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Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia

7 de junio de 2022 actualizado por: Akebia Therapeutics

Phase 2a Open-Label Pilot Study to Assess the Pharmacodynamic Response, Pharmacokinetics, Safety, and Tolerability of 28-Day Repeat Oral Doses of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and/or 4

The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

10

Fase

  • Fase 2

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

  • Estados Unidos
    • Georgia
      • Augusta, Georgia, Estados Unidos
    • Texas
      • San Antonio, Texas, Estados Unidos

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 a 79 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Key Inclusion Criteria:

  • 18 to 79 years of age, inclusive
  • Chronic Kidney Disease Stage 3 or Stage 4
  • Hemoglobin (Hgb) < 10.5 g/dl
  • TSAT > 20% and CBC indicating normocytic red blood cell morphology

Key Exclusion Criteria:

  • BMI > 40
  • Red blood cell transfusion within 12 weeks.
  • Androgen therapy within the previous 21 days prior to study dosing
  • Therapy with any approved or experimental erythropoiesis stimulating agent (ESA) within the 10 weeks prior to the Screening visit
  • Participants meeting the criteria of ESA resistance within the previous 4 months
  • Individual doses of intravenous iron of 250 mg or larger within the past 21 days
  • AST or ALT >1.8x ULN.
  • Alkaline phosphatase >2x ULN.
  • Total bilirubin >1.5x ULN.
  • Uncontrolled hypertension
  • New York Heart Association Class III or IV congestive heart failure
  • Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to dosing

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: AKB-6548
Droga: AKB-6548
Different dose levels

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Change From Baseline in Hemoglobin (Hgb) on Day 29
Periodo de tiempo: Baseline; Day 29
Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates that hemoglobin concentration increased.
Baseline; Day 29

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Change From Baseline in Hematocrit on Day 29
Periodo de tiempo: Baseline; Day 29
Blood samples were collected to assess hematocrit. A positive change from baseline indicates hematocrit concentration increased.
Baseline; Day 29
Mean Change From Baseline in Total Red Blood Cell (RBC) Count on Day 29
Periodo de tiempo: Baseline; Day 29
Blood samples were collected to assess RBC count. Baseline RBC count was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates RBC count increased.
Baseline; Day 29
Mean Change From Baseline in Absolute Reticulocyte Count on Day 29
Periodo de tiempo: Baseline; Day 29
Blood samples were collected to assess reticulocyte count. Baseline absolute reticulocyte count was defined as the average of the 3 reticulocyte counts obtained prior to dosing (Screening, Pre- Baseline, and Baseline). A positive change from baseline indicates absolute reticulocyte count increased.
Baseline; Day 29
Mean Change From Baseline in Reticulocyte Hemoglobin (Hgb) Content on Day 29
Periodo de tiempo: Baseline; Day 29
Blood samples were collected to assess reticulocyte Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates reticulocyte Hgb content increased.
Baseline; Day 29
Number of Participants With Absolute Change From Baseline in Hemoglobin (Hgb) at Day 29
Periodo de tiempo: Day 29
Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline).
Day 29
Number of Participants With the Percentage Change From Baseline in Hemoglobin (Hgb) at Day 29
Periodo de tiempo: Day 29
Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline).
Day 29
Number of Participants With Percentage Change From Baseline in Hematocrit at Day 29
Periodo de tiempo: Day 29
Blood samples were collected to assess hematocrit.
Day 29
Number of Participants With Percentage Change From Baseline in Red Blood Cell (RBC) Count at Day 29
Periodo de tiempo: Day 29
Blood samples were collected to assess RBC count. Baseline RBC count was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline).
Day 29
Number of Participants With Change From Baseline in Absolute Reticulocyte Count at Day 29
Periodo de tiempo: Day 29
Blood samples were collected to assess reticulocyte count. Baseline absolute reticulocyte count was defined as the average of the 3 reticulocyte counts obtained prior to dosing (Screening, Pre- Baseline, and Baseline).
Day 29
Change From Baseline in Ferritin on Day 29
Periodo de tiempo: Baseline; Day 29
Blood samples were collected to assess ferritin. A positive change from baseline indicates ferritin content increased.
Baseline; Day 29
Change From Baseline in Iron on Day 29
Periodo de tiempo: Baseline; Day 29
Blood samples were collected to assess iron. A positive change from baseline indicates iron content increased.
Baseline; Day 29
Change From Baseline in Total Iron Binding Capacity on Day 29
Periodo de tiempo: Baseline; Day 29
Blood samples were collected to assess total iron binding capacity. A positive change from baseline indicates total iron binding capacity increased.
Baseline; Day 29
Change From Baseline in Transferrin Saturation on Day 29
Periodo de tiempo: Baseline; Day 29
Blood samples were collected to assess transferrin saturation. The transferrin saturation is the ratio of the serum iron concentration and the total iron-binding capacity, expressed as a percentage. A positive change from baseline indicates transferrin saturation increased.
Baseline; Day 29
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Periodo de tiempo: Up to 2 weeks post 28 days of treatment
An Adverse Event (AE) was defined as any untoward medical occurrence, signs, symptoms, disease, or laboratory or physiological observations occurring in a participant administered with drug, regardless of a causal relationship with that treatment or usage. This also included all suspected adverse medication reactions, reactions from medication overdose, abuse, withdrawal, sensitivity, toxicity, unrelated illnesses, including worsening a pre-existing condition, injury, or accidents. Serious Adverse Events (SAEs) was defined as any life-threatening condition; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or death.
Up to 2 weeks post 28 days of treatment
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values
Periodo de tiempo: Up to 2 weeks post 28 days of treatment
Parameters assessed for laboratory values included hematology, chemistry, urinalysis, and coagulation. The investigator was responsible for reviewing laboratory results for clinically significant changes.
Up to 2 weeks post 28 days of treatment
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values
Periodo de tiempo: Up to 2 weeks post 28 days of treatment
Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing laboratory results for clinically significant changes.
Up to 2 weeks post 28 days of treatment
Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings
Periodo de tiempo: Up to 2 weeks post 28 days of treatment
A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The investigator was responsible for reviewing laboratory results for clinical significance.
Up to 2 weeks post 28 days of treatment
Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval
Periodo de tiempo: Up to 2 weeks post 28 days of treatment
A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The parameters evaluated from the participant ECG trace included PR interval, QT interval, QRS interval, and QTc (corrected).
Up to 2 weeks post 28 days of treatment
Mean Trough Concentrations of Vadadustat at Day 8, 15, 22 and 29
Periodo de tiempo: Pre-dose at Day 8, 15, 22 and 29
Serum samples were collected from the participants at the defined time points. Trough concentration was defined as the concentration of drug in the blood immediately before the next dose is administered. Trough concentration was calculated using the validated liquid chromatography-mass spectrometry (LC-MS) and liquid chromatography-tandem mass spectrometry (LC-MS/MS) method
Pre-dose at Day 8, 15, 22 and 29

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Akebia Therapeutics

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

21 de octubre de 2010

Finalización primaria (Actual)

13 de abril de 2011

Finalización del estudio (Actual)

1 de mayo de 2011

Fechas de registro del estudio

Enviado por primera vez

5 de noviembre de 2010

Primero enviado que cumplió con los criterios de control de calidad

5 de noviembre de 2010

Publicado por primera vez (Estimar)

8 de noviembre de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de julio de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

7 de junio de 2022

Última verificación

1 de junio de 2022

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • AKB-6548-CI-0004

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

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. .

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