Evaluation of Patiromer in Heart Failure Patients (PEARL-HF)
10. mai 2021 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
120
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Barnaul, Den russiske føderasjonen, 656099
- Investigator Site 409
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Kemerovo, Den russiske føderasjonen, 650002
- Investigator Site 407
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Moscow, Den russiske føderasjonen, 111020
- Investigator Site 406
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Moscow, Den russiske føderasjonen, 111539
- Investigator Site 402
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Moscow, Den russiske føderasjonen, 129301
- Investigator Site 403
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St Petersburg, Den russiske føderasjonen, 197341
- Investigator Site 404
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St Petersburg, Den russiske føderasjonen, 198205
- Investigator Site 412
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St Petersburg, Den russiske føderasjonen, 199106
- Investigator Site 405
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Florida
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Miami, Florida, Forente stater, 33176
- Investigator Site 029
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Port Charlotte, Florida, Forente stater, 33952
- Investigator Site 031
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Illinois
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Peoria, Illinois, Forente stater, 61606
- Investigator Site 009
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55417
- Investigator Site 018
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New York
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Buffalo, New York, Forente stater, 14215
- Investigator Site 020
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Northport, New York, Forente stater, 11768
- Investigator Site 005
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Ohio
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Columbus, Ohio, Forente stater, 43210
- Investigator Site 022
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Texas
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Dallas, Texas, Forente stater, 75216
- Investigator Site 001
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Utah
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Salt Lake City, Utah, Forente stater, 84124
- Investigator Site 019
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Tbilisi, Georgia, 0102
- Investigator Site 605
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Tbilisi, Georgia, 0159
- Investigator Site 602
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Tbilisi, Georgia, 0164
- Investigator Site 604
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Tbilisi, Georgia, 0179
- Investigator Site 603
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Warsaw, Polen, 02637
- Investigator Site 305
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Brno, Tsjekkia, 62500
- Investigator site 102
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Prague, Tsjekkia, 12008
- Investigator site 104
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Prague, Tsjekkia, 14021
- Investigator site 103
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Gottingen, Tyskland, 37075
- Investigator site 201
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Heidelberg, Tyskland, 69120
- Investigator site 202
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Dnipropetrovsk, Ukraina, 49023
- Investigator Site 507
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Kharkiv, Ukraina, 61018
- Investigator Site 502
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Kharkiv, Ukraina, 61176
- Investigator Site 509
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Kiev, Ukraina, 03680
- Investigator Site 504
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Kiev, Ukraina, 03680
- Investigator Site 506
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Kiev, Ukraina, 04114
- Investigator Site 501
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Placebo komparator: placebo
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placebo
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Aktiv komparator: patiromer
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Aktivt undersøkelsesmiddel
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period.
Tidsramme: Baseline and Day 28
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Baseline and Day 28
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of Participants With a Serum Potassium Level During the 28-day Treatment Period That Was > 5.5 mEq/L.
Tidsramme: 28 Days
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Analysis based on central laboratory data.
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28 Days
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Proportion of Participants Discontinuing the Study Due to Serum Potassium Elevation (Serum K+ > 5.5 mEq/L).
Tidsramme: 28 Days
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Analysis based on local laboratory data.
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28 Days
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Proportion of Participants Whose Spironolactone Dose Was Increased.
Tidsramme: 28 Days
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28 Days
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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
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Baseline and Day 28
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Time to First Elevated Serum K+ > 5.5 mEq/L.
Tidsramme: 28 Days
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28 Days
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Pitt B, Anker SD, Bushinsky DA, Kitzman DW, Zannad F, Huang IZ; PEARL-HF Investigators. Evaluation of the efficacy and safety of RLY5016, a polymeric potassium binder, in a double-blind, placebo-controlled study in patients with chronic heart failure (the PEARL-HF) trial. Eur Heart J. 2011 Apr;32(7):820-8. doi: 10.1093/eurheartj/ehq502. Epub 2011 Jan 5.
- Natale P, Palmer SC, Ruospo M, Saglimbene VM, Strippoli GF. Potassium binders for chronic hyperkalaemia in people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Jun 26;6(6):CD013165. doi: 10.1002/14651858.CD013165.pub2.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2009
Primær fullføring (Faktiske)
1. november 2009
Studiet fullført (Faktiske)
1. desember 2009
Datoer for studieregistrering
Først innsendt
23. mars 2009
Først innsendt som oppfylte QC-kriteriene
24. mars 2009
Først lagt ut (Anslag)
25. mars 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. juni 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. mai 2021
Sist bekreftet
1. mai 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RLY5016-202
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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