check_circleStudy Completed

Anemia, Renal Insufficiency, Chronic

Bayer Identifier:

15653

ClinicalTrials.gov Identifier:

NCT02055482

EudraCT Number:

2013-001190-24

EU CT Number:

Not Available
Long-term pre-dialysis extension in Europe and Asia Pacific

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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.
  • - 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
June 2014 - December 2016
Phase
Phase 2
Could I Receive a placebo
No
Products
Molidustat (BAY85-3934)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Düsseldorf, 40210, Germany
Terminated
Pirmasens, 66953, Germany
Terminated
Reservoir, 3073, Australia
Terminated
Gosford, 2250, Australia
Terminated
Melbourne, 3052, Australia
Terminated
Berlin, 12053, Germany
Terminated
London, United Kingdom
Terminated
Cambridge, CB2 0QQ, United Kingdom
Terminated
Liverpool, L7 8XP, United Kingdom
Completed
London, SE5 9RS, United Kingdom
Completed
Doncaster, DN2 5LT, United Kingdom
Completed
Pavia, 27100, Italy
Completed
Cremona, 26100, Italy
Terminated
Milano, 20132, Italy
Completed
Livorno, 57023, Italy
Terminated
Modena, 41100, Italy
Completed
Pecs, 7624, Hungary
Terminated
Debrecen, 4032, Hungary
Completed
Esztergom, 2500, Hungary
Completed
Baja, 6500, Hungary
Completed
Nagano, 388-8004, Japan
Completed
Kitakyushu, 802-8555, Japan
Completed
Muroran, 050-0083, Japan
Completed
Fukuoka, 810-8563, Japan
Terminated
Targu-Mures, 540103, Romania
Completed
Oradea, 410469, Romania
Terminated
Bucharest, 050098, Romania
Terminated
Brasov, 500152, Romania
Terminated
Pazardjik, 4400, Bulgaria
Completed
Veliko Tarnovo, 5000, Bulgaria
Completed
Montana, 3400, Bulgaria
Completed
Lovech, 5500, Bulgaria
Terminated
Sofia, 1431, Bulgaria
Terminated
Sofia, 1527, Bulgaria
Completed
Bucheon-si, 420-767, Korea, Republic Of
Terminated
Chieti, 66013, Italy
Completed
Lecco, 23900, Italy
Completed
Bucharest, 020475, Romania
Terminated
Fujisawa, 251-8550, Japan
Terminated
Kamakura, 247-8533, Japan
Completed
Bucharest, 010731, Romania
Completed
L'Hospitalet de Llobregat, 08907, Spain
Terminated
Alicante, 03010, Spain
Terminated
Córdoba, 14004, Spain
Terminated
Madrid, 28041, Spain
Completed
Madrid, 28007, Spain
Completed
San Sebastián de los Reyes, 28702, Spain
Terminated
Sofia, 1309, Bulgaria
Terminated
Burgas, 8000, Bulgaria
Completed
PIERRE BENITE CEDEX, 69495, France
Completed
GRENOBLE CEDEX 9, 38043, France
Terminated
Barcelona, 08035, Spain
Terminated
Barcelona, 08036, Spain
Completed
Kuwana, 511-0061, Japan
Completed
Constanta, 900591, Romania
Completed
Kaposvar, 7400, Hungary
Terminated
Szigetvar, 7900, Hungary
Completed
Poznan, 61-858, Poland
Completed
Radom, 26-610, Poland
Completed
Okawa, 831-0016, Japan
Completed
Stara Zagora, 6000, Bulgaria
Terminated
Gabrovo, 5300, Bulgaria
Terminated
Wuppertal, 42283, Germany
Completed
Bialystok, 15-540, Poland
Completed
Chiba, 260-8712, Japan
Terminated
Valenciennes, 59300, France
Completed
LIMOGES Cedex1, 87042, France
Terminated
BREST CEDEX, 29609, France
Completed
Szczecin, 70-111, Poland
Terminated
Bonn, 53127, Germany
Completed
Seoul, 156-707, Korea, Republic Of
Completed
Seoul, 156-755, Korea, Republic Of
Completed
Seoul, 03080, Korea, Republic Of
Terminated
Zyrardow, 96-300, Poland
Terminated
Halle (Saale), 06097, Germany
Completed
Hakusan, 924-8588, Japan
Completed
Nara, 631-0846, Japan
Completed
Morioka, 020-0066, Japan
Terminated
Milano, 20162, Italy
Completed
Napoli, 80138, Italy
Terminated
Kfar Saba, 4428164, Israel
Completed
Ashkelon, 7827804, Israel
Completed
Dobrich, 9300, Bulgaria
Completed
Brescia, 25123, Italy
Completed
Hadera, 3810101, Israel
Terminated
Nahariya, 2210001, Israel
Terminated
Jerusalem, 9112001, Israel
Terminated
Ankara Univ. Medical FacultyAnkara, 06100, Turkey
Terminated
Baskent University Medical FacultyAnkara, 06490, Turkey
Terminated
Sifa University Medical FacultyIZMIR, 03540, Turkey
Terminated
Santiago de Compostela, 15706, Spain
Terminated
Brighton, BN2 5BE, United Kingdom
Terminated
Salford, M5 5AP, United Kingdom
Terminated
Leeds, WF3 4PX, United Kingdom
Terminated
Dundee, DD1 9SY, United Kingdom
Completed
Budapest, 1036, Hungary
Completed
Sofia, 1872, Bulgaria
Terminated
Karlovo, 4300, Bulgaria
Completed
Villingen-Schwenningen, 78052, Germany
Terminated
Chorley, PR7 7NA, United Kingdom
Terminated
Hexham, NE46 1QJ, United Kingdom
Terminated
Manchester, M15 6SX, United Kingdom
Terminated
Glasgow, G20 OSP, United Kingdom
Terminated
Liverpool, L22 0LG, United Kingdom
Terminated
Reading, RG2 0TG, United Kingdom

Primary Outcome

  • Change in local laboratory hemoglobin level from baseline
    date_rangeTime Frame:
    Baseline up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with serious adverse events (SAEs) and adjucated adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with liver function-related AEs including abnormal liver function tests and any hospitalization
    date_rangeTime Frame:
    Up to 36 months

Secondary Outcome

  • Time within hemoglobin target range (10.0 to 12.0 g/dL)
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Duration of treatment exposure
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of subjects requiring titration of dose
    date_rangeTime Frame:
    Up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Change of reticulocyte count from baseline of this study
    date_rangeTime Frame:
    Baseline up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Change of red blood cell count from baseline of this study
    date_rangeTime Frame:
    Baseline up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Change of hematocrit from baseline of this study
    date_rangeTime Frame:
    Baseline up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Change of central laboratory hemoglobin level from baseline of this study
    date_rangeTime Frame:
    Baseline up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Responders in Hb levels
    date_rangeTime Frame:
    Up to 36 months
  • Number of subjects meeting specific Hb criteria
    date_rangeTime Frame:
    Baseline up to 36 months
  • Number of subjects with Hb values >13 g/dL or having excessive Hb increase
    date_rangeTime Frame:
    Baseline up to 36 months
  • Number of participants with non-serious adverse events
    date_rangeTime Frame:
    Up to 36 months
  • Change in heart rate (HR)
    date_rangeTime Frame:
    Up to 36 months
  • Change in blood pressure (BP)
    date_rangeTime Frame:
    Up to 36 months
  • Laboratory abnormalities
    date_rangeTime Frame:
    Up to 36 months

Trial design

A controlled, parallel group, open-label, multicenter extension study to investigate efficacy and safety of oral BAY85-3934 and darbepoetin alfa comparator in the long term treatment of anemia in pre-dialysis subjects with chronic kidney disease in Europe and Asia Pacific
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer products.Click here to find information about studies related to Bayer Healthcare products conducted in Europe.