Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934

Anemia Clinical Trial

— DIALOGUE4  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01975818
• Other study ID #: 16208
• Status: Completed
• Phase: Phase 2
• Start date: October 28, 2013
• Est. completion date: December 15, 2015

Study information

• Verified date: September 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: December 15, 2015
• Est. primary completion date: October 23, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Molidustat (BAY 85-3934)
Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets

Biological:
• Epoetin alfa/beta

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period		Baseline and weeks 14 to 17
Secondary	Mean of the hemoglobin (Hb) levels in the target range (10.0 to 11.0 g/dL)		From week 14 to 17
Secondary	Mean of the hemoglobin levels in the target range (9.5 to 11.5 g/dL)		From week 14 to 17
Secondary	Change from baseline in Hb during active treatment		Baseline and weeks 14 to 17
Secondary	Number of patients with hemoglobin levels outside the target range		From week 14 to 17
Secondary	Dose level in the evaluation period		Up to 16 weeks
Secondary	Duration of exposure on each dose level		Up to 16 weeks
Secondary	Number of subjects requiring titration of dose		Up to 16 weeks
Secondary	Number of participants with serious adverse events as a measure of safety and tolerability		Up to 16 weeks

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