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    Summary
    EudraCT Number:2011-000165-12
    Sponsor's Protocol Code Number:RLY5016-205
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-03-29
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2011-000165-12
    A.3Full title of the trial
    A Multicenter, Randomized, Open-Label, Dose Ranging Study to Evaluate the Efficacy and Safety of RLY5016 in the Treatment of Hyperkalemia in Patients with Hypertension and Diabetic Nephropathy Receiving ACEI and/or ARB Drugs, with or without Spironolactone
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to test if RLY5016 is safe and can lower high blood potassium levels in patients with high blood pressure and kidney disease due to diabetes who are also taking standard medications for their disease.
    A.3.2Name or abbreviated title of the trial where available
    AMETHYST-DN
    A.4.1Sponsor's protocol code numberRLY5016-205
    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 pointKaren Hill
    B.5.3 Address:
    B.5.3.1Street AddressIsaac Newton Centre, Nottingham Science Park
    B.5.3.2Town/ cityNottingham
    B.5.3.3Post codeNG7 2RH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44115956 7711
    B.5.5Fax number+44115922 0960
    B.5.6E-mailkaren.hill@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 nameRLY5016 powder for suspension
    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.3.9.1CAS number 1208912-84-8
    D.3.9.2Current sponsor codeRLY5016S
    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 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
    Hyperkalemia in Patients with Hypertension and Diabetic Nephropathy
    E.1.1.1Medical condition in easily understood language
    Higher-than-normal blood potassium in patients with high blood pressure and kidney disease due to diabetes.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10020772
    E.1.2Term Hypertension
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10020647
    E.1.2Term Hyperkalemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10061835
    E.1.2Term Diabetic nephropathy
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine the optimal starting dose of RLY5016 in treating hyperkalemia in patients with hypertension and diabetic nephropathy receiving ACEI and/or ARB drugs, with or without spironolactone
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    •To determine the efficacy of RLY5016 in treating hyperkalemia in patients with hypertension and diabetic nephropathy receiving ACEI and/or ARB drugs, with or without spironolactone
    •To determine the safety of RLY5016 in treating hyperkalemia in patients with hypertension and diabetic nephropathy receiving ACEI and/or ARB drugs, with or without spironolactone
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet ALL of the following inclusion criteria:
    1. Age 30 – 80 years old at screening
    2. Type 2 diabetes mellitus (T2DM) diagnosed after age 30 which has been treated with oral medications or
    insulin for at least one year prior to screening
    3. Chronic kidney disease (estimated GFR 15 – < 60 mL/min/1.73m2 at screening based on central laboratory serum creatinine measurement)
    4. Urine ACR ≥ 100 mg/g at screening (S1) AND average urine ACR ≥ 100 mg/g at the beginning of run-in
    period (R0) based on up to 3 ACR values obtained starting at S1 and ending at the R0 Visit
    5. Local laboratory serum K+ value of 4.5 – 5.0 mEq/L at screening (S1) AND local laboratory serum K+ value > 5.0 – < 6.0 mEq/L at randomization to RLY5016 (Baseline, T0 Visit)
    6. Must be receiving an ACEI and/or ARB for at least 28 days prior to screening
    7. Average systolic blood pressure ≥ 140 – < 180 mmHg OR average diastolic blood pressure ≥ 90 – < 110 mmHg (sitting) at screening
    8. 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 RLY5016 administration, during the study, and for one month after study completion
    9. Provide their written informed consent prior to participation in the study
    E.4Principal exclusion criteria
    Patients must NOT meet ANY of the following exclusion criteria:
    1. Type 1 diabetes mellitus
    2. Hemoglobin A1c > 12% at screening or emergency treatment for T2DM within the last 3 months
    3. Diabetic gastroparesis
    4. Non-diabetic chronic kidney disease
    5. History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery (e.g., cholectomy)
    6. Current diagnosis of NYHA Class III or IV heart failure
    7. Body mass index (BMI) ≥ 40 kg/m2
    8. Any of the following events having occurred within 2 months prior to screening: unstable angina as judged by the Investigator, unresolved acute coronary syndrome, cardiac arrest or clinically significant ventricular arrhythmias, transient ischemic attack or stroke, use of any intravenous cardiac medication
    9. Prior kidney transplant, or anticipated need for transplant during study participation
    10. Active cancer, currently on cancer treatment or history of cancer in the past two years except for nonmelanocytic skin cancer which is considered cured
    11. History of alcoholism or drug/chemical abuse within 1 year
    12. Liver enzymes [alanine aminotransferase (ALT), aspartate aminotransferase (AST)] > 3 times upper limit of normal
    13. Loop and thiazide diuretics or other antihypertensive medications (calcium channel blocker, beta-blocker, alpha-blocker, or centrally acting agent) that have not been stable for at least 28 days prior to screening or not anticipated to remain stable during study participation
    14. Current use of polymer-based drugs (e.g., sevelamer, sodium polystyrene sulfonate, colesevelam, colestipol, cholestyramine), phosphate binders (e.g., lanthanum carbonate), or other potassium binders, or their anticipated need during study participation
    15. Current use of lithium
    16. Use of potassium sparing medications, including aldosterone antagonists (e.g., spironolactone), potassium supplements, bicarbonate or baking soda in the last 7 days prior to screening
    17. Use of any investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening
    18. Patients who have taken RLY5016 previously
    19. Inability to consume the investigational product, or, in the opinion of the Investigator, inability to comply with the protocol
    20. 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 patient or affect the validity of the trial results
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in serum potassium from baseline to week 4 or prior to the initiation of RLY5016 dose titration (if occurs before week 4)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 4 or earlier if RLY5016 dose titration is initiated before Week 4
    E.5.2Secondary end point(s)
    1. Mean change in serum potassium from baseline to week 8 or prior to the initiation of RLY5016 dose titration
    2. Proportion of patients maintaining the starting RLY5016 dose at week 4 and 8
    3. Mean change in serum potassium from baseline to post-baseline visits
    4. Proportion of patients requiring RLY5016 titration
    5. Mean time to first RLY5016 titration
    6. Mean number of RLY5016 titrations
    7. Proportion of patients who maintain serum potassium (K+) in the range of 3.5 – 5.5 mEq/L by visit and during the entire study treatment period
    8. Proportion of patients who maintain serum K+ in the range of 4.0 – 5.0 mEq/L by visit and during the entire study treatment period
    9. Proportion of patients who discontinue from the study due to high serum potassium withdrawal criteria
    10. Mean change in blood pressure from screening to week 4 and 8
    11. Mean change in urine albumin to creatinine ratio (ACR) from screening to week 4 and 8
    12. Proportion of patients with ≥ 35% reduction in urine ACR from screening to week 4 and 8
    13. Proportion of patients with urine ACR ≥ 500 mg/g at screening who achieve ACR < 500 mg/g at week 4 and 8
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 8 or earlier if RLY5016 titration is initiated before Week 8
    2. Weeks 4 and 8
    3. Weeks 1-8 and 7 days following final treatment visit
    4. Through Week 8
    5. Through Week 8
    6. Week 8
    7. Weeks 1-8
    8. Weeks 1-8
    9. Through Week 8
    10. Weeks 4 and 8
    11. Weeks 4 and 8
    12. Weeks 4 and 8
    13. Weeks 4 and 8
    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 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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    All Patients randomised to starting dose of RLY5016
    E.8.2.4Number of treatment arms in the trial5
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Austria
    Croatia
    Georgia
    Germany
    Hungary
    Serbia
    Slovenia
    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
    As in protocol
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 100
    F.4.2.2In the whole clinical trial 150
    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)
    As in the current protocol
    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 Decision2011-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-17
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