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KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial) (COMPASS)

10. března 2021 aktualizováno: Keryx Biopharmaceuticals

Study of KRX-0502 (Ferric Citrate) Dose Regimens in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and Iron-Deficiency Anemia

The objectives of this study are to assess the long-term efficacy and safety of different dose regimens of KRX-0502 in the treatment of iron deficiency anemia (IDA) in adult subjects with non-dialysis dependent chronic kidney disease (CKD).

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

This is a Phase 4, 48-week, randomized, open-label, multicenter clinical study comprised of 2 periods: a 24-week Dose Titration Period, followed by a 24-week Dose Maintenance Period. The study will consist of 12 scheduled clinic visits over a period of 48 weeks and additional visits as needed.

Typ studie

Intervenční

Zápis (Aktuální)

206

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Arizona
      • Phoenix, Arizona, Spojené státy, 85032
        • Arizona Kidney Disease and Hypertension center: AKDHC Medical Research Services, LLC
    • California
      • Chula Vista, California, Spojené státy, 91910
        • California Institute of Renal Research
      • El Centro, California, Spojené státy, 92243
        • California Institute of Renal Research
      • Poway, California, Spojené státy, 92064
        • California Institute of Renal Research
    • Colorado
      • Denver, Colorado, Spojené státy, 80230
        • Denver Nephrologists, P.C.
    • Florida
      • Miami, Florida, Spojené státy, 33143
        • Miami Kidney Group
      • Miami, Florida, Spojené státy, 33150
        • Kidney and Hypertension Specialists of Miami, P.A.
    • Georgia
      • Augusta, Georgia, Spojené státy, 30904
        • Southeastern Clinical Research Institute, LLC
      • Columbus, Georgia, Spojené státy, 31904
        • Renal Associates, LLC
    • Illinois
      • Chicago, Illinois, Spojené státy, 60643
        • Research by Design, LLC
    • Mississippi
      • Gulfport, Mississippi, Spojené státy, 39501
        • South Mississippi Medical Research, LLC
    • Missouri
      • Kansas City, Missouri, Spojené státy, 64111
        • Clinical Research Consultants
    • Nevada
      • Reno, Nevada, Spojené státy, 89511
        • Sierra Nevada Nephrology Consultants
    • New Jersey
      • Eatontown, New Jersey, Spojené státy, 07724
        • Hypertension and Nephrology Association
    • New York
      • Great Neck, New York, Spojené státy, 11021
        • Division of Kidney/HTN Research
    • North Carolina
      • Asheville, North Carolina, Spojené státy, 28801
        • Mountain Kidney & Hypertension Associates
      • Charlotte, North Carolina, Spojené státy, 28207
        • Metrolina Nephrology Associates, PA
      • Greenville, North Carolina, Spojené státy, 27834
        • Eastern Nephrology Associates
      • Jacksonville, North Carolina, Spojené státy, 28546
        • Southeastern Nephrology Associates
      • New Bern, North Carolina, Spojené státy, 28562
        • Eastern Nephrology Associates
      • Wilmington, North Carolina, Spojené státy, 28401
        • Southeastern Nephrology
    • South Carolina
      • Columbia, South Carolina, Spojené státy, 29203
        • Columbia Nephrology Associates, PA
      • Orangeburg, South Carolina, Spojené státy, 29118
        • South Carolina Nephrology & Hypertension Center, Inc
    • Tennessee
      • Nashville, Tennessee, Spojené státy, 37205
        • Nephrology Associates, P.C.
    • Texas
      • Austin, Texas, Spojené státy, 78758
        • Research Management, Inc.
      • Austin, Texas, Spojené státy, 78751
        • Research Management, Inc.
      • Lufkin, Texas, Spojené státy, 75904
        • P & I Clinical Research, LLC
      • San Antonio, Texas, Spojené státy, 78212
        • Clinical Advancement Center, PLLC

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Estimated glomerular filtration rate ≥20 mL/min and <60 mL/min
  • Hgb ≥8.5 g/dL and ≤11.5 g/dL
  • Serum ferritin ≤500 ng/mL and transferrin saturation (TSAT) ≤25%
  • Serum intact parathyroid hormone ≤600 pg/mL

Exclusion Criteria:

  • Serum phosphate <3.0 mg/dL
  • Intravenous (IV) iron administered within 4 weeks prior to Screening
  • Erythropoiesis-stimulating agents (ESA) administered within 4 weeks prior to Screening
  • Blood transfusion within 4 weeks prior to Screening

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Group 1
KRX-0502 1 tablet thrice daily (TID) with meals
Lék: KRX-0502
Oral ferric citrate with meals
Ostatní jména:
  • citrát železitý
Experimentální: Group 2
KRX-0502 2 tablets twice daily (BID) with the largest 2 daily meals
Lék: KRX-0502
Oral ferric citrate with meals
Ostatní jména:
  • citrát železitý

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline in Hemoglobin (Hgb) at Week 24
Časové okno: Baseline; Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from a mixed model of repeated measures (MMRM), including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Baseline; Week 24

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline in Hgb at Week 48
Časové okno: Baseline; Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Baseline; Week 48
Time From Randomization to the First Increase From Baseline Hgb of at Least 0.5 Grams Per Deciliter (g/dL) During the Dose Titration Period
Časové okno: from Randomization to Week 24
The Kaplan-Meier estimator of the survival function of time from randomization to the first increase from Baseline Hgb of at least 0.5 g/dL for each of the two starting dose treatment groups were obtained.
from Randomization to Week 24
Change From Baseline in Transferrin Saturation (TSAT) at Week 24
Časové okno: Baseline; Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Baseline; Week 24
Change From Baseline in TSAT at Week 48
Časové okno: Baseline; Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Baseline; Week 48
Change From Baseline in Ferritin at Week 24
Časové okno: Baseline; Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Baseline; Week 24
Change From Baseline in Ferritin at Week 48
Časové okno: Baseline; Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Baseline; Week 48
Change From Baseline in Serum Phosphate at Week 24
Časové okno: Baseline; up to Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Baseline; up to Week 24
Change From Baseline in Serum Phosphate at Week 48
Časové okno: Baseline; Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Baseline; Week 48
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
Časové okno: Baseline; Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Baseline; Week 24
Change From Baseline in eGFR at Week 48
Časové okno: Baseline; Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Baseline; Week 48
Change From Baseline in Bicarbonate at Week 24
Časové okno: Baseline; Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Baseline; Week 24
Change From Baseline in Bicarbonate at Week 48
Časové okno: Baseline; Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates are from an MMRM, including an intercept term and covariates for randomized treatment, visit, treatment by visit interaction, Baseline value, and Baseline value by visit interaction. The Kenward-Roger method was used along with an unstructured covariance matrix.
Baseline; Week 48
Change From Baseline in Intact Parathyroid Hormone (iPTH) at Week 24
Časové okno: Baseline; Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using a common slope analysis of covariance (ANCOVA) model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, and a random error term.
Baseline; Week 24
Change From Baseline in iPTH at Week 48
Časové okno: Baseline; Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.
Baseline; Week 48
Change From Baseline in C-terminal Fibroblast Growth Factor 23 (FGF23) at Week 24
Časové okno: Baseline; Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.
Baseline; Week 24
Change From Baseline in C-terminal FGF23 at Week 48
Časové okno: Baseline; Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.
Baseline; Week 48
Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 24
Časové okno: Baseline; Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using a common slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, and a random error term.
Baseline; Week 24
Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 48
Časové okno: Baseline; Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Estimates obtained using an uncommon slope ANCOVA model which includes the Baseline laboratory parameter as a covariate, randomized treatment group, randomized treatment group by Baseline interaction, and a random error term.
Baseline; Week 48
Change From Baseline Scores for the Work Productivity and Activity Impairment (WPAI) Questionnaire Adapted for Anemia Associated With Chronic Kidney Disease (CKD) at Week 24: Work-associated Measures
Časové okno: Baseline; Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.
Baseline; Week 24
Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Work-associated Measures
Časové okno: Baseline; Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.
Baseline; Week 48
Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 24: Activity Impairment
Časové okno: Baseline; Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.
Baseline; Week 24
Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Activity Impairment
Časové okno: Baseline; Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The WPAI is a questionnaire to evaluate the effect of anemia associated with Chronic Kidney Disease on the ability to work and perform regular activities. Scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact and 100% representing complete impact.
Baseline; Week 48
Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Score at Week 24
Časové okno: Baseline; Week 24
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Participants were asked to respond to 13 statements (as they apply to the last 7 days) that other people with the same illness said are important with one of the following: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. All individual items were summed to create a single fatigue score ranging from 0 to 52. Higher scores indicate greater fatigue.
Baseline; Week 24
Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue Scale Score at Week 48
Časové okno: Baseline; Week 48
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Participants were asked to respond to 13 statements (as they apply to the last 7 days) that other people with the same illness said are important with one of the following: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. All individual items were summed to create a single fatigue score ranging from 0 to 52. Higher scores indicate greater fatigue.
Baseline; Week 48
Number of Hospitalizations for Participants Who Entered the Dose Maintenance Period
Časové okno: up to Week 48
A hospitalization is defined as admission to the hospital.
up to Week 48
Duration of Hospitalizations for Participants Who Entered the Dose Maintenance Period
Časové okno: up to Week 48
A hospitalization is defined as admission to the hospital.
up to Week 48
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) for Participants Who Entered the Dose Maintenance Period
Časové okno: up to Week 48
Treatment-emergent adverse events are defined as adverse events that began after the first administration of study medication or pre-existing conditions that worsened after the first dose of study medication.
up to Week 48

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Keryx Biopharmaceuticals

Vyšetřovatelé

  • Ředitel studie: Medical Director, Keryx Biopharmaceuticals

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. srpna 2017

Primární dokončení (Aktuální)

30. srpna 2019

Dokončení studie (Aktuální)

27. září 2019

Termíny zápisu do studia

První předloženo

26. července 2017

První předloženo, které splnilo kritéria kontroly kvality

31. července 2017

První zveřejněno (Aktuální)

1. srpna 2017

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. března 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. března 2021

Naposledy ověřeno

1. března 2021

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • KRX-0502-402

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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