Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934 (DIALOGUE4)
17 septembre 2019 mis à jour par: Bayer
A Randomized, Parallel Group, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Epoetin Alfa / Beta) in the Maintenance Treatment of Subjects With Anemia Associated With Chronic Kidney Disease Who Are on Dialysis and on Treatment With an Erythropoiesis-stimulating Agent in the United States and Japan
Evaluate efficacy and safety of 16 weeks of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta as measured by hemoglobin (Hb) levels.
Fixed starting doses of 25, 50,75 and 150 mg of BAY85-3934 titrated at the scheduled dose control visits.
Titration will be based on the subject's Hb response and tolerability of the prior dose.
Planned doses include 15, 25, 50, 75, 100,150 and 200 mg/day
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
201
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
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Kyoto, Japon, 607-8116
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Nagano, Japon, 388-8004
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Hokkaido
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Muroran, Hokkaido, Japon, 050-0083
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Hyogo
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Himeji, Hyogo, Japon, 670-0947
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Mie
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Kuwana, Mie, Japon, 511-0061
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California
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Azusa, California, États-Unis, 91702
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Long Beach, California, États-Unis, 90813
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Los Angeles, California, États-Unis, 90025
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Lynwood, California, États-Unis, 90262
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Northridge, California, États-Unis, 91324
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San Dimas, California, États-Unis, 91773
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Whittier, California, États-Unis, 90606
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Whittier, California, États-Unis, 90602
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Florida
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New Port Richey, Florida, États-Unis, 34652
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Pembroke Pines, Florida, États-Unis, 33028
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Michigan
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Detroit, Michigan, États-Unis, 48236
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Detroit, Michigan, États-Unis, 48202
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Missouri
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Creve Coeur, Missouri, États-Unis, 63141
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New Jersey
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Eatontown, New Jersey, États-Unis, 07724
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New York
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Brooklyn, New York, États-Unis, 11212
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Buffalo, New York, États-Unis, 14215
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Fresh Meadows, New York, États-Unis, 11365
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Ohio
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Cincinnati, Ohio, États-Unis, 45206
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Toledo, Ohio, États-Unis, 43615
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73116
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Tennessee
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Nashville, Tennessee, États-Unis, 37212-8150
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Texas
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Fort Worth, Texas, États-Unis, 76104
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Fort Worth, Texas, États-Unis, 76105
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Fort Worth, Texas, États-Unis, 76164
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Grand Prairie, Texas, États-Unis, 75050
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Houston, Texas, États-Unis, 77004
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Houston, Texas, États-Unis, 77091
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Mansfield, Texas, États-Unis, 76063
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San Antonio, Texas, États-Unis, 78229
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San Antonio, Texas, États-Unis, 78215
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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 et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- - Eligible subjects will have a diagnosis of anemia associated with CKD(chronic kidney disease).
- Women without childbearing potential
- Male or female subject ≥ 18 years of age with anemia of CKD at screening
- On dialysis, defined as regular long-term hemodialysis, with the same modality of dialysis for ≥ 3 months before randomization
- Dialysis vascular access via native arteriovenous fistula, synthetic graft, long-term catheters, or long-term tunneled catheters
- Treated with epoetin alfa (US or Japan) or epoetin beta (Japan) via intravenous (IV) or subcutaneous (SC) route, on stable dosing defined as a < 50% change from the maximum prescribed weekly dose with no change in the prescribed frequency during the last 8 weeks prior to randomization
- At least one kidney
- Mean screening Hb concentration 9.0 to 11.5 g/dL inclusive (mean of all local laboratory Hb measurements [at least 2 measurements must be taken ≥ 2 days apart] during the 4 week screening period, AND none of the measurements can be < 9.0 g/dL or > 12.0 g /dL
- Serum ferritin levels ≥ 100 μg/L OR transferrin saturation ≥ 20% at screening. Iron substitution is allowed
- Folate and vitamin B12 levels above the lower limit of normal. Supplementation is allowed
- Exclusion Criteria:
- Subjects with significant acute or chronic bleeding, such as overt gastrointestinal bleeding
- Hereditary hemoglobinopathies (including, but not limited to, sickle cell disease, beta thalassemia, and thalassemia major) which may be the primary cause of anemia
- Chronic lymphoproliferative diseases
- Any allograft (including renal allograft) in place and on immunosuppressive therapy, or a scheduled kidney transplant within the next 16 weeks (being on a waiting list does not exclude the subject)
- Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease)
- Subjects treated with immuno- or myelosuppressive therapy within 8 weeks prior to randomization: e.g., everolimus, sirolimus, rituximab, azathioprine, mycophenolate mofetil, mycophenolic acid, cyclosporine,methotrexate, and tacrolimus, chemotherapeutic agents and other anticancer agents, and systemic steroids (except inhaled steroids) for 7 days
- RBC-containing transfusion within 8 weeks before randomization
- History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within the last 6 months from the initial screening visit
- Sustained, poorly controlled arterial hypertension or hypotension at screening, defined as a mean BP ≥ 180/110 mmHg or systolic BP < 95 mmHg, respectively
- Severe rhythm or conduction disorder (e.g., HR < 50 or > 110 bpm, atrial flutter, prolonged QT >500 msec, second or third degree atrioventricular [AV]block if not treated with a pacemaker)
- New York Heart Association Class III or IV congestive heart failure
- Severe hepatic insufficiency (defined as alanine aminotransferase [ALT], aspartate aminotransferase [AST], or gamma-glutamyl transferase > 3 times the upper limit of normal [ULN], total bilirubin > 2 mg/dL, or Child-Pugh B or C) or active hepatitis in the investigator's opinion
- A scheduled surgery that may be expected to lead to significant blood loss
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: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Molidustat (BAY 85-3934)(25mg)
Starting dose of 25 mg of BAY85-3934 as once-daily oral tablets.
Regular titrations at dose control visits.
Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose.
Total treatment time is 16 weeks.
Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily.
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Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
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Expérimental: Molidustat (BAY 85-3934)(50mg)
Starting dose of 50 mg of BAY85-3934 as once-daily oral tablets.
Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose.
Total treatment time is 16 weeks.
Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily.
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Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
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Expérimental: Molidustat (BAY 85-3934) (75mg)
Starting dose of 75 mg of BAY85-3934 as once-daily oral tablets.
Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose.
Total treatment time is 16 weeks.
Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily.,
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Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
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Expérimental: Molidustat (BAY 85-3934) (150mg)
Starting dose of 150 mg of BAY85-3934 as once-daily oral tablets.
Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose.
Total treatment time is 16 weeks.
Planned doses include 15, 25, 50, 75, 100, 150 and 200 mg once daily
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Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
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Comparateur actif: Epoetin alfa/beta
Starting dose at the subject's current weekly dose.
Administered IV or SC 3 times per week.
Doses will be titrated at the scheduled dose control visits according to the local label.
Titration will be based on the subject's Hb response and tolerability of the prior dose.
Epoetin alfa may be administered in either the United States (US) or Japan; epoetin beta will only be administered in Japan.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
Délai: Baseline and weeks 14 to 17
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Baseline and weeks 14 to 17
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Duration of exposure on each dose level
Délai: Up to 16 weeks
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Up to 16 weeks
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Number of subjects requiring titration of dose
Délai: Up to 16 weeks
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Up to 16 weeks
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Number of participants with serious adverse events as a measure of safety and tolerability
Délai: Up to 16 weeks
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Up to 16 weeks
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Mean of the hemoglobin (Hb) levels in the target range (10.0 to 11.0 g/dL)
Délai: From week 14 to 17
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From week 14 to 17
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Mean of the hemoglobin levels in the target range (9.5 to 11.5 g/dL)
Délai: From week 14 to 17
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From week 14 to 17
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Change from baseline in Hb during active treatment
Délai: Baseline and weeks 14 to 17
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Baseline and weeks 14 to 17
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Number of patients with hemoglobin levels outside the target range
Délai: From week 14 to 17
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From week 14 to 17
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Dose level in the evaluation period
Délai: Up to 16 weeks
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Up to 16 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
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 (Réel)
28 octobre 2013
Achèvement primaire (Réel)
23 octobre 2015
Achèvement de l'étude (Réel)
15 décembre 2015
Dates d'inscription aux études
Première soumission
18 octobre 2013
Première soumission répondant aux critères de contrôle qualité
29 octobre 2013
Première publication (Estimation)
5 novembre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 septembre 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 septembre 2019
Dernière vérification
1 septembre 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 16208
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 .