Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934 (DIALOGUE 2)
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 (Darbepoetin Alfa) in the Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment in Europe and Asia Pacific
Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to produce erythropoietin.
The purpose of this study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease.
The study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 15 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests.
The study will be conducted at 3 hospitals in the UK. Bayer HealthCare AG is funding this research.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
126
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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Nordrhein-Westfalen
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Bonn, Nordrhein-Westfalen, Allemagne, 53127
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New South Wales
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Gosford, New South Wales, Australie, 2250
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Victoria
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Reservoir, Victoria, Australie, 3073
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Dobrich, Bulgarie, 9300
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Lovech, Bulgarie, 5500
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Montana, Bulgarie, 3400
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Pazardjik, Bulgarie, 4400
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Sofia, Bulgarie, 1872
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Stara Zagora, Bulgarie, 6000
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Gyeonggido
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Bucheon-si, Gyeonggido, Corée, République de, 420-767
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Madrid, Espagne, 28007
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, Espagne, 08907
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Madrid
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San Sebastián de los Reyes, Madrid, Espagne, 28702
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Grenoble Cedex 9, France, 38043
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Pierre Benite Cedex, France, 69495
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Baja, Hongrie, 6500
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Budapest, Hongrie, 1036
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Esztergom, Hongrie, 2500
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Kaposvar, Hongrie, 7400
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Pecs, Hongrie, 7624
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Szigetvar, Hongrie, 7900
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Ashkelon, Israël, 7827804
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Hadera, Israël, 3810101
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Kfar Saba, Israël, 4428164
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Nahariya, Israël, 2210001
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Campania
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Napoli, Campania, Italie, 80138
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Lombardia
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Brescia, Lombardia, Italie, 25123
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Cremona, Lombardia, Italie, 26100
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Lecco, Lombardia, Italie, 23900
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Pavia, Lombardia, Italie, 27100
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Toscana
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Livorno, Toscana, Italie, 57023
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Chiba, Japon, 260-8712
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Fukuoka, Japon, 810-8563
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Nagano, Japon, 388-8004
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Fukuoka
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Kitakyushu, Fukuoka, Japon, 802-8555
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Okawa, Fukuoka, Japon, 831-0016
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Hokkaido
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Muroran, Hokkaido, Japon, 050-0083
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Iwate
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Morioka, Iwate, Japon, 020-0066
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Kanagawa
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Fujisawa, Kanagawa, Japon, 251-8550
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Mie
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Kuwana, Mie, Japon, 511-0061
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Bialystok, Pologne, 15-540
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Radom, Pologne, 26-610
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Bucharest, Roumanie, 010731
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Bucharest, Roumanie, 020475
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Oradea, Roumanie, 410469
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Targu-Mures, Roumanie, 540103
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Liverpool, Royaume-Uni, L7 8XP
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Cambridgeshire
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Cambridge, Cambridgeshire, Royaume-Uni, CB2 0QQ
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Ankara, Turquie, 06100
- Ankara Univ. Medical Faculty
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Ankara, Turquie, 06490
- Baskent University Medical faculty
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Izmir, Turquie, 03540
- Sifa University Medical Faculty
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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:
- Male or female subjects ≥ 18 years of age with anemia of chronic kidney disease (CKD) at screening
- Estimated glomerular filtration rate (eGFR) of < 60 mL/min/1.73 m2 (Modification of Diet in Renal Disease or the formula according to Matsuo, et al.)
- Not on dialysis and not expected to begin dialysis during the treatment period of the study (at least 16 weeks from randomization)
- Treated with darbepoetin via intravenous (IV) or subcutaneous (SC) route with a weekly, bi-weekly, or monthly dose, having had no more than one dose change within 8 weeks prior to randomization
- At least one kidney
- Mean screening hemoglobin (Hb) concentration of 10.0 to 12.0 g/dL
- Men who agree to use adequate contraception when sexually active or women without childbearing potential
Exclusion Criteria:
- Subjects with significant acute or chronic bleeding, such as overt gastrointestinal bleeding
- Active hemolysis or diagnosis of hemolytic syndrome
- History of myelodysplastic syndrome, multiple myeloma, marrow fibrosis, or pure red-cell aplasia (PRCA)
- History of hemosiderosis or hemochromatosis
- Hereditary hemoglobinopathies (such as sickle cell disease and thalassemia major)
- Aplastic anemia
- Chronic lymphoproliferative diseases
- Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy that is likely to require invasive treatment (intraocular injections or laser photocoagulation) during the study
- Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
- Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
- Uncontrolled and symptomatic hyperparathyroidism
- Uncontrolled active infection
- Previous or concurrent cancer except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, and T1) or any cancer curatively treated > 3 years prior to randomization
- 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)
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: BAY85-3934 (25mg)
Fixed starting dose of 25 mg of BAY85-3934 oral tablet (once daily dose) titrated at the scheduled dose control visits.
Titration occuring every 4-weeks will be based on the subject's hemoglobin (Hb) response and tolerability of the prior dose.
Total treatment time is 16 weeks.
Planned doses include 15, 25, 50, 75, 100, and 150 mg once daily.
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Oral doses of BAY 85-3934 will be available in multiples of 5, 25, and 75 mg tablets
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Expérimental: BAY85-3934 (50mg)
Fixed starting dose of 50 mg of BAY85-3934 oral tablet (once daily dose) titrated at the scheduled 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, and 150 mg once daily.
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Oral doses of BAY 85-3934 will be available in multiples of 5, 25, and 75 mg tablets
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Expérimental: BAY85-3934 (75mg)
Fixed starting doses of 75 mg of BAY85-3934 oral tablet (once daily dose) titrated at the scheduled 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, and 150 mg once daily.
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Oral doses of BAY 85-3934 will be available in multiples of 5, 25, and 75 mg tablets
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Comparateur actif: Darbepoetin alfa
Darbepoetin (intravenous or subcutaneous) will be administered according to the local label and titrated at the scheduled dose control visits.
Titration will be based on the subject's Hb response and tolerability of the prior dose.
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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 week 12 to 16
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Baseline and week 12 to 16
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Maintenance in hemoglobin target range (10.0 to 12.0 g/dL)
Délai: Up to 16 weeks
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Up to 16 weeks
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Change in hemoglobin level
Délai: Baseline up to 16 weeks
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Baseline up to 16 weeks
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Number of patients with hemoglobin levels outside the target range
Délai: Week 12 to 16
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Week 12 to 16
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Dose level in the evaluation period
Délai: Week 12 to 16
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Week 12 to 16
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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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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 janvier 2014
Achèvement primaire (Réel)
15 octobre 2015
Achèvement de l'étude (Réel)
23 novembre 2015
Dates d'inscription aux études
Première soumission
20 décembre 2013
Première soumission répondant aux critères de contrôle qualité
20 décembre 2013
Première publication (Estimation)
27 décembre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 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
- 15261
- 2013-001192-21 (Numéro EudraCT)
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