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

Anemia Clinical Trial

— DIALOGUE 1  

Official title:

A Randomized, Placebo-controlled, Double-blind, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of 5 Fixed Doses of BAY85-3934 Administered Orally in the Correction of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease Not Currently Treated With Erythropoiesis-stimulating Agent in Europe and Asia Pacific

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021370
• Other study ID #: 15141
• Secondary ID: 2013-001193-14
• Status: Completed
• Phase: Phase 2
• Start date: February 10, 2014
• Est. completion date: September 23, 2015

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: September 23, 2015
• Est. primary completion date: September 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Anemia
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• BAY85-3934
25mg Tablet
• Placebo
Matching placebo tablet

Locations

Country	Name	City	State
Turkey	Ankara Univ. Medical Faculty	Ankara
Turkey	Baskent University Medical Faculty	Ankara
Turkey	Sifa University Medical Faculty	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Australia,  Bulgaria,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Poland,  Romania,  Spain,  Turkey,  United Kingdom, 

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

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