- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03236246
KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial) (COMPASS)
10 marzo 2021 aggiornato da: 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).
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
206
Fase
- Fase 4
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Arizona
-
Phoenix, Arizona, Stati Uniti, 85032
- Arizona Kidney Disease and Hypertension center: AKDHC Medical Research Services, LLC
-
-
California
-
Chula Vista, California, Stati Uniti, 91910
- California Institute of Renal Research
-
El Centro, California, Stati Uniti, 92243
- California Institute of Renal Research
-
Poway, California, Stati Uniti, 92064
- California Institute of Renal Research
-
-
Colorado
-
Denver, Colorado, Stati Uniti, 80230
- Denver Nephrologists, P.C.
-
-
Florida
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Miami, Florida, Stati Uniti, 33143
- Miami Kidney Group
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Miami, Florida, Stati Uniti, 33150
- Kidney and Hypertension Specialists of Miami, P.A.
-
-
Georgia
-
Augusta, Georgia, Stati Uniti, 30904
- Southeastern Clinical Research Institute, LLC
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Columbus, Georgia, Stati Uniti, 31904
- Renal Associates, LLC
-
-
Illinois
-
Chicago, Illinois, Stati Uniti, 60643
- Research by Design, LLC
-
-
Mississippi
-
Gulfport, Mississippi, Stati Uniti, 39501
- South Mississippi Medical Research, LLC
-
-
Missouri
-
Kansas City, Missouri, Stati Uniti, 64111
- Clinical Research Consultants
-
-
Nevada
-
Reno, Nevada, Stati Uniti, 89511
- Sierra Nevada Nephrology Consultants
-
-
New Jersey
-
Eatontown, New Jersey, Stati Uniti, 07724
- Hypertension and Nephrology Association
-
-
New York
-
Great Neck, New York, Stati Uniti, 11021
- Division of Kidney/HTN Research
-
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North Carolina
-
Asheville, North Carolina, Stati Uniti, 28801
- Mountain Kidney & Hypertension Associates
-
Charlotte, North Carolina, Stati Uniti, 28207
- Metrolina Nephrology Associates, PA
-
Greenville, North Carolina, Stati Uniti, 27834
- Eastern Nephrology Associates
-
Jacksonville, North Carolina, Stati Uniti, 28546
- Southeastern Nephrology Associates
-
New Bern, North Carolina, Stati Uniti, 28562
- Eastern Nephrology Associates
-
Wilmington, North Carolina, Stati Uniti, 28401
- Southeastern Nephrology
-
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South Carolina
-
Columbia, South Carolina, Stati Uniti, 29203
- Columbia Nephrology Associates, PA
-
Orangeburg, South Carolina, Stati Uniti, 29118
- South Carolina Nephrology & Hypertension Center, Inc
-
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37205
- Nephrology Associates, P.C.
-
-
Texas
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Austin, Texas, Stati Uniti, 78758
- Research Management, Inc.
-
Austin, Texas, Stati Uniti, 78751
- Research Management, Inc.
-
Lufkin, Texas, Stati Uniti, 75904
- P & I Clinical Research, LLC
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San Antonio, Texas, Stati Uniti, 78212
- Clinical Advancement Center, PLLC
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Group 1
KRX-0502 1 tablet thrice daily (TID) with meals
|
Oral ferric citrate with meals
Altri nomi:
|
Sperimentale: Group 2
KRX-0502 2 tablets twice daily (BID) with the largest 2 daily meals
|
Oral ferric citrate with meals
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change From Baseline in Hemoglobin (Hgb) at Week 24
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change From Baseline in Hgb at Week 48
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Medical Director, Keryx Biopharmaceuticals
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
15 agosto 2017
Completamento primario (Effettivo)
30 agosto 2019
Completamento dello studio (Effettivo)
27 settembre 2019
Date di iscrizione allo studio
Primo inviato
26 luglio 2017
Primo inviato che soddisfa i criteri di controllo qualità
31 luglio 2017
Primo Inserito (Effettivo)
1 agosto 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 marzo 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 marzo 2021
Ultimo verificato
1 marzo 2021
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- KRX-0502-402
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su KRX-0502
-
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-
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-
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-
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-
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-
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-
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-
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