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    Summary
    EudraCT Number:2016-002785-31
    Sponsor's Protocol Code Number:RLY5016-206p
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-06-23
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2016-002785-31
    A.3Full title of the trial
    A Phase 2, Open-Label, Multiple Dose Study to Evaluate the Pharmacodynamic Effects, Safety, and Tolerability of Patiromer for Oral Suspension in Children and Adolescents 2 to < 18 Years of Age with Chronic Kidney Disease and Hyperkalemia (EMERALD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial to Evaluate the Effectivenes, Safety, and Tolerability of Patiromer for Oral Administration in Children and Adolescents aged 2 to < 18 Years with Chronic Kidney Disease and High Levels of Serum Potassium Concentration
    A.3.2Name or abbreviated title of the trial where available
    EMERALD
    A.4.1Sponsor's protocol code numberRLY5016-206p
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/027/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVifor 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 supportVifor Pharma, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVifor Pharma, Inc.
    B.5.2Functional name of contact pointEMERALD Clinical Study Team
    B.5.3 Address:
    B.5.3.1Street Address200 Cardinal Way
    B.5.3.2Town/ cityRedwood City
    B.5.3.3Post codeCA 94063
    B.5.3.4CountryUnited States
    B.5.4Telephone number001650421 9500
    B.5.6E-mailEMERALD.study@viforpharma.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 Yes
    D.2.1.1.1Trade name Veltassa®
    D.2.1.1.2Name of the Marketing Authorisation holderVifor Fresenius Medical Care Renal Pharma France
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namePatiromer
    D.3.2Product code RLY5016
    D.3.4Pharmaceutical form Powder for oral suspension
    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 INNPatiromer for oral suspension
    D.3.9.2Current sponsor codeRLY5016S
    D.3.9.3Other descriptive namePATIROMER
    D.3.9.4EV Substance CodeSUB182272
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number4.2
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Kidney Disease and Hyperkalemia
    E.1.1.1Medical condition in easily understood language
    Chronic Kidney Disease and High Levels of Potassium in the blood
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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
    To assess change from baseline in serum potassium levels to Day 14 following administration of different doses of patiromer administered once daily in children 2 – < 18 years of age with chronic kidney disease (CKD) and hyperkalemia.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of patiromer in children 2 – < 18 years of age with CKD and hyperkalemia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Written assent (when applicable) and written informed consent by a legally authorized representative provided prior to participation in the study
    2.Age 2 – < 18 years old (subject’s age should not exceed that of the age cohort into which s/he is enrolled for at least the entire 14 days of the PD / Dose Finding Phase)
    3.Pediatric subjects with CKD and eGFR < 90 mL/min/1.73m2 calculated using the Schwartz formula,(as described in Section 7.2), including renal transplant and peritoneal dialysis subjects, based on local creatinine measurement at Screening
    4.Two blood or serum potassium measurements of 5.1 to < 6.5 mEq/L performed on separate days
    5.In the opinion of the Investigator, the subject is expected to require treatment for hyperkalemia for at least 6 months
    6.If taking any renin-angiotensin aldosterone system inhibitors (RAASi), beta blockers, fludrocortisone or diuretic medications, must be on a stable dose for at least 28 days prior to Screening
    7.Females of child-bearing potential must be non-lactating, must have a negative pregnancy test at Screening, and must have used an effective form of contraception (e.g. abstinence, hormonal, chemical, physical barrier, etc.) for at least 1 month before patiromer administration. Subjects of child-bearing potential must agree to continue using contraception throughout the study and for 1 month after the last dose of patiromer
    E.4Principal exclusion criteria
    1.Subjects with pseudohyperkalemia due to hemolysis or to abnormally high numbers of platelets (> 500,000/mm³), leukocytes (> 70,000/mm³), or erythrocytes (hematocrit > 55%) at Screening based on results obtained locally
    2.Any subject with evidence of potential potassium-related ECG changes (i.e., changes consistent with hyper- or hypokalemia) at Screening
    3.Any of the following renal conditions: maintenance hemodialysis or peritoneal dialysis during the study, renal artery stenosis, and acute kidney injury (defined by 2012 Kidney Disease Improving Global Outcomes [KDIGO], 2012) or a history of acute renal insufficiency in the past 3 months
    4.A history of or current diagnosis of a severe gastrointestinal diagnosis or surgery that could affect gastrointestinal transit of the drug (e.g. a severe swallowing disorder, uncorrected pyloric stenosis, intussusception, any other intestinal obstruction [e.g., Hirschsprung disease, chronic intestinal pseudo-obstruction, clinically significant postsurgical abdominal adhesions] or any gut-shortening surgical procedure prior to Screening)
    5.A history of or current diagnosis of a condition that in the opinion of the investigator increases the risk of aspiration of patiromer if it will be given orally
    6.Liver enzymes [alanine aminotransferase (ALT), aspartate aminotransferase (AST) > three times upper limit of normal at Screening, based on the local laboratory ALT and AST
    7.Active cancer, currently on cancer treatment or history of cancer in the past 2 years (except for non-melanoma skin cancer)
    8.Heart or liver transplant recipient, or anticipated need for transplant during the study Treatment Period, including a scheduled kidney transplant recipient (note: patients currently on a kidney transplant wait list are not excluded unless there is an identified donor)
    9.Chronic alcohol abuse or substance use disorder within 1 year of Screening
    10.Subjects currently being treated with or having taken any one of the following medications (includes resins) in the 7 days prior to Screening: sodium or calcium polystyrene sulfonate, sodium zirconium cyclosilicate and drospirenone.
    11.Use of the following medications if doses have not been stable for at least 14 days prior to Screening or if doses are anticipated to change during the 14-day PD / Dose Finding Phase:
    -digoxin;
    -bronchodilators;
    -theophylline;
    -heparins (including low molecular heparins);
    -canagliflozin;
    -tacrolimus;
    -mycophenolate mofetil;
    -cyclosporine
    -trimethoprim or cotrimoxazole
    12.Use of any investigational product for an unapproved indication within 30 days prior to Screening or within 5 half-lives, whichever is longer
    13.Known hypersensitivity to patiromer or its components
    14.In the opinion of the Investigator, inability to comply with the protocol
    15.In the opinion of the Investigator, any medical condition, uncontrolled systemic disease, or serious intercurrent illness that would significantly decrease study compliance or jeopardize the safety of the subject or potentially affect the quality of the data such as: hyperkalemia at Screening that requires emergency intervention; cardiovascular event or intervention within 3 months prior to Screening; a hemodynamically unstable arrhythmia; hospitalization for heart failure (HF) within the past 3 months; poorly controlled blood pressure (BP); poorly controlled diabetes mellitus or frequent need for adjustment in insulin prescription or recent hospitalization for treatment of hyper or hypoglycemia
    E.5 End points
    E.5.1Primary end point(s)
    Change in serum potassium levels from baseline to Day 14.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14.
    E.5.2Secondary end point(s)
    Proportion of subjects with serum potassium levels in the range of 3.8 – 5.0 mEq/L at Day 14 (Initial Pharmacodynamic [PD] / Dose Finding Phase)

    Proportion of subjects with serum potassium levels in the range of 3.8 – 5.0 mEq/L by visit through Month 6 (Long-Term Treatment Phase)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 14.
    Month 6.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 No
    E.8.2.3Other No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Canada
    Georgia
    South Africa
    Ukraine
    United States
    Bulgaria
    Germany
    Poland
    E.8.7Trial has a data monitoring committee Yes
    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
    LPLV (Last Safety Visit)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months9
    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 Yes
    F.1.1Number of subjects for this age range: 54
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 36
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 18
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children 2 – < 18 years of age
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 54
    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)
    None
    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 Decision2017-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-05-13
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