Trial Condition(s):

Anemia, Renal Insufficiency, Chronic

Maintenance treatment of anemia in pre-dialysis subjects with chronic kidney disease on darbepoetin treatment versus BAY85-3934 (DIALOGUE 2)

Bayer Identifier:

15261

ClinicalTrials.gov Identifier:

NCT02021409

EudraCT Number:

2013-001192-21

Study Completed

Trial Purpose

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.

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)

Trial Summary

Enrollment Goal
126
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Molidustat (BAY85-3934)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Pavia, Italy, 27100

Status
Completed
 
Locations

Investigative Site

Cremona, Italy, 26100

Status
Completed
 
Locations

Investigative Site

Livorno, Italy, 57023

Status
Completed
 
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Investigative Site

Reservoir, Australia, 3073

Status
Completed
 
Locations

Investigative Site

Gosford, Australia, 2250

Status
Completed
 
Locations

Investigative Site

Cambridge, United Kingdom, CB2 0QQ

Status
Completed
 
Locations

Investigative Site

Liverpool, United Kingdom, L7 8XP

Status
Completed
 
Locations

Investigative Site

Nagano, Japan, 388-8004

Status
Completed
 
Locations

Investigative Site

Kitakyushu, Japan, 802-8555

Status
Completed
 
Locations

Investigative Site

Muroran, Japan, 050-0083

Status
Completed
 
Locations

Investigative Site

Fukuoka, Japan, 810-8563

Status
Completed
 
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Investigative Site

Pecs, Hungary, 7624

Status
Completed
 
Locations

Investigative Site

Esztergom, Hungary, 2500

Status
Completed
 
Locations

Investigative Site

Baja, Hungary, 6500

Status
Completed
 
Locations

Investigative Site

Targu-Mures, Romania, 540103

Status
Completed
 
Locations

Investigative Site

Oradea, Romania, 410469

Status
Completed
 
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Investigative Site

Pazardjik, Bulgaria, 4400

Status
Completed
 
Locations

Investigative Site

Montana, Bulgaria, 3400

Status
Completed
 
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Investigative Site

Lovech, Bulgaria, 5500

Status
Completed
 
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Investigative Site

Bucheon-si, South Korea, 420-767

Status
Completed
 
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Investigative Site

Lecco, Italy, 23900

Status
Completed
 
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Investigative Site

Bucharest, Romania, 020475

Status
Completed
 
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Investigative Site

Fujisawa, Japan, 251-8550

Status
Completed
 
Locations

Investigative Site

Bucharest, Romania, 010731

Status
Completed
 
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Investigative Site

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
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Investigative Site

Madrid, Spain, 28007

Status
Completed
 
Locations

Investigative Site

San Sebastián de los Reyes, Spain, 28702

Status
Completed
 
Locations

Investigative Site

PIERRE BENITE CEDEX, France, 69495

Status
Completed
 
Locations

Investigative Site

GRENOBLE CEDEX 9, France, 38043

Status
Completed
 
Locations

Investigative Site

Kuwana, Japan, 511-0061

Status
Completed
 
Locations

Investigative Site

Kaposvar, Hungary, 7400

Status
Completed
 
Locations

Investigative Site

Szigetvar, Hungary, 7900

Status
Completed
 
Locations

Investigative Site

Radom, Poland, 26-610

Status
Completed
 
Locations

Investigative Site

Okawa, Japan, 831-0016

Status
Completed
 
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Investigative Site

Stara Zagora, Bulgaria, 6000

Status
Completed
 
Locations

Investigative Site

Bialystok, Poland, 15-540

Status
Completed
 
Locations

Investigative Site

Chiba, Japan, 260-8712

Status
Completed
 
Locations

Investigative Site

Bonn, Germany, 53127

Status
Completed
 
Locations

Investigative Site

Morioka, Japan, 020-0066

Status
Completed
 
Locations

Investigative Site

Napoli, Italy, 80138

Status
Completed
 
Locations

Investigative Site

Kfar Saba, Israel, 4428164

Status
Completed
 
Locations

Investigative Site

Ashkelon, Israel, 7827804

Status
Completed
 
Locations

Investigative Site

Dobrich, Bulgaria, 9300

Status
Completed
 
Locations

Investigative Site

Brescia, Italy, 25123

Status
Completed
 
Locations

Investigative Site

Hadera, Israel, 3810101

Status
Completed
 
Locations

Investigative Site

Nahariya, Israel, 2210001

Status
Completed
 
Locations

Ankara Univ. Medical Faculty

Ankara, Turkey, 06100

Status
Terminated
 
Locations

Baskent University Medical Faculty

Ankara, Turkey, 06490

Status
Terminated
 
Locations

Sifa University Medical Faculty

IZMIR, Turkey, 03540

Status
Terminated
 
Locations

Investigative Site

Budapest, Hungary, 1036

Status
Completed
 
Locations

Investigative Site

Sofia, Bulgaria, 1872

Status
Completed
 

Trial Design