check_circleStudy Completed

Anemia, Renal Insufficiency, Chronic

Bayer Identifier:

15261

ClinicalTrials.gov Identifier:

NCT02021409

EudraCT Number:

2013-001192-21

EU CT Number:

Not Available
Maintenance treatment of anemia in pre-dialysis subjects with chronic kidney disease on darbepoetin treatment versus BAY85-3934

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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
January 2014 - November 2015
Phase
Phase 2
Could I Receive a placebo
No
Products
Molidustat (BAY85-3934)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Pavia, 27100, Italy
Completed
Cremona, 26100, Italy
Withdrawn
Milano, 20132, Italy
Completed
Livorno, 57023, Italy
Completed
Reservoir, 3073, Australia
Completed
Gosford, 2250, Australia
Withdrawn
Melbourne, 3052, Australia
Withdrawn
London, United Kingdom
Completed
Cambridge, CB2 0QQ, United Kingdom
Completed
Liverpool, L7 8XP, United Kingdom
Completed
Nagano, 388-8004, Japan
Completed
Kitakyushu, 802-8555, Japan
Completed
Muroran, 050-0083, Japan
Completed
Fukuoka, 810-8563, Japan
Withdrawn
Düsseldorf, 40210, Germany
Withdrawn
Berlin, 12053, Germany
Completed
Pecs, 7624, Hungary
Withdrawn
Debrecen, 4032, Hungary
Completed
Esztergom, 2500, Hungary
Completed
Baja, 6500, Hungary
Completed
Targu-Mures, 540103, Romania
Completed
Oradea, 410469, Romania
Withdrawn
Bucharest, 050098, Romania
Withdrawn
Brasov, 500152, Romania
Completed
Pazardjik, 4400, Bulgaria
Withdrawn
Veliko Tarnovo, 5000, Bulgaria
Completed
Montana, 3400, Bulgaria
Completed
Lovech, 5500, Bulgaria
Withdrawn
Sofia, 1431, Bulgaria
Withdrawn
Sofia, 1527, Bulgaria
Completed
Bucheon-si, 420-767, Korea, Republic Of
Withdrawn
Chieti, 66013, Italy
Completed
Lecco, 23900, Italy
Completed
Bucharest, 020475, Romania
Completed
Fujisawa, 251-8550, Japan
Withdrawn
Kamakura, 247-8533, Japan
Completed
Bucharest, 010731, Romania
Completed
L'Hospitalet de Llobregat, 08907, Spain
Withdrawn
Alicante, 03010, Spain
Withdrawn
Córdoba, 14004, Spain
Withdrawn
Madrid, 28041, Spain
Completed
Madrid, 28007, Spain
Completed
San Sebastián de los Reyes, 28702, Spain
Withdrawn
Burgas, 8000, Bulgaria
Completed
PIERRE BENITE CEDEX, 69495, France
Withdrawn
PARIS CEDEX 15, 75908, France
Completed
GRENOBLE CEDEX 9, 38043, France
Withdrawn
PERPIGNAN CEDEX 9, 66046, France
Withdrawn
MARSEILLE CEDEX 5, 13385, France
Withdrawn
REIMS cedex, 51092, France
Withdrawn
Barcelona, 08035, Spain
Withdrawn
Barcelona, 08036, Spain
Completed
Kuwana, 511-0061, Japan
Completed
Kaposvar, 7400, Hungary
Completed
Szigetvar, 7900, Hungary
Withdrawn
Poznan, 61-858, Poland
Completed
Radom, 26-610, Poland
Completed
Okawa, 831-0016, Japan
Completed
Stara Zagora, 6000, Bulgaria
Withdrawn
Gabrovo, 5300, Bulgaria
Withdrawn
Wuppertal, 42283, Germany
Completed
Bialystok, 15-540, Poland
Completed
Chiba, 260-8712, Japan
Withdrawn
Valenciennes, 59300, France
Withdrawn
LIMOGES Cedex1, 87042, France
Withdrawn
BREST CEDEX, 29609, France
Completed
Bonn, 53127, Germany
Withdrawn
Halle (Saale), 06097, Germany
Withdrawn
Nara, 630-8581, Japan
Completed
Morioka, 020-0066, Japan
Withdrawn
Milano, 20162, Italy
Completed
Napoli, 80138, Italy
Completed
Kfar Saba, 4428164, Israel
Completed
Ashkelon, 7827804, Israel
Completed
Dobrich, 9300, Bulgaria
Completed
Brescia, 25123, Italy
Completed
Hadera, 3810101, Israel
Completed
Nahariya, 2210001, Israel
Withdrawn
Jerusalem, 9112001, Israel
Terminated
Ankara Univ. Medical FacultyAnkara, 06100, Turkey
Terminated
Baskent University Medical FacultyAnkara, 06490, Turkey
Terminated
Sifa University Medical FacultyIZMIR, 03540, Turkey
Withdrawn
Santiago de Compostela, 15706, Spain
Withdrawn
Stoke-on-Trent, ST4 6QG, United Kingdom
Withdrawn
Brighton, BN2 5BE, United Kingdom
Withdrawn
Salford, M6 8HD, United Kingdom
Withdrawn
Leeds, WF3 4PX, United Kingdom
Withdrawn
Dundee, DD1 9SY, United Kingdom
Completed
Budapest, 1036, Hungary
Completed
Sofia, 1872, Bulgaria
Withdrawn
Karlovo, 4300, Bulgaria

Primary Outcome

  • Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
    date_rangeTime Frame:
    Baseline and week 12 to 16
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Maintenance in hemoglobin target range (10.0 to 12.0 g/dL)
    date_rangeTime Frame:
    Up to 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Change in hemoglobin level
    date_rangeTime Frame:
    Baseline up to 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients with hemoglobin levels outside the target range
    date_rangeTime Frame:
    Week 12 to 16
    enhanced_encryption
    Safety Issue:
    No
  • Dose level in the evaluation period
    date_rangeTime Frame:
    Week 12 to 16
    enhanced_encryption
    Safety Issue:
    No
  • Duration of exposure on each dose level
    date_rangeTime Frame:
    Up to 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Number of subjects requiring titration of dose
    date_rangeTime Frame:
    Up to 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with serious adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 16 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

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