Trial Condition(s):

Anemia, Renal Insufficiency, Chronic

Long-term pre-dialysis extension in Europe and Asia Pacific (DIALOGUE 3)

Bayer Identifier:

15653

ClinicalTrials.gov Identifier:

NCT02055482

EudraCT Number:

2013-001190-24

EU CT Number:

Not Available

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 extension 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 extension study will enroll up to 240 patients at multiple locations in Europe, Asia and Australia. Patients who participated in Studies 15141 or 15261 may be eligible to take part in the extension study. The study consists of the Haemoglobin (Hb) Stabilisation Phase and the Main Phase. The Hb Stabilisation Phase involves up to 10 study visits scheduled over 16 weeks. The Main Phase will last for at least 6 months and up to a maximum of 36 months, with visits every 4 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.
This study will include subjects who either completed the treatment period in their respective Phase 2 parent study (i.e., Study 15141 or Study 15261) or experienced a stopping event in the fixed dose parent study (Study 15141). As Study 15141 is a double-blind study, subjects will be unblinded as per the Study 15141 protocol prior to entry into the extension study.

Inclusion Criteria
- Men who agree to use adequate contraception when sexually active or women without childbearing potential
- Not on dialysis at study entry
- Serum ferritin levels ≥ 100 μg/L and < 1000 μg/L or transferrin saturation ≥ 20% 
- Inclusion criteria for inclusion into the Hb Stabilization (HbS) Phase: Requires Hb stabilization (at 10.0 to 12..0g/dL for a minimum of 4 weeks) as follows: Received BAY 85-3934 and reached a stopping event in Study 15141 or received placebo and reached a stopping event in Study 15141 or completed 16 weeks of treatment with BAY 85-3934 in Study 15141or 15261 but had mean Hb during the evaluation period outside the target range of 10.0 to 12.0 g/dL, or Completed 16 weeks of treatment with placebo in Study 15141 and was re-assessed at 4 weeks after end of study as eligible for Study 15653 (this study)
- Inclusion criteria for inclusion into the Main Phase: Mean Hb concentration of 10.0 to 12.0 g/dL who completed 16 weeks of treatment (BAY85-3934 arm) in Study 15141, or completed 16 weeks of treatment (BAY-3934 or darbepoetin arm)in study 15261 without a dose suspension lasting > 6 consecutive weeks, or mean Hb concentration of 10.0 to 12.0g/dL during the HbS phase of Study 15653 for a minimum of 4 weeks after visit 3.
Exclusion Criteria
- A scheduled kidney transplant or any other organ transplant within the next 6 months (being on a waiting list does not exclude the subject)
- Red blood cell (RBC) containing transfusion within the 8 weeks before baseline
- Phosphodiesterase type 5 (PDE5) inhibitor (e.g., sildenafil, vardenafil, tadalafil) or nitrates
- Sustained, poorly controlled arterial hypertension or hypotension at baseline, defined as blood pressure ≥ 180/110 mmHg or systolic blood pressure < 95 mmHg, respectively
- Severe rhythm or conduction disorders (e.g., heart rate [HR] < 50 or > 110 bpm, atrial flutter, prolonged QT > 500 msec, second or third degree atrioventricular [AV] block), if not reacted with a pace marker)
- New York Heart Association Class III or IV congestive heart failure
- Severe hepatic insufficiency (defined as alanine aminotransferase [ALT], aspartate aminotransferase [AST]>3x the upper limit of normal [ULN], total bilirubin > 2 mg/dL, or Child Pugh B or C) or active hepatitis, in the investigator’s opinion
- An ongoing serious adverse event (SAE) from Study 15141 or Study 15261 that is assessed as related to study drug

Trial Summary

Enrollment Goal
166
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Molidustat (BAY85-3934)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Düsseldorf, Germany, 40210

Status
Completed
Locations

Investigative Site

Pirmasens, Germany, 66953

Status
Terminated
Locations

Investigative Site

Reservoir, Australia, 3073

Status
Terminated
Locations

Investigative Site

Gosford, Australia, 2250

Status
Terminated
Locations

Investigative Site

Melbourne, Australia, 3052

Status
Terminated
Locations

Investigative Site

Berlin, Germany, 12053

Status
Terminated
Locations

Investigative Site

London, United Kingdom

Status
Terminated
Locations

Investigative Site

Cambridge, United Kingdom, CB2 0QQ

Status
Terminated
Locations

Investigative Site

Liverpool, United Kingdom, L7 8XP

Status
Terminated
Locations

Investigative Site

London, United Kingdom, SE5 9RS

Status
Completed
Locations

Investigative Site

Doncaster, United Kingdom, DN2 5LT

Status
Completed
Locations

Investigative Site

Pavia, Italy, 27100

Status
Completed
Locations

Investigative Site

Cremona, Italy, 26100

Status
Completed
Locations

Investigative Site

Milano, Italy, 20132

Status
Terminated
Locations

Investigative Site

Livorno, Italy, 57023

Status
Completed
Locations

Investigative Site

Modena, Italy, 41100

Status
Terminated
Locations

Investigative Site

Pecs, Hungary, 7624

Status
Completed
Locations

Investigative Site

Debrecen, Hungary, 4032

Status
Terminated
Locations

Investigative Site

Esztergom, Hungary, 2500

Status
Completed
Locations

Investigative Site

Baja, Hungary, 6500

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
Locations

Investigative Site

Targu-Mures, Romania, 540103

Status
Terminated
Locations

Investigative Site

Oradea, Romania, 410469

Status
Completed
Locations

Investigative Site

Bucharest, Romania, 050098

Status
Terminated
Locations

Investigative Site

Brasov, Romania, 500152

Status
Terminated
Locations

Investigative Site

Pazardjik, Bulgaria, 4400

Status
Terminated
Locations

Investigative Site

Veliko Tarnovo, Bulgaria, 5000

Status
Completed
Locations

Investigative Site

Montana, Bulgaria, 3400

Status
Completed
Locations

Investigative Site

Lovech, Bulgaria, 5500

Status
Completed
Locations

Investigative Site

Sofia, Bulgaria, 1431

Status
Terminated
Locations

Investigative Site

Sofia, Bulgaria, 1527

Status
Terminated
Locations

Investigative Site

Bucheon-si, South Korea, 420-767

Status
Completed
Locations

Investigative Site

Chieti, Italy, 66013

Status
Terminated
Locations

Investigative Site

Lecco, Italy, 23900

Status
Completed
Locations

Investigative Site

Bucharest, Romania, 020475

Status
Completed
Locations

Investigative Site

Fujisawa, Japan, 251-8550

Status
Terminated
Locations

Investigative Site

Kamakura, Japan, 247-8533

Status
Terminated
Locations

Investigative Site

Bucharest, Romania, 010731

Status
Completed
Locations

Investigative Site

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
Locations

Investigative Site

Alicante, Spain, 03010

Status
Terminated
Locations

Investigative Site

Córdoba, Spain, 14004

Status
Terminated
Locations

Investigative Site

Madrid, Spain, 28041

Status
Terminated
Locations

Investigative Site

Madrid, Spain, 28007

Status
Completed
Locations

Investigative Site

San Sebastián de los Reyes, Spain, 28702

Status
Completed
Locations

Investigative Site

Sofia, Bulgaria, 1309

Status
Terminated
Locations

Investigative Site

Burgas, Bulgaria, 8000

Status
Terminated
Locations

Investigative Site

PIERRE BENITE CEDEX, France, 69495

Status
Completed
Locations

Investigative Site

GRENOBLE CEDEX 9, France, 38043

Status
Completed
Locations

Investigative Site

Barcelona, Spain, 08035

Status
Terminated
Locations

Investigative Site

Barcelona, Spain, 08036

Status
Terminated
Locations

Investigative Site

Kuwana, Japan, 511-0061

Status
Completed
Locations

Investigative Site

Constanta, Romania, 900591

Status
Completed
Locations

Investigative Site

Kaposvar, Hungary, 7400

Status
Completed
Locations

Investigative Site

Szigetvar, Hungary, 7900

Status
Terminated
Locations

Investigative Site

Poznan, Poland, 61-858

Status
Completed
Locations

Investigative Site

Radom, Poland, 26-610

Status
Completed
Locations

Investigative Site

Okawa, Japan, 831-0016

Status
Completed
Locations

Investigative Site

Stara Zagora, Bulgaria, 6000

Status
Completed
Locations

Investigative Site

Gabrovo, Bulgaria, 5300

Status
Terminated
Locations

Investigative Site

Wuppertal, Germany, 42283

Status
Terminated
Locations

Investigative Site

Bialystok, Poland, 15-540

Status
Completed
Locations

Investigative Site

Chiba, Japan, 260-8712

Status
Completed
Locations

Investigative Site

Valenciennes, France, 59300

Status
Terminated
Locations

Investigative Site

LIMOGES Cedex1, France, 87042

Status
Completed
Locations

Investigative Site

BREST CEDEX, France, 29609

Status
Terminated
Locations

Investigative Site

Szczecin, Poland, 70-111

Status
Completed
Locations

Investigative Site

Bonn, Germany, 53127

Status
Terminated
Locations

Investigative Site

Seoul, South Korea, 156-707

Status
Completed
Locations

Investigative Site

Seoul, South Korea, 156-755

Status
Completed
Locations

Investigative Site

Seoul, South Korea, 03080

Status
Completed
Locations

Investigative Site

Zyrardow, Poland, 96-300

Status
Terminated
Locations

Investigative Site

Halle (Saale), Germany, 06097

Status
Terminated
Locations

Investigative Site

Hakusan, Japan, 924-8588

Status
Completed
Locations

Investigative Site

Nara, Japan, 631-0846

Status
Completed
Locations

Investigative Site

Morioka, Japan, 020-0066

Status
Completed
Locations

Investigative Site

Milano, Italy, 20162

Status
Terminated
Locations

Investigative Site

Napoli, Italy, 80138

Status
Completed
Locations

Investigative Site

Kfar Saba, Israel, 4428164

Status
Terminated
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
Terminated
Locations

Investigative Site

Jerusalem, Israel, 9112001

Status
Terminated
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

Santiago de Compostela, Spain, 15706

Status
Terminated
Locations

Investigative Site

Brighton, United Kingdom, BN2 5BE

Status
Terminated
Locations

Investigative Site

Salford, United Kingdom, M5 5AP

Status
Terminated
Locations

Investigative Site

Leeds, United Kingdom, WF3 4PX

Status
Terminated
Locations

Investigative Site

Dundee, United Kingdom, DD1 9SY

Status
Terminated
Locations

Investigative Site

Budapest, Hungary, 1036

Status
Completed
Locations

Investigative Site

Sofia, Bulgaria, 1872

Status
Completed
Locations

Investigative Site

Karlovo, Bulgaria, 4300

Status
Terminated
Locations

Investigative Site

Villingen-Schwenningen, Germany, 78052

Status
Completed
Locations

Investigative Site

Chorley, United Kingdom, PR7 7NA

Status
Terminated
Locations

Investigative Site

Hexham, United Kingdom, NE46 1QJ

Status
Terminated
Locations

Investigative Site

Manchester, United Kingdom, M15 6SX

Status
Terminated
Locations

Investigative Site

Glasgow, United Kingdom, G20 OSP

Status
Terminated
Locations

Investigative Site

Liverpool, United Kingdom, L22 0LG

Status
Terminated
Locations

Investigative Site

Reading, United Kingdom, RG2 0TG

Status
Terminated

Trial Design