Trial Condition(s):

Anemia, Renal Insufficiency, Chronic

Long term extension study for the maintenance treatment of anemia associated with chronic kidney disease (CKD) in hemodialysis subjects on epoetin alfa / beta treatment versus BAY85-3934 (DIALOGUE5)

Bayer Identifier:

16209

ClinicalTrials.gov Identifier:

NCT02064426

EudraCT Number:

Not Available

Study Completed

Trial Purpose

Evaluate efficacy and safety up to 36 months of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta. Titration will be based on the subject’s hemoglobin (Hb) response and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,and 150 mg once daily.

Inclusion Criteria
- Eligible male or female subjects were previously enrolled in Study 16208, have a diagnosis of anemia associated with CKD, and are on hemodialysis.
 - Men who agree to use adequate contraception when sexually active or women without childbearing potential
 - Participation and completion of treatment in Study 16208; subjects must have received 16 weeks of study medication and completed the end of treatment visit (Day 113) in the parent study
 - Mean Hb concentration of 9.5 to 11.5 g/dL, inclusive, during the evaluation period (i.e., the last 4 weeks of the parent study) when the subject completed 16 weeks of treatment with BAY85-3934, epoetin alfa, or epoetin beta in Study 16208
Exclusion Criteria
- A scheduled kidney transplant or any other organ transplant within the next 6 months (being on a waiting list does not exclude the subject)
 - Updates to medical and surgical history which meet the exclusion criteria in the parent study
 - Subjects treated with immunosuppressive therapy and the breast cancer resistant protein (BCRP) substrates, irinotecan, topotecan, methotrexate, imatinib, and lapatinib
 - Sustained, poorly controlled arterial hypertension or hypotension at baseline, defined as mean BP ≥ 180/110 mmHg or systolic BP < 95 mmHg, respectively
 - Severe rhythm or conduction disorder (e.g., HR < 50 or > 110 bpm, atrial fibrillation or flutter, prolonged QT > 500 msec, second or third degree atrioventricular [AV] block)
 - 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 x the upper limit of norma [ULN], total bilirubin > 2 mg/dL, or Child-Pugh B or C) or active hepatitis in the investigator’s opinion
 - An ongoing SAE from Study 16208 that is assessed as related to study drug
 - Alcohol or drug abuse

Trial Summary

Enrollment Goal
88
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
 
Locations

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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Investigative Site

Nashville, United States, 37212-8150

Status
Completed
 
Locations

Investigative Site

Whittier, United States, 90602

Status
Completed
 
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Investigative Site

Buffalo, United States, 14215

Status
Completed
 
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Investigative Site

Detroit, United States, 48202

Status
Completed
 
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Investigative Site

Toledo, United States, 43615

Status
Completed
 
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Investigative Site

New Port Richey, United States, 34652

Status
Completed
 
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Investigative Site

Kyoto, Japan, 607-8116

Status
Completed
 
Locations

Investigative Site

Muroran, Japan, 050-0083

Status
Completed
 
Locations

Investigative Site

Houston, United States, 77091

Status
Completed
 
Locations

Investigative Site

Mansfield, United States, 76063

Status
Completed
 
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Investigative Site

Fort Worth, United States, 76105

Status
Completed
 
Locations

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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Investigative Site

Oklahoma City, United States, 73116

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
 
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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