- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03236246
KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial) (COMPASS)
10. marts 2021 opdateret af: 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).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
206
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater, 85032
- Arizona Kidney Disease and Hypertension center: AKDHC Medical Research Services, LLC
-
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California
-
Chula Vista, California, Forenede Stater, 91910
- California Institute of Renal Research
-
El Centro, California, Forenede Stater, 92243
- California Institute of Renal Research
-
Poway, California, Forenede Stater, 92064
- California Institute of Renal Research
-
-
Colorado
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Denver, Colorado, Forenede Stater, 80230
- Denver Nephrologists, P.C.
-
-
Florida
-
Miami, Florida, Forenede Stater, 33143
- Miami Kidney Group
-
Miami, Florida, Forenede Stater, 33150
- Kidney and Hypertension Specialists of Miami, P.A.
-
-
Georgia
-
Augusta, Georgia, Forenede Stater, 30904
- Southeastern Clinical Research Institute, LLC
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Columbus, Georgia, Forenede Stater, 31904
- Renal Associates, LLC
-
-
Illinois
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Chicago, Illinois, Forenede Stater, 60643
- Research by Design, LLC
-
-
Mississippi
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Gulfport, Mississippi, Forenede Stater, 39501
- South Mississippi Medical Research, LLC
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-
Missouri
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Kansas City, Missouri, Forenede Stater, 64111
- Clinical Research Consultants
-
-
Nevada
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Reno, Nevada, Forenede Stater, 89511
- Sierra Nevada Nephrology Consultants
-
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New Jersey
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Eatontown, New Jersey, Forenede Stater, 07724
- Hypertension and Nephrology Association
-
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New York
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Great Neck, New York, Forenede Stater, 11021
- Division of Kidney/HTN Research
-
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28801
- Mountain Kidney & Hypertension Associates
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Charlotte, North Carolina, Forenede Stater, 28207
- Metrolina Nephrology Associates, PA
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Greenville, North Carolina, Forenede Stater, 27834
- Eastern Nephrology Associates
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Jacksonville, North Carolina, Forenede Stater, 28546
- Southeastern Nephrology Associates
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New Bern, North Carolina, Forenede Stater, 28562
- Eastern Nephrology Associates
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Wilmington, North Carolina, Forenede Stater, 28401
- Southeastern Nephrology
-
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South Carolina
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Columbia, South Carolina, Forenede Stater, 29203
- Columbia Nephrology Associates, PA
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Orangeburg, South Carolina, Forenede Stater, 29118
- South Carolina Nephrology & Hypertension Center, Inc
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37205
- Nephrology Associates, P.C.
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Texas
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Austin, Texas, Forenede Stater, 78758
- Research Management, Inc.
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Austin, Texas, Forenede Stater, 78751
- Research Management, Inc.
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Lufkin, Texas, Forenede Stater, 75904
- P & I Clinical Research, LLC
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San Antonio, Texas, Forenede Stater, 78212
- Clinical Advancement Center, PLLC
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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:
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Group 1
KRX-0502 1 tablet thrice daily (TID) with meals
|
Oral ferric citrate with meals
Andre navne:
|
Eksperimentel: Group 2
KRX-0502 2 tablets twice daily (BID) with the largest 2 daily meals
|
Oral ferric citrate with meals
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change From Baseline in Hemoglobin (Hgb) at Week 24
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change From Baseline in Hgb at Week 48
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Medical Director, Keryx Biopharmaceuticals
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 (Faktiske)
15. august 2017
Primær færdiggørelse (Faktiske)
30. august 2019
Studieafslutning (Faktiske)
27. september 2019
Datoer for studieregistrering
Først indsendt
26. juli 2017
Først indsendt, der opfyldte QC-kriterier
31. juli 2017
Først opslået (Faktiske)
1. august 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. marts 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. marts 2021
Sidst verificeret
1. marts 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KRX-0502-402
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
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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-
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-
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-
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-
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