Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934 (DIALOGUE 2)

September 17, 2019 updated by: Bayer

A Randomized, Parallel Group, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Darbepoetin Alfa) in the Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment in 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 15 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 3 hospitals in the UK. Bayer HealthCare AG is funding this research.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Gosford, New South Wales, Australia, 2250
    • Victoria
      • Reservoir, Victoria, Australia, 3073
  • Bulgaria
      • Dobrich, Bulgaria, 9300
      • Lovech, Bulgaria, 5500
      • Montana, Bulgaria, 3400
      • Pazardjik, Bulgaria, 4400
      • Sofia, Bulgaria, 1872
      • Stara Zagora, Bulgaria, 6000
  • France
      • Grenoble Cedex 9, France, 38043
      • Pierre Benite Cedex, France, 69495
  • Germany
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53127
  • Hungary
      • Baja, Hungary, 6500
      • Budapest, Hungary, 1036
      • Esztergom, Hungary, 2500
      • Kaposvar, Hungary, 7400
      • Pecs, Hungary, 7624
      • Szigetvar, Hungary, 7900
  • Israel
      • Ashkelon, Israel, 7827804
      • Hadera, Israel, 3810101
      • Kfar Saba, Israel, 4428164
      • Nahariya, Israel, 2210001
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80138
    • Lombardia
      • Brescia, Lombardia, Italy, 25123
      • Cremona, Lombardia, Italy, 26100
      • Lecco, Lombardia, Italy, 23900
      • Pavia, Lombardia, Italy, 27100
    • Toscana
      • Livorno, Toscana, Italy, 57023
  • Japan
      • Chiba, Japan, 260-8712
      • Fukuoka, Japan, 810-8563
      • Nagano, Japan, 388-8004
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 802-8555
      • Okawa, Fukuoka, Japan, 831-0016
    • Hokkaido
      • Muroran, Hokkaido, Japan, 050-0083
    • Iwate
      • Morioka, Iwate, Japan, 020-0066
    • Kanagawa
      • Fujisawa, Kanagawa, Japan, 251-8550
    • Mie
      • Kuwana, Mie, Japan, 511-0061
  • Korea, Republic of
    • Gyeonggido
      • Bucheon-si, Gyeonggido, Korea, Republic of, 420-767
  • Poland
      • Bialystok, Poland, 15-540
      • Radom, Poland, 26-610
  • Romania
      • Bucharest, Romania, 010731
      • Bucharest, Romania, 020475
      • Oradea, Romania, 410469
      • Targu-Mures, Romania, 540103
  • Spain
      • Madrid, Spain, 28007
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
    • Madrid
      • San Sebastián de los Reyes, Madrid, Spain, 28702
  • Turkey
      • Ankara, Turkey, 06100
        • Ankara Univ. Medical Faculty
      • Ankara, Turkey, 06490
        • Baskent University Medical Faculty
      • Izmir, Turkey, 03540
        • Sifa University Medical Faculty
  • United Kingdom
      • Liverpool, United Kingdom, L7 8XP
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects ≥ 18 years of age with anemia of chronic kidney disease (CKD) at screening
  • Estimated glomerular filtration rate (eGFR) of < 60 mL/min/1.73 m2 (Modification of Diet in Renal Disease 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)
  • Treated with darbepoetin via intravenous (IV) or subcutaneous (SC) route with a weekly, bi-weekly, or monthly dose, having had no more than one dose change within 8 weeks prior to randomization
  • At least one kidney
  • Mean screening hemoglobin (Hb) concentration of 10.0 to 12.0 g/dL
  • Men who agree to use adequate contraception when sexually active or women without childbearing potential

Exclusion Criteria:

  • Subjects with significant acute or chronic bleeding, such as overt gastrointestinal bleeding
  • Active hemolysis or diagnosis of hemolytic syndrome
  • History of myelodysplastic syndrome, multiple myeloma, marrow fibrosis, or pure red-cell aplasia (PRCA)
  • History of hemosiderosis or hemochromatosis
  • Hereditary hemoglobinopathies (such as sickle cell disease and thalassemia major)
  • Aplastic anemia
  • Chronic lymphoproliferative diseases
  • Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy that is likely to require invasive treatment (intraocular injections or laser photocoagulation) during the study
  • Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
  • Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
  • Uncontrolled and symptomatic hyperparathyroidism
  • Uncontrolled active infection
  • 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
  • Any allograft (including renal allograft) in place and on immunosuppressive therapy or a scheduled kidney transplant within the next 16 weeks (being on a waiting list does not exclude the subject)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BAY85-3934 (25mg)
Fixed starting dose of 25 mg of BAY85-3934 oral tablet (once daily dose) titrated at the scheduled dose control visits. Titration occuring every 4-weeks will be based on the subject's hemoglobin (Hb) response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100, and 150 mg once daily.
Drug: BAY85-3934
Oral doses of BAY 85-3934 will be available in multiples of 5, 25, and 75 mg tablets
Experimental: BAY85-3934 (50mg)
Fixed starting dose of 50 mg of BAY85-3934 oral tablet (once daily dose) titrated at the scheduled dose control visits. Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100, and 150 mg once daily.
Drug: BAY85-3934
Oral doses of BAY 85-3934 will be available in multiples of 5, 25, and 75 mg tablets
Experimental: BAY85-3934 (75mg)
Fixed starting doses of 75 mg of BAY85-3934 oral tablet (once daily dose) titrated at the scheduled dose control visits. Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100, and 150 mg once daily.
Drug: BAY85-3934
Oral doses of BAY 85-3934 will be available in multiples of 5, 25, and 75 mg tablets
Active Comparator: Darbepoetin alfa
Darbepoetin (intravenous or subcutaneous) will be administered according to the local label and titrated at the scheduled dose control visits. Titration will be based on the subject's Hb response and tolerability of the prior dose.
Biological: Darbepoetin alfa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and week 12 to 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Maintenance in hemoglobin target range (10.0 to 12.0 g/dL)
Time Frame: Up to 16 weeks
Up to 16 weeks
Change in hemoglobin level
Time Frame: Baseline up to 16 weeks
Baseline up to 16 weeks
Number of patients with hemoglobin levels outside the target range
Time Frame: Week 12 to 16
Week 12 to 16
Dose level in the evaluation period
Time Frame: Week 12 to 16
Week 12 to 16
Duration of exposure on each dose level
Time Frame: Up to 16 weeks
Up to 16 weeks
Number of subjects requiring titration of dose
Time Frame: Up to 16 weeks
Up to 16 weeks
Number of participants with serious adverse events as a measure of safety and tolerability
Time Frame: Up to 16 weeks
Up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2014

Primary Completion (Actual)

October 15, 2015

Study Completion (Actual)

November 23, 2015

Study Registration Dates

First Submitted

December 20, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (Estimate)

December 27, 2013

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15261
  • 2013-001192-21 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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