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    Summary
    EudraCT Number:2012-001956-20
    Sponsor's Protocol Code Number:RLY5016-301
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-16
    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 number2012-001956-20
    A.3Full title of the trial
    A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia
    Единично-сляпо, от две части, фаза 3 изпитване, оценяващо ефикасността и безопасността на патиромер при лечение на хиперкалиемия
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to test the effects and safety levels of Patiromer in patients with high levels of potassium in the blood.
    A.4.1Sponsor's protocol code numberRLY5016-301
    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 SponsorRelypsa 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 supportRelypsa Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWorldwide Clinical Trials Ltd
    B.5.2Functional name of contact pointNancy Newark
    B.5.3 Address:
    B.5.3.1Street Address3800 Paramount Parkway, Suite 400
    B.5.3.2Town/ cityMorrisville, NC
    B.5.3.3Post code27560
    B.5.3.4CountryUnited States
    B.5.4Telephone number+0019196742904
    B.5.5Fax number+0019194653820
    B.5.6E-mailnancy.newark@wwctrials.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 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 INNNot available
    D.3.9.1CAS number Applying for
    D.3.9.2Current sponsor codeRLY5016S
    D.3.9.3Other descriptive namecalcium-sorbitol 2-fluoroacrylate-divinylbenzene-1,7-octadiene copolymer, crosslinked
    D.3.9.4EV Substance CodeSUB33113
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for oral suspension
    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
    Elevated potassium levels in the blood
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    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
    Part A:
    To evaluate the efficacy and safety of patiromer for the treatment of hyperkalemia.
    Part B:
    To evaluate the effect of withdrawing patiromer on serum potassium control;
    To assess whether chronic treatment with patiromer prevents the recurrence of hyperkalemia
    To provide placebo-controlled safety data.
    E.2.2Secondary objectives of the trial
    n/a
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All subjects must have CKD and be on any dose of at least one RAAS inhibitor medication at Screening. Subjects must also have pre-existing hyperkalemia.
    Part A - Inclusion Criteria:
    Subjects in Part A must meet ALL the following criteria:
    1.Age 18 – 80 years old at screening.
    2.Chronic kidney disease: eGFR 15 to < 60 mL/min/1.73m2 at screening (calculated using the CKD-EPI formula or the MDRD formula): the local lab serum creatinine value will be used to assess this entry criterion.
    3.Females of child-bearing potential must be non-lactating, must have a negative serum pregnancy test at screening, and must have used a highly effective form of contraception for at least 3 months before patiromer administration. Female subjects must agree to continue using contraception throughout the study and for one month after study completion.
    4.Provide written informed consent prior to participation in the study.
    5.Serum Potassium: the local laboratory serum K+ value of 5.1 to < 6.5 mEq/L at screening.
    6.On any stable dose of at least one RAAS inhibitor medication (an ACEI, ARB, or AA) for at least 28 days prior to screening.
    7.If on anti-hypertensive medications, have a stable dose for 28 days prior to screening.
    Part B - Inclusion Criteria
    To be eligible for Part B, subjects must meet ALL of the following:
    1.Completed Part A, the Patiromer Treatment Phase AND
    2.Have a Part A baseline central laboratory serum K+ ≥ 5.5 mEq/L
    3.Have a locally measured serum K+ value at the Part A Week 4 Visit (AW4) in the target range of 3.8 to < 5.1 mEq/L AND
    4.Be on 8.4 to 50.4 g/d patiromer AND
    5.Still receiving treatment with a RAAS inhibitor medication at the Part A Week 4 Visit (AW4).
    E.4Principal exclusion criteria
    Part A - Exclusion Criteria
    Subjects in Part A must NOT meet ANY of the following exclusion criteria:
    1.Subjects with any level of hyperkalemia at screening that, in the opinion of the investigator, requires emergency intervention.
    2.Any subject with potassium-related ECG changes at Screening.
    3.Subjects with auto-immune related chronic kidney disease such as lupus nephritis, renal scleroderma/scleroderma renal crisis, or mixed connective tissue disease with renal involvement.
    4.Type 1 diabetes or a hemoglobin A1c (HbA1c) measurement of > 10.0% within the previous 6 months in subjects with type 2 diabetes (T2DM).
    5.Hospitalization (either in-patient or emergency room treatment) for hyper- or hypoglycemia in subjects with T2DM or for acute exacerbations of heart failure (HF) within the last 3 months.
    6.A history of, or currently diagnosed diabetic gastroparesis or history of bariatric surgery
    7.A confirmed SBP ≥ 180 mm Hg or < 110 mm Hg OR DBP ≥ 110 mm Hg or < 60 mm Hg at screening, based on the mean of the triplicate measurements.
    8.Subjects with symptoms associated with postural hypotension.
    9.Anuria or history of acute renal insufficiency in the past 3 months.
    10.Confirmed diagnosis or history of renal artery stenosis (unilateral or bilateral).
    11.NYHA Class IV HF.
    12.Uncorrected hemodynamically significant primary valvular disease, known obstructive or restrictive cardiomyopathy, or uncontrolled or hemodynamically unstable arrhythmia.
    13.Coronary artery bypass graft, percutaneous intervention (e.g., cardiac, cerebrovascular, aortic), or major surgery including thoracic and cardiac, within 3 months prior to baseline or anticipated need during study participation.
    14.Heart or kidney transplant recipient, or anticipated need for transplant during study participation.
    15.Any of the following cardio-or cerebrovascular events having occurred within 2 months prior to screening:
    a.Any unresolved acute coronary syndrome (ST elevation myocardial infarction, non-ST elevation myocardial infarction, or unstable angina);
    b.Cardiac arrest;
    c.Clinically significant ventricular arrhythmias;
    d.Transient ischemic attack or stroke;
    e.Use of any intravenous cardiac medication.
    16.Body mass index (BMI) ≥ 40 kg/m2.
    17.Serum magnesium < 1.4 mg/dL (< 0.58 mmol/L) at screening based on the local lab results.
    18.Liver enzymes [alanine aminotransferase (ALT), aspartate aminotransferase (AST)] > 3 times upper limit of normal at screening, based on the local lab ALT and AST results.
    19.Active cancer, currently on cancer treatment or history of cancer in the past two years except for non-melanocytic skin cancer that is considered cured.
    20.History of alcoholism or drug/chemical abuse within 1 year of screening.
    21.Use of potassium supplements, bicarbonate or baking soda in the last 7 days prior to screening.
    22.Any of the potassium-altering chronic medications that are stated in the protocol if doses have not been stable for at least 28 days prior to screening or if doses are anticipated to change during study participation
    23.Use of the drugs stated in the protocol.
    24.Use of any investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening.
    25.Prior participation (excluding screen or enrollment failures) in any study assessing the efficacy and safety of patiromer.
    26.Inability to consume the investigational product or, in the opinion of the Investigator, inability to comply with the protocol.
    27.History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery (e.g., large bowel resection).
    28.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 affect the validity of the trial results.
    Part B - Exclusion Criteria
    Subjects who meet ANY of the criteria below at the end of Part A are not eligible for Part B:
    1.Did not complete Part A, the Patiromer Treatment Period; OR
    2.Have a Part A baseline central laboratory serum K+ < 5.5 mEq/L; OR
    3.Have a locally measured serum K+ value at the Part A Week 4 Visit (AW4) outside of the target range, either < 3.8 or ≥ 5.1 mEq/L; OR
    4.On 0 g/d patiromer at the Part A Week 4 Visit (AW4); OR
    5.Not receiving treatment with a RAAS inhibitor medication at the Part A Week 4 Visit (AW4).
    E.5 End points
    E.5.1Primary end point(s)
    Part A: Change in serum potassium
    Part B: Change in serum potassium
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A: Part A baseline to Part A Week 4
    Part B: Part B Week 4, without any modification to either renin angiotensin aldosterone system (RAAS) inhibition therapy or investigational drug (patiromer); or

    At an earlier time point when either the RAAS inhibition therapy or the dose of investigational drug (patiromer) needs to be adjusted to manage a serum potassium (K+) < 3.8 mEq/L or ≥ 5.5 mEq/L.

    E.5.2Secondary end point(s)
    Part A: having Serum K+ level in the target range of 3.8 to <5.1 mEq/L
    and
    Part B: Having K+ more than or equal to 5.1 mEq/L at any time through Week 8
    Part B: Having K+ more than or equal to 5.5 mEq/L at any time through Week 8

    E.5.2.1Timepoint(s) of evaluation of this end point
    Part A: Week 4
    Part B: at any time through Week 8
    Part B: at any time through Week 8
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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 No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 EEA40
    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
    Bulgaria
    Croatia
    Czech Republic
    Denmark
    Georgia
    Hungary
    Italy
    Russian Federation
    Serbia
    Slovenia
    Spain
    Ukraine
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 240
    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)
    No additional treatment with patiromer will be available after participation. Subjects will be referred back to their primary care physician, as needed.
    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 Decision2013-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-06
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