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 uppdaterad 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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
201
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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California
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Azusa, California, Förenta staterna, 91702
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Long Beach, California, Förenta staterna, 90813
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Los Angeles, California, Förenta staterna, 90025
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Lynwood, California, Förenta staterna, 90262
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Northridge, California, Förenta staterna, 91324
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San Dimas, California, Förenta staterna, 91773
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Whittier, California, Förenta staterna, 90606
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Whittier, California, Förenta staterna, 90602
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Florida
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New Port Richey, Florida, Förenta staterna, 34652
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Pembroke Pines, Florida, Förenta staterna, 33028
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Michigan
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Detroit, Michigan, Förenta staterna, 48236
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Detroit, Michigan, Förenta staterna, 48202
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Missouri
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Creve Coeur, Missouri, Förenta staterna, 63141
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New Jersey
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Eatontown, New Jersey, Förenta staterna, 07724
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New York
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Brooklyn, New York, Förenta staterna, 11212
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Buffalo, New York, Förenta staterna, 14215
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Fresh Meadows, New York, Förenta staterna, 11365
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45206
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Toledo, Ohio, Förenta staterna, 43615
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73116
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37212-8150
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Texas
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Fort Worth, Texas, Förenta staterna, 76104
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Fort Worth, Texas, Förenta staterna, 76105
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Fort Worth, Texas, Förenta staterna, 76164
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Grand Prairie, Texas, Förenta staterna, 75050
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Houston, Texas, Förenta staterna, 77004
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Houston, Texas, Förenta staterna, 77091
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Mansfield, Texas, Förenta staterna, 76063
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San Antonio, Texas, Förenta staterna, 78229
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San Antonio, Texas, Förenta staterna, 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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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Experimentell: 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.
|
Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
|
|
Experimentell: 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.,
|
Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
Tidsram: Baseline and weeks 14 to 17
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Baseline and weeks 14 to 17
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Duration of exposure on each dose level
Tidsram: Up to 16 weeks
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Up to 16 weeks
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Number of subjects requiring titration of dose
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: From week 14 to 17
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From week 14 to 17
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Dose level in the evaluation period
Tidsram: Up to 16 weeks
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Up to 16 weeks
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
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Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
28 oktober 2013
Primärt slutförande (Faktisk)
23 oktober 2015
Avslutad studie (Faktisk)
15 december 2015
Studieregistreringsdatum
Först inskickad
18 oktober 2013
Först inskickad som uppfyllde QC-kriterierna
29 oktober 2013
Första postat (Uppskatta)
5 november 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 september 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 september 2019
Senast verifierad
1 september 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 16208
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