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    Summary
    EudraCT Number:2017-003555-35
    Sponsor's Protocol Code Number:PAT-DEU-402
    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:2017-10-04
    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 number2017-003555-35
    A.3Full title of the trial
    A Multicentre, Randomised, Open-label, Parallel-Group Pilot Study to Evaluate the Efficacy of Patiromer in Optimising Mineralocorticoid Receptor Antagonist Therapy in Heart Failure Subjects with Hyperkalaemia
    Eine multizentrische, randomisierte, offene, Parallelgruppenpilotstudie zur Beurteilung der Wirksamkeit von Patiromer bei der Optimierung der Therapie mit Mineralokortikoid-Rezeptor-Antagonisten bei Herzinsuffizienz-Patienten mit Hyperkaliämie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial evaluating the efficacy of Patiromer in optimizing the therapy with mineralocorticoid receptor antagonists in heart failure patients who also suffer from hyperkalaemia
    A.3.2Name or abbreviated title of the trial where available
    CONTINUE-HF
    A.4.1Sponsor's protocol code numberPAT-DEU-402
    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 SponsorFresenius Medical Care Nephrologica Deutschland GmbH
    B.1.3.4CountryGermany
    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 supportFresenius Medical Care Nephrologica Deutschland GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWinicker Norimed GmbH Medizinische Forschung
    B.5.2Functional name of contact pointContract Research Organisation
    B.5.3 Address:
    B.5.3.1Street AddressDeutschherrnstr. 15-19
    B.5.3.2Town/ cityNuremberg
    B.5.3.3Post code90429
    B.5.3.4CountryGermany
    B.5.4Telephone number+49911926808776
    B.5.5Fax number+49911926808840
    B.5.6E-mailcontinue-hf-ph4@winicker-norimed.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 AuthorisationGermany
    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.3.4Pharmaceutical 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 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 typeequal
    D.3.10.3Concentration number8.4
    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
    Heart Failure with reduced ejection fraction (HFrEF) subjects with hyperkalaemia
    E.1.1.1Medical condition in easily understood language
    Increased potassium level in the blood of patients with heart failure.
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10020646
    E.1.2Term Hyperkalaemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition 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 evaluate the efficacy of patiromer in optimising MRA therapy in hyperkalaemic HFrEF subjects.
    E.2.2Secondary objectives of the trial
    Secondary objectives according to protocol:
    1. To assess clinically relevant outcome of optimised MRA therapy in HFrEF subjects
    2. To generate initial (pilot) evidence to support potential future trial design
    Additional objective according to protocol:
    3. To evaluate the safety of patiromer in hyperkalaemic HFrEF subjects
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects with HFrEF and left ventricular ejection fraction (LVEF) < 40%
    2. New York Heart Association (NYHA) class II or III
    3. N/A
    4. Male and female adults with age ≥ 18 years
    5. Females of child-bearing potential must be non-lactating, must have a negative pregnancy test at Visit S1 (urine) and Visit S2 (serum). Subject must agree to use a highly effective method of birth control during the study and for 1 month after the last dose of study medication.
    6. Subjects with hyperkalaemia (serum K+ ≥ 5.1 mmol/L) that limits ability to maintain or to increase eplerenone or spironolactone dose
    7. Subjects on MRA therapy in accordance with the respective product label
    8. Subjects on stable guideline recommended HF therapy, i.e., on one or more HF therapies (e.g., angiotensin-converting enzyme inhibitor [ACEi], angiotensin receptor blocker [ARB], angiotensin receptor neprilysin inhibitor [ARNi], beta blocker [BB], diuretic) that are anticipated to remain stable during study participation with the exception of the diuretic
    9. Subject has provided the appropriate written informed consent. Subject must provide written informed consent before any study-specific procedures are performed including screening procedures
    E.4Principal exclusion criteria
    1. History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery
    2. Uncorrected haemodynamically significant primary valvular disease, known obstructive or restrictive cardiomyopathy, uncontrolled or haemodynamically 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 3 months prior to baseline: unstable angina as judged by the Investigator, unresolved acute coronary syndrome, transient ischemic attack or stroke
    6. Current dialysis subject, or anticipated need for dialysis during study participation
    7. Prior kidney transplant, or anticipated need for transplant during study participation
    8. Cancer with < 12 months life expectancy
    9. N/A
    10. Sustained, as judged by the Investigator, systolic blood pressure (SBP) > 170 or < 90 mmHg
    11. Liver enzymes (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) > 5 times upper limit of normal (ULN)
    12. Subjects with hypercalcaemia, as judged by the Investigator
    13. Use of intravenous (IV) cardiac medications for treatment of decompensated HF within 21 days prior to baseline, or their anticipated need during study participation
    14. Use of potassium sparing medication or potassium supplements in the last 7 days prior to baseline
    15. Subject is taking any prohibited medication(s) within 7 days prior to baseline or anticipated to be needed during study participation
    16. Subject has known hypersensitivity to the active substance of the study product, rare hereditary problems of fructose intolerance or an intolerance to xanthan gum
    17. Subject has previously entered this study or another patiromer study
    18. Subject is currently enrolled in or has completed any other investigational device or drug study < 21 days or 5 half-lives (whichever is greater) prior to screening, or is receiving other investigational agent(s)
    19. Subject has a history of drug or alcohol abuse within 2 years prior to screening
    20. Subject has a significant medical condition(s), anticipated need for major surgery during the study, or any other kind of disorder that may be associated with increased risk to the subject, or may interfere with study assessments, outcomes, or the ability to provide written informed consent or comply with study procedures, in the Investigator’s opinion
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects maintaining or achieving the guideline-recommended [Ponikowski, 2016] and evidence-based target dose of 50 mg/day eplerenone or spironolactone (see section 7.6) in the patiromer group versus the SoC group at Visit D42.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 42 +/- 7 days (Visit 8)
    E.5.2Secondary end point(s)
    Secondary endpoints according to protocol:
    1) Patient global assessment (PGA)
    2) Change in Quality of Life (QoL) European Quality of Life five dimensions questionnaire-five level (EQ-5D-5L)
    3) Change in NYHA class and functional capacity
    4) Change in eplerenone or spironolactone dosage from baseline over time
    E.5.2.1Timepoint(s) of evaluation of this end point
    1), 2) , 3): Day 21 +/- 3 days (Visit 6) and Day 42 +/- 7 days (Visit 8)

    4) : At each visit from Visit 3 (Day 3 +/- 1 day) unto Visit 9 (follow-up visit taking place 7 - 14 days after Visit 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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of Care treatment: diet, renal potassium elimination, and reducing potassium sparing drugs
    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 concerned28
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    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 months19
    E.8.9.1In the Member State concerned 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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state100
    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)
    It is at the discretion of the Investigator to continue treatment with patiromer after End-of-study/Early Termination and to adjust dose accordingly.
    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 Decision2017-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-31
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