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NCT Number: NCT02021370

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

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.

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Key information

Conditions

Anemia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gosford, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY85-3934

Drug

25mg Tablet

Placebo

Drug

Matching placebo tablet

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Acronym: DIALOGUE 1

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 27, 2013
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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