- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03236246
KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial) (COMPASS)
10 de marzo de 2021 actualizado por: 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).
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
206
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Arizona
-
Phoenix, Arizona, Estados Unidos, 85032
- Arizona Kidney Disease and Hypertension center: AKDHC Medical Research Services, LLC
-
-
California
-
Chula Vista, California, Estados Unidos, 91910
- California Institute of Renal Research
-
El Centro, California, Estados Unidos, 92243
- California Institute of Renal Research
-
Poway, California, Estados Unidos, 92064
- California Institute of Renal Research
-
-
Colorado
-
Denver, Colorado, Estados Unidos, 80230
- Denver Nephrologists, P.C.
-
-
Florida
-
Miami, Florida, Estados Unidos, 33143
- Miami Kidney Group
-
Miami, Florida, Estados Unidos, 33150
- Kidney and Hypertension Specialists of Miami, P.A.
-
-
Georgia
-
Augusta, Georgia, Estados Unidos, 30904
- Southeastern Clinical Research Institute, LLC
-
Columbus, Georgia, Estados Unidos, 31904
- Renal Associates, LLC
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60643
- Research by Design, LLC
-
-
Mississippi
-
Gulfport, Mississippi, Estados Unidos, 39501
- South Mississippi Medical Research, LLC
-
-
Missouri
-
Kansas City, Missouri, Estados Unidos, 64111
- Clinical Research Consultants
-
-
Nevada
-
Reno, Nevada, Estados Unidos, 89511
- Sierra Nevada Nephrology Consultants
-
-
New Jersey
-
Eatontown, New Jersey, Estados Unidos, 07724
- Hypertension and Nephrology Association
-
-
New York
-
Great Neck, New York, Estados Unidos, 11021
- Division of Kidney/HTN Research
-
-
North Carolina
-
Asheville, North Carolina, Estados Unidos, 28801
- Mountain Kidney & Hypertension Associates
-
Charlotte, North Carolina, Estados Unidos, 28207
- Metrolina Nephrology Associates, PA
-
Greenville, North Carolina, Estados Unidos, 27834
- Eastern Nephrology Associates
-
Jacksonville, North Carolina, Estados Unidos, 28546
- Southeastern Nephrology Associates
-
New Bern, North Carolina, Estados Unidos, 28562
- Eastern Nephrology Associates
-
Wilmington, North Carolina, Estados Unidos, 28401
- Southeastern Nephrology
-
-
South Carolina
-
Columbia, South Carolina, Estados Unidos, 29203
- Columbia Nephrology Associates, PA
-
Orangeburg, South Carolina, Estados Unidos, 29118
- South Carolina Nephrology & Hypertension Center, Inc
-
-
Tennessee
-
Nashville, Tennessee, Estados Unidos, 37205
- Nephrology Associates, P.C.
-
-
Texas
-
Austin, Texas, Estados Unidos, 78758
- Research Management, Inc.
-
Austin, Texas, Estados Unidos, 78751
- Research Management, Inc.
-
Lufkin, Texas, Estados Unidos, 75904
- P & I Clinical Research, LLC
-
San Antonio, Texas, Estados Unidos, 78212
- Clinical Advancement Center, PLLC
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Group 1
KRX-0502 1 tablet thrice daily (TID) with meals
|
Oral ferric citrate with meals
Otros nombres:
|
Experimental: Group 2
KRX-0502 2 tablets twice daily (BID) with the largest 2 daily meals
|
Oral ferric citrate with meals
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change From Baseline in Hemoglobin (Hgb) at Week 24
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change From Baseline in Hgb at Week 48
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Medical Director, Keryx Biopharmaceuticals
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de agosto de 2017
Finalización primaria (Actual)
30 de agosto de 2019
Finalización del estudio (Actual)
27 de septiembre de 2019
Fechas de registro del estudio
Enviado por primera vez
26 de julio de 2017
Primero enviado que cumplió con los criterios de control de calidad
31 de julio de 2017
Publicado por primera vez (Actual)
1 de agosto de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de marzo de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
10 de marzo de 2021
Última verificación
1 de marzo de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KRX-0502-402
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre KRX-0502
-
Keryx BiopharmaceuticalsCollaborative Study Group (CSG)TerminadoHiperfosfatemia | Enfermedad renal en etapa terminalEstados Unidos
-
Keryx BiopharmaceuticalsCollaborative Study Group (CSG)TerminadoEnfermedad renal en etapa terminal | HiperfosfatemiaEstados Unidos, Puerto Rico
-
Keryx BiopharmaceuticalsTerminadoHiperfosfatemia | Enfermedad renal en etapa terminal | Insuficiencia renal crónica que requiere hemodiálisisIsrael
-
Keryx BiopharmaceuticalsReclutamientoHiperfosfatemia relacionada con la enfermedad renal crónicaEstados Unidos
-
Keryx BiopharmaceuticalsTerminadoAnemia de la enfermedad renal crónicaEstados Unidos
-
Keryx BiopharmaceuticalsTerminadoLa anemia por deficiencia de hierro | Deficiencia de hierroEstados Unidos
-
Keryx BiopharmaceuticalsTerminadoAnemia de la enfermedad renal crónicaIsrael
-
Keryx BiopharmaceuticalsTerminadoInsuficiencia renal | Enfermedad renal en etapa terminal | ESRD | Insuficiencia renal | HiperfosfatemiaEstados Unidos, Puerto Rico
-
Keryx BiopharmaceuticalsAún no reclutandoAnemia ferropénica asociada a enfermedad renal crónica no dependiente de diálisis
-
InventisBio Co., LtdTerminadoVoluntaria saludableEstados Unidos