15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific)

Phase 2

Completed

• Conditions: Anemia; Renal Insufficiency, Chronic
• Interventions: Drug: BAY85-3934; Drug: Placebo

• Registration Number: NCT02021370
• Lead Sponsor: Bayer

Brief Summary

Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to produce erythropoietin.

The purpose of this study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease.

The study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 14 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests.

The study will be conducted at 5 hospitals in the UK. Bayer HealthCare AG is funding this research.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2013-12-20
• Study First Posted: 2013-12-27
• Study Start: 2014-02-10
• Primary Completion: 2015-09-15
• Study Completion: 2015-09-23
• Disposition First Submitted: 2015-12-02
• Disposition First Submitted QC: 2015-12-02
• Disposition First Posted: 2015-12-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• Women without childbearing potential
• Male or female subjects ≥ 18 years of age with anemia of chronic kidney disease (CKD) at screening
• Estimated glomerular filtration rate of < 60 mL/min/1.73 m2 (Modification of Diet in Renal Disease [MDRD] or the formula according to Matsuo, et al)
• Not on dialysis and not expected to begin dialysis during the treatment period of the study (at least 16 weeks from randomization)
• Not treated with any erythropoiesis-stimulating agent (ESA) within 8 weeks before randomization
• Mean screening Hb concentration </= 10.5 g/dL
• Body weight of 45 kg to 125 kg, inclusive, at screening

Read More

Exclusion Criteria

• Subjects with significant acute or chronic bleeding, such as overt gastrointestinal bleeding
• Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
• Previous or concurrent cancer except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, and T1) or any cancer curatively treated > 3 years prior to randomization
• Subjects treated with any ESA within the 8 weeks before randomization
• Red blood cell (RBC) containing transfusion within the 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 initial screening visit
• Severe rhythm or conduction disorders (e.g., HR < 50 or > 110 bpm, atrial flutter, prolonged QT > 500 msec, third degree atrioventricular [AV] block)
• New York Heart Association Class III or IV congestive heart failure
• Severe hepatic insufficiency (defined as alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 x the upper limit of normal [ULN], total bilirubin > 2 mg/dL, or Child-Pugh B and C) or active hepatitis, in the investigator's opinion

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BAY85-3934 (25mg OD)	BAY85-3934	25 mg once daily (OD) of BAY85-3934 Morning: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo Evening: 3 tablets matching placebo
BAY85-3934 (25mg OD)	Placebo	25 mg once daily (OD) of BAY85-3934 Morning: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo Evening: 3 tablets matching placebo
BAY85-3934 (50mg OD)	BAY85-3934	50 mg OD of BAY85-3934 Morning: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo Evening: 3 tablets matching placebo
BAY85-3934 (50mg OD)	Placebo	50 mg OD of BAY85-3934 Morning: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo Evening: 3 tablets matching placebo
BAY85-3934 (75mg OD)	BAY85-3934	75 mg OD of BAY85-3934 Morning: 3 tablets BAY85-3934 25 mg Evening: 3 tablets matching placebo
BAY85-3934 (75mg OD)	Placebo	75 mg OD of BAY85-3934 Morning: 3 tablets BAY85-3934 25 mg Evening: 3 tablets matching placebo
BAY85-3934 (25mg BID)	BAY85-3934	25 mg twice daily (BID) of BAY85-3934 Morning and evening: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo
BAY85-3934 (25mg BID)	Placebo	25 mg twice daily (BID) of BAY85-3934 Morning and evening: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo
BAY85-3934 (50mg BID)	BAY85-3934	50 mg BID of BAY85-3934 Morning and evening: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo
BAY85-3934 (50mg BID)	Placebo	50 mg BID of BAY85-3934 Morning and evening: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo
Placebo BID	Placebo	Placebo BID Morning and evening: 3 tablets of placebo matching BAY85-3934 25 mg

Primary Outcome Measures

Name	Time	Method
Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period	Baseline and week 12 to 16

Secondary Outcome Measures

Name	Time	Method
Change in local laboratory hemoglobin level from baseline	Baseline up to 12 weeks
Speed of change in hemoglobin level per unit time	Up to 16 weeks
Duration of treatment exposure	Up to 16 weeks
Number of participants with serious adverse events as a measure of safety and tolerability	Up to 16 weeks
Pharmacodynamics characterized by erythropoietin concentration	Several time points up to 16 weeks
Pharmacodynamics characterized by reticulocyte count	Several time points up to 16 weeks

Trial Locations

Locations (3)

Sifa University Medical Faculty; 🇹🇷 Izmir, Turkey

Ankara Univ. Medical Faculty; 🇹🇷 Ankara, Turkey

Baskent University Medical Faculty; 🇹🇷 Ankara, Turkey