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

10 marca 2021 zaktualizowane przez: 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).

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Rzeczywisty)

206

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Group 1
KRX-0502 1 tablet thrice daily (TID) with meals
Lek: KRX-0502
Oral ferric citrate with meals
Inne nazwy:
  • cytrynian żelazowy
Eksperymentalny: Group 2
KRX-0502 2 tablets twice daily (BID) with the largest 2 daily meals
Lek: KRX-0502
Oral ferric citrate with meals
Inne nazwy:
  • cytrynian żelazowy

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Hemoglobin (Hgb) at Week 24
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Hgb at Week 48
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Keryx Biopharmaceuticals

Śledczy

  • Dyrektor Studium: Medical Director, Keryx Biopharmaceuticals

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

15 sierpnia 2017

Zakończenie podstawowe (Rzeczywisty)

30 sierpnia 2019

Ukończenie studiów (Rzeczywisty)

27 września 2019

Daty rejestracji na studia

Pierwszy przesłany

26 lipca 2017

Pierwszy przesłany, który spełnia kryteria kontroli jakości

31 lipca 2017

Pierwszy wysłany (Rzeczywisty)

1 sierpnia 2017

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 marca 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 marca 2021

Ostatnia weryfikacja

1 marca 2021

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • KRX-0502-402

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Przewlekłe choroby nerek

Badania kliniczne na KRX-0502

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Warunki medyczne

Interwencje lekowe

CROs by country

CROs in South Africa

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

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