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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

Tracking Information
First Submitted Date  ICMJE December 20, 2013
First Posted Date  ICMJE December 27, 2013
Last Update Posted Date September 20, 2019
Actual Study Start Date  ICMJE February 10, 2014
Actual Primary Completion Date September 15, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
  • Change in local laboratory hemoglobin level from baseline [ Time Frame: Baseline up to 12 weeks ]
  • Speed of change in hemoglobin level per unit time [ Time Frame: Up to 16 weeks ]
  • Duration of treatment exposure [ Time Frame: Up to 16 weeks ]
  • Number of participants with serious adverse events as a measure of safety and tolerability [ Time Frame: Up to 16 weeks ]
  • Pharmacodynamics characterized by erythropoietin concentration [ Time Frame: Several time points up to 16 weeks ]
  • Pharmacodynamics characterized by reticulocyte count [ Time Frame: Several time points up to 16 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific)
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Anemia
  • Renal Insufficiency, Chronic
Intervention  ICMJE
  • Drug: BAY85-3934
    25mg Tablet
  • Drug: Placebo
    Matching placebo tablet
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: BAY85-3934
    • Drug: Placebo
  • 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
    Interventions:
    • Drug: BAY85-3934
    • Drug: Placebo
  • Experimental: BAY85-3934 (75mg OD)
    75 mg OD of BAY85-3934 Morning: 3 tablets BAY85-3934 25 mg Evening: 3 tablets matching placebo
    Interventions:
    • Drug: BAY85-3934
    • Drug: Placebo
  • 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
    Interventions:
    • Drug: BAY85-3934
    • Drug: Placebo
  • 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
    Interventions:
    • Drug: BAY85-3934
    • Drug: Placebo
  • Placebo Comparator: Placebo BID
    Placebo BID Morning and evening: 3 tablets of placebo matching BAY85-3934 25 mg
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2016)
121
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2013)
120
Actual Study Completion Date  ICMJE September 23, 2015
Actual Primary Completion Date September 15, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Bulgaria,   France,   Germany,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Poland,   Romania,   Spain,   Turkey,   United Kingdom
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02021370
Other Study ID Numbers  ICMJE 15141
2013-001193-14 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP