- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02780726
A Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia
A Phase 3, Multi-center, Open-label Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
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Aichi, Japon
- Site JP00002
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Aichi, Japon
- Site JP00004
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Aichi, Japon
- Site JP00010
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Aichi, Japon
- Site JP00013
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Fukuoka, Japon
- Site JP00001
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Fukuoka, Japon
- Site JP00005
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Hokkaido, Japon
- Site JP00012
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Hokkaido, Japon
- Site JP00014
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Ishikawa, Japon
- Site JP00006
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Kanagawa, Japon
- Site JP00008
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Nagano, Japon
- Site JP00003
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Okayama, Japon
- Site JP00015
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Osaka, Japon
- Site JP00009
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Tokushima, Japon
- Site JP00007
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Toyama, Japon
- Site JP00011
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Female subject must either:
Be of non-childbearing potential:
- post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
- documented surgically sterile Or, if of childbearing potential,
- Agree not to try to become pregnant during the study and for 28 days after the final study drug administration
- And have a negative pregnancy test at Screening
And, if heterosexually active, agree to consistently use two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and continued for 28 days after the final study drug administration.
- Female subject must agree not to breastfeed starting at Screening and throughout the study period, and continued for 28 days after the final study drug administration.
- Female subject must not donate ova starting at Screening and throughout the study period, and continued for 28 days after the final study drug administration.
- Male subject and their female spouse/partners who are of childbearing potential must be using two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 12 weeks after the final study drug administration
- Male subject must not donate sperm starting at Screening and throughout the study period and, for 12 weeks after the final study drug administration
- Subjects who have not received Erythropoieses Stimulating Agents (ESAs):
- Subjects who have been receiving peritoneal dialysis for more than 4 weeks before the screening assessment
- Subjects who have never received ESAs after starting peritoneal dialysis, or subjects who have not received ESAs within 6 weeks before the screening assessment.
- Mean of the subject's two most recent Hb values before randomization during the Screening Period must be <10.5 g/dL with an absolute difference ≤1.3 g/dL between the two values
Either transferrin saturation (TSAT) ≥ 5% or serum ferritin ≥ 30 ng/mL during the screening period
- Subjects who have been receiving ESAs:
- Subjects with renal anemia who have been receiving ESA within the doses approved in Japan for more than 8 weeks after starting peritoneal dialysis, before the screening assessment
- Mean of the subject's two most recent Hb values before randomization during the Screening Period must be ≥10.0 g/dL and ≤12.0 g/dL
- TSAT ≥ 20% or serum ferritin ≥ 100 ng/mL during the screening period
Exclusion Criteria:
- Subjects who had trouble with continuing peritoneal dialysis due to peritonitis, development of catheter trouble (e.g. tunnel infection) within 4 weeks before the screening assessment
- Concurrent retinal neovascular lesion requiring treatment and macular edema requiring treatment
- Concurrent autoimmune disease with inflammation that could impact erythropoiesis
- History of gastric/intestinal resection considered influential on the absorption of drugs in the gastrointestinal tract (excluding resection of gastric or colon polyps) or concurrent gastro-paresis
- Uncontrolled hypertension
- Concurrent congestive heart failure (NYHA Class III or higher)
- History of hospitalization for treatment of stroke, myocardial infarction, or pulmonary embolism within 12 weeks before the screening assessment
- Positive for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibody at the screening assessment, or positive for human immunodeficiency virus (HIV) in a past test
- Concurrent other form of anemia than renal anemia
- Having received treatment with protein anabolic hormone, testosterone enanthate, or mepitiostane within 6 weeks before the screening assessment
- Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), total bilirubin, or Alkaline Phosphatase (ALP) that is greater than the criteria below, or previous or concurrent another serious liver disease at screening assessment
- Previous or current malignant tumor (no recurrence for at least 5 years is eligible.)
- Having undergone blood transfusion and/or a surgical procedure considered to promote anemia (excluding shunt reconstruction surgery for access to the blood) within 4 weeks before the screening assessment
- Having undergone a kidney transplantation
- Having a previous history of treatment with ASP1517
- History of serious drug allergy including anaphylactic shock
- Participation in another clinical study or post-marketing clinical study (including that of a medical device) within 12 weeks before informed consent acquisition
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: ASP1517 Low Dose Group (ESA Untreated)
This group includes subjects who have not received Erythropoieses Stimulating Agents (ESAs).
Study drug will be dosed three times weekly and dose adjustments will be made during the study.
|
Oral
Autres noms:
|
Expérimental: ASP1517 High Dose Group (ESA Untreated)
This group includes subjects who have not received ESAs.
Study drug will be dosed three times weekly and dose adjustments will be made during the study.
|
Oral
Autres noms:
|
Expérimental: ASP1517 ESAs Treated Group
This group includes subjects who have received ESAs.
The treatment was converted from ESAs to study drug.
Study drug will be dosed three times weekly and dose adjustments will be made during the study.
|
Oral
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Hemoglobin (Hb) Response Rate from Week 18 to Week 24
Délai: Up to Week 24
|
Hb response defined as average Hb within the target range in this outcome
|
Up to Week 24
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Hb Response rate
Délai: Up to Week 24
|
Hb response is defined as reaching target values for Hb and change of Hb from baseline in this outcome.
|
Up to Week 24
|
Average Hb levels from week 18 to week 24
Délai: Up to week 24
|
Up to week 24
|
|
Change from baseline in the average Hb levels of week 18 to week 24
Délai: Baseline and up to Week 24
|
Baseline and up to Week 24
|
|
Rate of rise in Hb levels (g/dL/week)
Délai: Up to Week 4
|
Up to Week 4
|
|
Proportion of time points with target Hb levels
Délai: Up to Week 24
|
Up to Week 24
|
|
Proportion of participants who achieve the target Hb level at each week
Délai: Up to Week 24
|
Up to Week 24
|
|
Proportion of participants who achieve the lower limit of the target Hb level
Délai: Up to Week 24
|
Up to Week 24
|
|
Temps nécessaire pour atteindre la limite inférieure du niveau cible d'Hb
Délai: Jusqu'à la semaine 24
|
Jusqu'à la semaine 24
|
|
Change from baseline in Hb level at each week
Délai: Baseline and Up to Week 24
|
Baseline and Up to Week 24
|
|
Efficacy assessed by hematocrit
Délai: Up to Week 24
|
Hematocrit will be summarized by ASP1517 low dose Erythropoieses Stimulating Agent (ESA) untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
|
Up to Week 24
|
Efficacy assessed by reticulocytes/ erythrocytes
Délai: Up to Week 24
|
Reticulocytes/Erythrocytes will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
|
Up to Week 24
|
Efficacy assessed by Iron (Fe)
Délai: Up to Week 24
|
Fe will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
|
Up to Week 24
|
Efficacy assessed by ferritin
Délai: Up to Week 24
|
Ferritin will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
|
Up to Week 24
|
Efficacy assessed by transferrin
Délai: Up to Week 24
|
Transferrin will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
|
Up to Week 24
|
Efficacy assessed by total iron binding capacity
Délai: Up to Week 24
|
Total iron binding capacity will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
|
Up to Week 24
|
Efficacy assessed by soluble transferrin receptor
Délai: Up to Week 24
|
Soluble transferrin receptor will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
|
Up to Week 24
|
Efficacy assessed by transferrin saturation
Délai: Up to Week 24
|
Transferrin saturation will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
|
Up to Week 24
|
Efficacy assessed by reticulocyte hemoglobin content
Délai: Up to Week 24
|
Reticulocyte hemoglobin content will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
|
Up to Week 24
|
Qualité de vie évaluée par SF-36
Délai: Jusqu'à la semaine 24
|
SF-36 : Enquête sur la santé en 36 points de l'étude sur les résultats médicaux
|
Jusqu'à la semaine 24
|
Quality of life assessed by EQ-5D
Délai: Up to Week 24
|
EQ-5D: EuroQol 5 Dimension
|
Up to Week 24
|
Qualité de vie évaluée par FACT-An
Délai: Jusqu'à la semaine 24
|
FACT-An : Évaluation fonctionnelle du traitement du cancer - Anémie
|
Jusqu'à la semaine 24
|
Occurrence of hospitalizations
Délai: Up to Week 24
|
Up to Week 24
|
|
Innocuité évaluée par l'incidence des événements indésirables
Délai: Jusqu'à la semaine 24
|
Jusqu'à la semaine 24
|
|
Nombre de participants présentant des signes vitaux anormaux et/ou des événements indésirables liés au traitement
Délai: Jusqu'à la semaine 24
|
Jusqu'à la semaine 24
|
|
Sécurité évaluée par électrocardiogramme standard à 12 dérivations
Délai: Jusqu'à la semaine 24
|
Jusqu'à la semaine 24
|
|
Nombre de participants avec des valeurs de laboratoire anormales et/ou des événements indésirables liés au traitement
Délai: Jusqu'à la semaine 24
|
Jusqu'à la semaine 24
|
|
Concentration plasmatique d'ASP1517 inchangé
Délai: Jusqu'à la semaine 24
|
Jusqu'à la semaine 24
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1517-CL-0302
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- Protocole d'étude
- Plan d'analyse statistique (PAS)
- Rapport d'étude clinique (CSR)
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 .
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