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    Summary
    EudraCT Number:2010-018838-45
    Sponsor's Protocol Code Number:RLY5016–204
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-24
    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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2010-018838-45
    A.3Full title of the trial
    A Multicenter, Open-Label, Single-Arm Study to Evaluate a Titration Regimen for RLY5016 in Heart Failure Patients with Chronic Kidney Disease
    A.3.2Name or abbreviated title of the trial where available
    Evaluation of RLY5016 Titration in Heart Failure Patients with Chronic Kidney Disease
    A.4.1Sponsor's protocol code numberRLY5016–204
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.2.1.1.1Trade name N/A
    D.2.1.1.2Name of the Marketing Authorisation holderN/A
    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 nameRLY5016
    D.3.2Product code RLY5016
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeRLY5016
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typePolymer-based synthetic product
    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
    Heart failure with Chronic kidney disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10008908
    E.1.2Term Chronic heart failure
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the feasibility of individualized titration of RLY5016 according to
    serum potassium.
    E.2.2Secondary objectives of the trial
    To assess the effects of RLY5016 on serum potassium in heart failure patients
    with chronic kidney disease

    To assess the safety and tolerability of RLY5016 in heart failure patients with
    chronic kidney disease
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Chronic heart failure clinically indicated to receive spironolactone therapy
    2. Age 18 years or older
    3. Local lab serum potassium values of 4.3 – 5.1 mEq/L at screening and
    baseline
    4. Chronic kidney disease (estimated GFR < 60 mL/min/1.73m2 at screening
    based on central lab creatinine measurement)
    5. On at least one of the following heart failure therapies: angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blocker (ARB), or beta blocker (BB)
    6. 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 study drug
    administration, during the study, and for one month after study completion
    7. Male patients and/or their female partners of child-bearing potential must
    use a highly effective form of contraception during the study and for
    3 months after study completion
    8. Provide their written informed consent prior to participation in the study
    E.4Principal exclusion criteria
    1. History of bowel obstruction, swallowing disorders, severe gastrointestinal
    disorders or major gastrointestinal surgery
    2. Uncorrected primary severe valvular disease, known obstructive or
    restrictive cardiomyopathy, uncontrolled or hemodynamically unstable
    arrhythmia
    3. 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
    4. Heart transplant recipient, or anticipated need for transplant during study
    participation
    5. Any of the following events having occurred within 2 months prior to
    baseline: unstable angina as judged by the Investigator, unresolved acute
    coronary syndrome, transient ischemic attack or stroke
    6. Current dialysis patient, or anticipated need for dialysis during study
    participation
    7. Prior kidney transplant, or anticipated need for transplant during study
    participation
    8. Metastatic, late-stage or end-stage cancer with < 12 months life
    expectancy or at risk for tumor lysis syndrome
    9. History of alcoholism or drug/chemical abuse within 1 year
    10. Sustained systolic blood pressure > 180 or < 90 mmHg
    11. Liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST)) > 3 times upper limit of normal
    12. Loop and thiazide diuretics have not been stable for at least 21 days prior
    to baseline or not anticipated to remain stable during study participation
    13. Use of any intravenous cardiac medications within 21 days prior to
    baseline, or their anticipated need during study participation
    14. Current use of polymer-based drugs (e.g., sevelamer, sodium polystyrene
    sulfonate, colesevelam, colestipol), phosphate binders (e.g., lanthanum
    carbonate), or other potassium binders, or their anticipated need during
    study participation
    15. Use of potassium sparing medications including aldosterone antagonists
    or potassium supplements in the last 21 days prior to baseline
    16. Use of any investigational medication within 30 days or 5 half-lives
    whichever is longer, prior to baseline
    17. Patients who have taken investigational product in this study, or a
    previous RLY5016 study
    18. Inability to consume the study medication, or, in the opinion of the
    Investigator, inability to comply with the protocol
    19. In the opinion of the Investigator, any medical condition, uncontrolled
    systemic disease, serious intercurrent illness, or extenuating circumstance
    occurring or persisting, within 30 days prior to baseline, that would
    significantly decrease study compliance or jeopardize the safety of the
    patient or affect the validity of the trial results
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with serum potassium in the normal range of 3.5 – 5.5 mEq/L at the end of the study.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    to evaluate the feasibility of individualized titration of RLY5016
    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 No
    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 concerned7
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA7
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months6
    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 months6
    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.1.3Elderly (>=65 years) Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 60
    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 Decision2010-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-11-05
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