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

7 juin 2022 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

10

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Georgia
      • Augusta, Georgia, États-Unis
    • Texas
      • San Antonio, Texas, États-Unis

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 79 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: AKB-6548
Médicament: AKB-6548
Different dose levels

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mean Change From Baseline in Hemoglobin (Hgb) on Day 29
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Mean Change From Baseline in Hematocrit on Day 29
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Akebia Therapeutics

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

21 octobre 2010

Achèvement primaire (Réel)

13 avril 2011

Achèvement de l'étude (Réel)

1 mai 2011

Dates d'inscription aux études

Première soumission

5 novembre 2010

Première soumission répondant aux critères de contrôle qualité

5 novembre 2010

Première publication (Estimation)

8 novembre 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 juillet 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 juin 2022

Dernière vérification

1 juin 2022

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • AKB-6548-CI-0004

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur AKB-6548

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