Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934 (DIALOGUE 2)
17. september 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
126
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New South Wales
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Gosford, New South Wales, Australia, 2250
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Victoria
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Reservoir, Victoria, Australia, 3073
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Dobrich, Bulgaria, 9300
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Lovech, Bulgaria, 5500
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Montana, Bulgaria, 3400
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Pazardjik, Bulgaria, 4400
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Sofia, Bulgaria, 1872
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Stara Zagora, Bulgaria, 6000
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Grenoble Cedex 9, Frankrike, 38043
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Pierre Benite Cedex, Frankrike, 69495
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Ashkelon, Israel, 7827804
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Hadera, Israel, 3810101
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Kfar Saba, Israel, 4428164
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Nahariya, Israel, 2210001
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Campania
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Napoli, Campania, Italia, 80138
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Lombardia
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Brescia, Lombardia, Italia, 25123
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Cremona, Lombardia, Italia, 26100
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Lecco, Lombardia, Italia, 23900
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Pavia, Lombardia, Italia, 27100
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Toscana
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Livorno, Toscana, Italia, 57023
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Chiba, Japan, 260-8712
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Fukuoka, Japan, 810-8563
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Nagano, Japan, 388-8004
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Fukuoka
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Kitakyushu, Fukuoka, Japan, 802-8555
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Okawa, Fukuoka, Japan, 831-0016
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Hokkaido
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Muroran, Hokkaido, Japan, 050-0083
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Iwate
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Morioka, Iwate, Japan, 020-0066
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Kanagawa
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Fujisawa, Kanagawa, Japan, 251-8550
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Mie
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Kuwana, Mie, Japan, 511-0061
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Gyeonggido
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Bucheon-si, Gyeonggido, Korea, Republikken, 420-767
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Bialystok, Polen, 15-540
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Radom, Polen, 26-610
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Bucharest, Romania, 010731
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Bucharest, Romania, 020475
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Oradea, Romania, 410469
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Targu-Mures, Romania, 540103
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Madrid, Spania, 28007
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, Spania, 08907
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Madrid
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San Sebastián de los Reyes, Madrid, Spania, 28702
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Liverpool, Storbritannia, L7 8XP
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Cambridgeshire
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Cambridge, Cambridgeshire, Storbritannia, CB2 0QQ
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Ankara, Tyrkia, 06100
- Ankara Univ. Medical Faculty
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Ankara, Tyrkia, 06490
- Baskent University Medical faculty
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Izmir, Tyrkia, 03540
- Sifa University Medical Faculty
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Nordrhein-Westfalen
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Bonn, Nordrhein-Westfalen, Tyskland, 53127
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Baja, Ungarn, 6500
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Budapest, Ungarn, 1036
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Esztergom, Ungarn, 2500
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Kaposvar, Ungarn, 7400
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Pecs, Ungarn, 7624
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Szigetvar, Ungarn, 7900
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
Tidsramme: Baseline and week 12 to 16
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Baseline and week 12 to 16
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Maintenance in hemoglobin target range (10.0 to 12.0 g/dL)
Tidsramme: Up to 16 weeks
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Up to 16 weeks
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Change in hemoglobin level
Tidsramme: 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
Tidsramme: Week 12 to 16
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Week 12 to 16
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Dose level in the evaluation period
Tidsramme: Week 12 to 16
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Week 12 to 16
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Duration of exposure on each dose level
Tidsramme: Up to 16 weeks
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Up to 16 weeks
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Number of subjects requiring titration of dose
Tidsramme: 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
Tidsramme: Up to 16 weeks
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Up to 16 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
28. januar 2014
Primær fullføring (Faktiske)
15. oktober 2015
Studiet fullført (Faktiske)
23. november 2015
Datoer for studieregistrering
Først innsendt
20. desember 2013
Først innsendt som oppfylte QC-kriteriene
20. desember 2013
Først lagt ut (Anslag)
27. desember 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. september 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. september 2019
Sist bekreftet
1. september 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 15261
- 2013-001192-21 (EudraCT-nummer)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .