregnant, lactating, or planning to become pregnant.
    7.Subjects with diabetic ketoacidosis.
    8.Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated.
    9.Known hypersensitivity or previous anaphylaxis to ZS or to components thereof.
    10.Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry.
    11.Subjects with cardiac arrhythmias that require immediate treatment.
    12.Subjects on dialysis.
    13.Subjects randomized into the previous ZS-002, ZS-003, ZS-004, or ZS-004E studies.
    14. Documented GFR < 15 mL/min within 90 days prior to study entry.
    15. For Germany only: Subjects presenting with QTc Interval of 450 ms
    AND additional risk factors for Torsade de pointes (e.g. heart failure or
    family history of long QT-syndrome) AND taking concomitant
    medications causing QT prolongation.
    16. For Germany only: Patients who are committed to an institution by
    virtue of an order issued either by the judicial or the administrative
    authorities.
    17. For Germany only: Subjects who are dependents of either the
    Sponsor, Investigator or Institution.
    E.5 End points
    E.5.1Primary end point(s)
    Open-Label Maintenance Study: The primary endpoint will be safety and tolerability as measured by adverse event reporting, vital signs, ECGs, physical examinations, and safety laboratory measurements.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Open-Label Maintenance Study:
    AEs are collected and potassium levels measured at every visit
    Vital signs, ECGs, physical examinations, and safety laboratory measurements are measured on Study days 8, 15, 22, 29, 57, 85, 176, 267 and 365
    E.5.2Secondary end point(s)
    •The proportion of subjects with average S-K equal to or less than 5.1 mmol/l between Month 3 and Month 12.
    •The proportion of subjects who maintain or achieve normal aldosterone values (normal range: 4.0 to 31.0 ng/dL) on ZS at Study Days 85, 176, and 365
    • Change from Acute Phase and Maintenance Phase baselines in S-K
    levels at all measured Maintenance Phase Study Days
    • Change in Serum-bicarbonate from Acute Phase baseline at all
    measured Maintenance Phase Study Days
    E.5.2.1Timepoint(s) of evaluation of this end point
    Study Days 85, 176, 267, and 365
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    France
    Germany
    Netherlands
    Poland
    Romania
    South Africa
    Sweden
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 385
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 365
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 750
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will receive standard of care treatment following participation in the study
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-04
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