Trial Condition(s):

Anemia, Renal Insufficiency, Chronic

Maintenance treatment of anemia associated with chronic kidney disease (CKD) in hemodialysis subjects on epoetin alfa / beta treatment versus BAY85-3934 (DIALOGUE4)

Bayer Identifier:

16208

ClinicalTrials.gov Identifier:

NCT01975818

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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

Trial Summary

Enrollment Goal
201
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Molidustat (BAY85-3934)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Cincinnati, United States, 45206

Status
Completed
 
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Investigative Site

San Dimas, United States, 91773

Status
Completed
 
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Investigative Site

Azusa, United States, 91702

Status
Completed
 
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San Antonio, United States, 78215

Status
Completed
 
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Nashville, United States, 37212-8150

Status
Completed
 
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Investigative Site

Los Angeles, United States, 90025

Status
Completed
 
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Whittier, United States, 90602

Status
Completed
 
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Brooklyn, United States, 11212

Status
Completed
 
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Investigative Site

Fresh Meadows, United States, 11365

Status
Completed
 
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Buffalo, United States, 14215

Status
Completed
 
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Investigative Site

Detroit, United States, 48202

Status
Completed
 
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Investigative Site

Eatontown, United States, 07724

Status
Completed
 
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Investigative Site

Toledo, United States, 43615

Status
Completed
 
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New Port Richey, United States, 34652

Status
Completed
 
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Investigative Site

Nagano, Japan, 388-8004

Status
Completed
 
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Kyoto, Japan, 607-8116

Status
Completed
 
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Investigative Site

Muroran, Japan, 050-0083

Status
Completed
 
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Investigative Site

Himeji, Japan, 670-0947

Status
Completed
 
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Houston, United States, 77091

Status
Completed
 
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Investigative Site

Mansfield, United States, 76063

Status
Completed
 
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Investigative Site

Fort Worth, United States, 76105

Status
Completed
 
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Investigative Site

Fort Worth, United States, 76104

Status
Completed
 
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Investigative Site

Fort Worth, United States, 76164

Status
Completed
 
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Investigative Site

Northridge, United States, 91324

Status
Completed
 
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Investigative Site

Kuwana, Japan, 511-0061

Status
Completed
 
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Oklahoma City, United States, 73116

Status
Completed
 
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San Antonio, United States, 78229

Status
Completed
 
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Detroit, United States, 48236

Status
Completed
 
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Investigative Site

Pembroke Pines, United States, 33028

Status
Completed
 
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Investigative Site

Creve Coeur, United States, 63141

Status
Completed
 
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Investigative Site

Long Beach, United States, 90813

Status
Completed
 
Locations

Investigative Site

Houston, United States, 77004

Status
Completed
 
Locations

Investigative Site

Lynwood, United States, 90262

Status
Completed
 
Locations

Investigative Site

Whittier, United States, 90606

Status
Completed
 
Locations

Investigative Site

Grand Prairie, United States, 75050

Status
Completed
 

Trial Design