Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934 (DIALOGUE4)
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 (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
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
201
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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California
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Azusa, California, Forente stater, 91702
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Long Beach, California, Forente stater, 90813
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Los Angeles, California, Forente stater, 90025
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Lynwood, California, Forente stater, 90262
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Northridge, California, Forente stater, 91324
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San Dimas, California, Forente stater, 91773
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Whittier, California, Forente stater, 90606
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Whittier, California, Forente stater, 90602
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Florida
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New Port Richey, Florida, Forente stater, 34652
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Pembroke Pines, Florida, Forente stater, 33028
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Michigan
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Detroit, Michigan, Forente stater, 48236
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Detroit, Michigan, Forente stater, 48202
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Missouri
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Creve Coeur, Missouri, Forente stater, 63141
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New Jersey
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Eatontown, New Jersey, Forente stater, 07724
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New York
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Brooklyn, New York, Forente stater, 11212
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Buffalo, New York, Forente stater, 14215
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Fresh Meadows, New York, Forente stater, 11365
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Ohio
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Cincinnati, Ohio, Forente stater, 45206
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Toledo, Ohio, Forente stater, 43615
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73116
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Tennessee
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Nashville, Tennessee, Forente stater, 37212-8150
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Texas
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Fort Worth, Texas, Forente stater, 76104
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Fort Worth, Texas, Forente stater, 76105
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Fort Worth, Texas, Forente stater, 76164
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Grand Prairie, Texas, Forente stater, 75050
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Houston, Texas, Forente stater, 77004
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Houston, Texas, Forente stater, 77091
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Mansfield, Texas, Forente stater, 76063
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San Antonio, Texas, Forente stater, 78229
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San Antonio, Texas, Forente stater, 78215
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Kyoto, Japan, 607-8116
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Nagano, Japan, 388-8004
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Hokkaido
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Muroran, Hokkaido, Japan, 050-0083
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Hyogo
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Himeji, Hyogo, Japan, 670-0947
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Mie
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Kuwana, Mie, Japan, 511-0061
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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:
- - 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
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: 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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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Aktiv komparator: 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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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 weeks 14 to 17
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Baseline and weeks 14 to 17
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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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Mean of the hemoglobin (Hb) levels in the target range (10.0 to 11.0 g/dL)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: From week 14 to 17
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From week 14 to 17
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Dose level in the evaluation period
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
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Hjelpsomme linker
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. oktober 2013
Primær fullføring (Faktiske)
23. oktober 2015
Studiet fullført (Faktiske)
15. desember 2015
Datoer for studieregistrering
Først innsendt
18. oktober 2013
Først innsendt som oppfylte QC-kriteriene
29. oktober 2013
Først lagt ut (Anslag)
5. november 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. 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
- 16208
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. .