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15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific) (DIALOGUE 1)

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ClinicalTrials.gov Identifier: NCT02021370
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Anemia Renal Insufficiency, Chronic Drug: BAY85-3934 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 10, 2014
Actual Primary Completion Date : September 15, 2015
Actual Study Completion Date : September 23, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Experimental: BAY85-3934 (25mg OD)
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
Drug: BAY85-3934
25mg Tablet

Drug: Placebo
Matching placebo tablet

Experimental: BAY85-3934 (50mg OD)
50 mg OD of BAY85-3934 Morning: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo Evening: 3 tablets matching placebo
Drug: BAY85-3934
25mg Tablet

Drug: Placebo
Matching placebo tablet

Experimental: BAY85-3934 (75mg OD)
75 mg OD of BAY85-3934 Morning: 3 tablets BAY85-3934 25 mg Evening: 3 tablets matching placebo
Drug: BAY85-3934
25mg Tablet

Drug: Placebo
Matching placebo tablet

Experimental: BAY85-3934 (25mg BID)
25 mg twice daily (BID) of BAY85-3934 Morning and evening: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo
Drug: BAY85-3934
25mg Tablet

Drug: Placebo
Matching placebo tablet

Experimental: BAY85-3934 (50mg BID)
50 mg BID of BAY85-3934 Morning and evening: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo
Drug: BAY85-3934
25mg Tablet

Drug: Placebo
Matching placebo tablet

Placebo Comparator: Placebo BID
Placebo BID Morning and evening: 3 tablets of placebo matching BAY85-3934 25 mg
Drug: Placebo
Matching placebo tablet




Primary Outcome Measures :
  1. Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period [ Time Frame: Baseline and week 12 to 16 ]

Secondary Outcome Measures :
  1. Change in local laboratory hemoglobin level from baseline [ Time Frame: Baseline up to 12 weeks ]
  2. Speed of change in hemoglobin level per unit time [ Time Frame: Up to 16 weeks ]
  3. Duration of treatment exposure [ Time Frame: Up to 16 weeks ]
  4. Number of participants with serious adverse events as a measure of safety and tolerability [ Time Frame: Up to 16 weeks ]
  5. Pharmacodynamics characterized by erythropoietin concentration [ Time Frame: Several time points up to 16 weeks ]
  6. Pharmacodynamics characterized by reticulocyte count [ Time Frame: Several time points up to 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021370


Locations
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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02021370    
Other Study ID Numbers: 15141
2013-001193-14 ( EudraCT Number )
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Keywords provided by Bayer:
Anemia of CKD
Additional relevant MeSH terms:
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Renal Insufficiency
Renal Insufficiency, Chronic
Anemia
Hematologic Diseases
Kidney Diseases
Urologic Diseases