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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2016-002657-38
    Sponsor's Protocol Code Number:RLY5016-207
    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:2016-12-02
    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 number2016-002657-38
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo controlled, Parallel Group Study of Patiromer for the Enablement of Spironolactone Use for Blood Pressure Control in Patients with Resistant Hypertension and Chronic Kidney Disease: Evaluation of Safety and Efficacy (AMBER)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Patiromer alongside Spironolactone to control Blood Pressure in patients with Resistant Hypertension (high blood pressure that does not easily respond to medication) and Chronic Kidney Disease.
    A.3.2Name or abbreviated title of the trial where available
    Spironolactone with Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease
    A.4.1Sponsor's protocol code numberRLY5016-207
    A.5.4Other Identifiers
    Name:US IND NumberNumber:75,615
    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 Limited
    B.5.2Functional name of contact pointMaia Abdushelishvili
    B.5.3 Address:
    B.5.3.1Street Address5, Chavchavadze ave
    B.5.3.2Town/ cityTbilisi
    B.5.3.3Post code0179
    B.5.3.4CountryGeorgia
    B.5.4Telephone number+995322250043
    B.5.5Fax number+995322252043
    B.5.6E-mailmaia.abdushelishvili@worldwide.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 for Oral 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.3.8INN - Proposed INNPatiromer
    D.3.9.1CAS number 1415477-49-4
    D.3.9.2Current sponsor codeRLY5016
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Aldactone
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameAldactone 25 mg
    D.3.4Pharmaceutical form Tablet
    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 INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeAldactone
    D.3.9.3Other descriptive nameSPIRONOLACTONE BP
    D.3.9.4EV Substance CodeSUB174417
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Resistant Hypertension and Chronic Kidney Disease
    E.1.1.1Medical condition in easily understood language
    Hard to treat high blood pressure in patients with Kidney disease
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10020772
    E.1.2Term Hypertension
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if patiromer treatment of CKD subjects receiving spironolactone for the treatment of resistant hypertension will result in:
    • More persistent use of spironolactone through prevention of hyperkalemia
    • Improved blood pressure control through more persistent use of spironolactone
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eligible subjects must meet all the following criteria:
    1. Provide written informed consent prior to participation in the study
    2. Age ≥ 18 years
    3. Taking at least three antihypertensive medications, one of which is a diuretic, for at least 28 days at a stable dose. ACE inhibitors or ARBs should be included among these three antihypertensive medications, unless previously not tolerated or contraindicated.
    4. Uncontrolled hypertension as documented by AOBP SBP 135 to 160 mmHg at each Screening Visit; however, AOBP SBP may be < 135 mmHg at either S2 or S3 Visits
    5. eGFR of 25 – ≤ 45 mL/min/1.73 m2 (mean [calculated by the IWRS] of two values measured at S1 and S3 or 7 to 28 days apart during the Screening/Run-in and calculated using CKD Epidemiology Collaboration [CKD-EPI] formula)
    6. Qualifying local laboratory K+ measurements of 4.3 – 5.1 mEq/L obtained at Visits S1, S3 and S4 (all measurements must be within range)
    7. Females of child-bearing potential must be non-lactating, must have a negative serum pregnancy test at screening, must use a medically acceptable form of birth control from 28 days prior to screening through the study and for 28 days after completion of the study
    E.4Principal exclusion criteria
    Subjects must not meet any of the following criteria:
    1. History of untreated secondary causes of hypertension (other than CKD) including but not limited to Cushing’s syndrome, primary hyperaldosteronism, renal vascular stenosis, or coarctation of the aorta
    2. Inability to measure BP (e.g., the largest sized arm BP cuff is inadequate given the circumference of the subject’s arm)
    3. Noncompliance with antihypertensive medications, in the investigator’s judgment
    4. Change in renal function requiring hospitalization or dialysis within 3 months prior to screening
    5. Renal transplant or anticipated need for renal transplantation during planned study participation
    6. History of malignancy within the previous 12 months except for cured non-melanocytic skin cancer
    7. Recent cardiovascular event (within the last 3 months): myocardial infarction, unstable angina, hospitalization for heart failure, revascularization, or stroke (or transient ischemic attack)
    8. Clinically significant ventricular arrhythmia
    9. Atrial fibrillation with HR > 100 bpm
    10. Previous use of patiromer in a clinical study
    11. Any current use of spironolactone or other mineralocorticoid antagonists (e.g., eplerenone)
    12. Hypersensitivity to patiromer, spironolactone, or any of their components
    13. Use of any of the following permitted potassium-altering chronic medications if doses have not been stable for at least 28 days prior to screening or if doses are anticipated to change during study participation: bronchodilators, theophylline, heparin, and canagiflozin
    14. Use of the following prohibited medications within 7 days prior to Screening: calcium acetate or calcium carbonate supplements (unless for occasional antacid use, at the discretion of the Investigator), digoxin, direct renin inhibitors (e.g., aliskiren), lanthanum carbonate, lithium, sevelamer, quinidine, sodium polystyrene sulfonate or calcium polystyrene sulfonate, colesevelam, colestipol, cholestyramine, drospirenone, potassium supplements, bicarbonate or baking soda (unless for occasional antacid use, at the discretion of the Investigator), triamterene, amiloride, trimethoprim, tacrolimus, cyclosporine, systemic glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (with the exception of low dose aspirin), sympathomimetics
    15. Use of any investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening
    16. History of bowel obstruction, swallowing disorders, clinically significant gastroparesis, severe gastrointestinal disorders or major gastrointestinal surgery (e.g., large bowel resection)
    17. Inability to take the study medications or comply with the protocol, in the opinion of the Investigator
    18. History of alcohol or drug abuse within 1 year of screening
    19. 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, in the opinion of the Investigator
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects remaining on spironolactone at Week 12 will be compared between treatment groups (spironolactone/patiromer vs. spironolactone/placebo) using the Cochran-Mantel-Haenszel test, stratified by baseline serum potassium category (K+ 4.3 – < 4.7 mEq/L or 4.7 – 5.1 mEq/L).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to week 12
    E.5.2Secondary end point(s)
    AOBP SBP change from baseline to Week 12 or last available assessment prior to addition of any new BP medications or changes to any baseline BP medications will be analyzed using analysis of covariance (ANCOVA) methods.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to week 12 or last available assessment before any new BP medication
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3.1Comparator description
    Placebo and Spironolactone
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    France
    Georgia
    Germany
    Hungary
    South Africa
    Ukraine
    United Kingdom
    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
    LPLV
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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: 174
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 116
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 290
    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)
    Expected normal treatment of the condition
    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 Decision2017-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-27
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