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Evaluation of Patiromer in Heart Failure Patients (PEARL-HF)

10. maj 2021 opdateret af: Relypsa, Inc.

A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Study to Evaluate the Effects of Patiromer in Heart Failure Patients

The purpose of this study was to assess the effects of patiromer on serum potassium participants with heart failure. This study also assessed the safety and tolerability of patiromer in participants with heart failure.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This was a double-blind, randomized, placebo-controlled, parallel-group, multiple-dose study in congestive heart failure participants. Depending on the outcome from the initial cohort of 100 participants (Part 1), a second cohort of 170 participants could have been enrolled (Part 2). Based on the results of Part 1 of the study, Part 2 was not conducted.

Participants were randomly assigned to and received patiromer (30 g/day) or placebo for up to 28 days. All participants also received spironolactone; the initial spironolactone dose was 25 mg daily and was increased to 50 mg daily for participants who had a serum potassium ≤ 5.1 mEq/L on treatment Day 14. Study visits occurred on treatment Days 3, 7, 14, 17, 21 and 28. A safety follow-up contact was made 7 days after administration of last dose of study drug.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

120

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Den Russiske Føderation
      • Barnaul, Den Russiske Føderation, 656099
        • Investigator Site 409
      • Kemerovo, Den Russiske Føderation, 650002
        • Investigator Site 407
      • Moscow, Den Russiske Føderation, 111020
        • Investigator Site 406
      • Moscow, Den Russiske Føderation, 111539
        • Investigator Site 402
      • Moscow, Den Russiske Føderation, 129301
        • Investigator Site 403
      • St Petersburg, Den Russiske Føderation, 197341
        • Investigator Site 404
      • St Petersburg, Den Russiske Føderation, 198205
        • Investigator Site 412
      • St Petersburg, Den Russiske Føderation, 199106
        • Investigator Site 405
  • Forenede Stater
    • Florida
      • Miami, Florida, Forenede Stater, 33176
        • Investigator Site 029
      • Port Charlotte, Florida, Forenede Stater, 33952
        • Investigator Site 031
    • Illinois
      • Peoria, Illinois, Forenede Stater, 61606
        • Investigator Site 009
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55417
        • Investigator Site 018
    • New York
      • Buffalo, New York, Forenede Stater, 14215
        • Investigator Site 020
      • Northport, New York, Forenede Stater, 11768
        • Investigator Site 005
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Investigator Site 022
    • Texas
      • Dallas, Texas, Forenede Stater, 75216
        • Investigator Site 001
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84124
        • Investigator Site 019
  • Georgien
      • Tbilisi, Georgien, 0102
        • Investigator Site 605
      • Tbilisi, Georgien, 0159
        • Investigator Site 602
      • Tbilisi, Georgien, 0164
        • Investigator Site 604
      • Tbilisi, Georgien, 0179
        • Investigator Site 603
  • Polen
      • Warsaw, Polen, 02637
        • Investigator Site 305
  • Tjekkiet
      • Brno, Tjekkiet, 62500
        • Investigator site 102
      • Prague, Tjekkiet, 12008
        • Investigator site 104
      • Prague, Tjekkiet, 14021
        • Investigator site 103
  • Tyskland
      • Gottingen, Tyskland, 37075
        • Investigator site 201
      • Heidelberg, Tyskland, 69120
        • Investigator site 202
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49023
        • Investigator Site 507
      • Kharkiv, Ukraine, 61018
        • Investigator Site 502
      • Kharkiv, Ukraine, 61176
        • Investigator Site 509
      • Kiev, Ukraine, 03680
        • Investigator Site 504
      • Kiev, Ukraine, 03680
        • Investigator Site 506
      • Kiev, Ukraine, 04114
        • Investigator Site 501

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Participants with chronic heart failure clinically indicated to receive spironolactone therapy, aged 18 years or older with serum potassium level of 4.3 - 5.1 mEq/L at screening and baseline, AND (1) chronic kidney disease (GFR < 60 mL/min) OR (2) documented history of hyperkalemia within the last 6 months
  • 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
  • Male participants 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
  • Must sign informed consent document

Exclusion Criteria:

  • History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery
  • Uncorrected hemodynamically significant primary valvular disease, known obstructive or restrictive cardiomyopathy, uncontrolled or hemodynamically unstable arrhythmia
  • 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
  • Heart transplant recipient, or anticipated need for transplant during study participation
  • 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
  • Current dialysis participant, or anticipated need for dialysis during study participation
  • Prior kidney transplant, or anticipated need for transplant during study participation
  • Metastatic, late-stage or end-stage cancer with < 12 months life expectancy
  • History of alcoholism or drug/chemical abuse within 1 year
  • QTcB interval > 500 msec (Bazett's correction formula)
  • Sustained systolic blood pressure > 170 or < 90 mmHg
  • Liver enzymes (ALT, AST) > 3 times upper limit of normal
  • Use of oral cardiac medications (including loop and thiazide diuretics) that have not been stable for at least 21 days prior to baseline and are not anticipated to remain stable during study participation
  • Use of any IV cardiac medications within 21 days prior to baseline, or their anticipated need during study participation.
  • Current use of polymer-based drugs (e.g. Renagel, Kayexalate, Welchol, Colestid), other phosphate binders or potassium binders, calcium supplements, antacids (eg TUMS, Maalox), or their anticipated need during study participation
  • Use of aldosterone antagonist in the last 30 days prior to baseline, unless was discontinued due to hyperkalemia
  • Use of potassium sparing medication and/or potassium supplements in the last 30 days prior to baseline
  • Use of any investigational medication, 30 days or 5 half-lives whichever is longer, prior to baseline
  • Participants who have taken investigational product in this study, or a previous patiromer study
  • Inability to consume the study medication, or, in the opinion of the Investigator, inability to comply with the protocol
  • 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 participant or affect the validity of the trial results

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: placebo
Medicin: placebo
placebo
Aktiv komparator: patiromer
Medicin: patiromer
Aktivt forsøgslægemiddel
Andre navne:
  • RLY5016
  • Veltassa

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period.
Tidsramme: Baseline and Day 28
Baseline and Day 28

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Participants With a Serum Potassium Level During the 28-day Treatment Period That Was > 5.5 mEq/L.
Tidsramme: 28 Days
Analysis based on central laboratory data.
28 Days
Proportion of Participants Discontinuing the Study Due to Serum Potassium Elevation (Serum K+ > 5.5 mEq/L).
Tidsramme: 28 Days
Analysis based on local laboratory data.
28 Days
Proportion of Participants Whose Spironolactone Dose Was Increased.
Tidsramme: 28 Days
28 Days
Proportion of Participants With an Increase in Serum Potassium Level From Baseline to the End of the 28-day Treatment Period That Was ≥ 0.5 mEq/L
Tidsramme: Baseline and Day 28
Baseline and Day 28
Time to First Elevated Serum K+ > 5.5 mEq/L.
Tidsramme: 28 Days
28 Days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Relypsa, Inc.

Samarbejdspartnere

Medpace, Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2009

Primær færdiggørelse (Faktiske)

1. november 2009

Studieafslutning (Faktiske)

1. december 2009

Datoer for studieregistrering

Først indsendt

23. marts 2009

Først indsendt, der opfyldte QC-kriterier

24. marts 2009

Først opslået (Skøn)

25. marts 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. maj 2021

Sidst verificeret

1. maj 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RLY5016-202

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Kliniske forsøg med placebo

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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CROs in Albania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner