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

10 марта 2021 г. обновлено: 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).

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

206

Фаза

  • Фаза 4

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Group 1
KRX-0502 1 tablet thrice daily (TID) with meals
Лекарство: KRX-0502
Oral ferric citrate with meals
Другие имена:
  • цитрат железа
Экспериментальный: Group 2
KRX-0502 2 tablets twice daily (BID) with the largest 2 daily meals
Лекарство: KRX-0502
Oral ferric citrate with meals
Другие имена:
  • цитрат железа

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change From Baseline in Hemoglobin (Hgb) at Week 24
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change From Baseline in Hgb at Week 48
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Keryx Biopharmaceuticals

Следователи

  • Директор по исследованиям: Medical Director, Keryx Biopharmaceuticals

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

15 августа 2017 г.

Первичное завершение (Действительный)

30 августа 2019 г.

Завершение исследования (Действительный)

27 сентября 2019 г.

Даты регистрации исследования

Первый отправленный

26 июля 2017 г.

Впервые представлено, что соответствует критериям контроля качества

31 июля 2017 г.

Первый опубликованный (Действительный)

1 августа 2017 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

12 марта 2021 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

10 марта 2021 г.

Последняя проверка

1 марта 2021 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • KRX-0502-402

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования KRX-0502

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