Clinical trial NCT02021370: 15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific)
Official title: A Randomized, Placebo-controlled, Double-blind, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of 5 Fixed Doses of BAY85-3934 Administered Orally in the Correction of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease Not Currently Treated With Erythropoiesis-stimulating Agent in Europe and Asia Pacific
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
Renal Insufficiency, Chronic
Keywords: Anemia of CKD
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-12-27
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 14 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 5 hospitals in the UK. Bayer HealthCare AG is funding this research.


Eligibility criteria: Inclusion Criteria:

* Women without childbearing potential
* Male or female subjects ≥ 18 years of age with anemia of chronic kidney disease (CKD) at screening
* Estimated glomerular filtration rate of \< 60 mL/min/1.73 m2 (Modification of Diet in Renal Disease \[MDRD\] 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)
* Not treated with any erythropoiesis-stimulating agent (ESA) within 8 weeks before randomization
* Mean screening Hb concentration \</= 10.5 g/dL
* Body weight of 45 kg to 125 kg, inclusive, at screening

Exclusion Criteria:

* Subjects with significant acute or chronic bleeding, such as overt gastrointestinal bleeding
* Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
* 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
* Subjects treated with any ESA within the 8 weeks before randomization
* Red blood cell (RBC) containing transfusion within the 8 weeks before randomization
* History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within the last 6 months from initial screening visit
* Severe rhythm or conduction disorders (e.g., HR \< 50 or \> 110 bpm, atrial flutter, prolonged QT \> 500 msec, third degree atrioventricular \[AV\] block)
* New York Heart Association Class III or IV congestive heart failure
* Severe hepatic insufficiency (defined as alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \> 3 x the upper limit of normal \[ULN\], total bilirubin \> 2 mg/dL, or Child-Pugh B and C) or active hepatitis, in the investigator's opinion

Primary outcomes:
measure: Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
timeFrame: Baseline and week 12 to 16
Secondary outcomes:
measure: Change in local laboratory hemoglobin level from baseline
timeFrame: Baseline up to 12 weeks
measure: Speed of change in hemoglobin level per unit time
timeFrame: Up to 16 weeks
measure: Duration of treatment exposure
timeFrame: Up to 16 weeks
measure: Number of participants with serious adverse events as a measure of safety and tolerability
timeFrame: Up to 16 weeks
measure: Pharmacodynamics characterized by erythropoietin concentration
timeFrame: Several time points up to 16 weeks
measure: Pharmacodynamics characterized by reticulocyte count
timeFrame: Several time points up to 16 weeks
Other outcomes:
Locations:
city: Gosford
country: Australia
state: New South Wales
city: Melbourne
country: Australia
state: Victoria
city: Gabrovo
country: Bulgaria
city: Lovech
country: Bulgaria
city: Montana
country: Bulgaria
city: Pazardjik
country: Bulgaria
city: Stara Zagora
country: Bulgaria
city: Veliko Tarnovo
country: Bulgaria
city: Limoges Cedex1
country: France
city: Villingen-Schwenningen
country: Germany
state: Baden-Württemberg
city: Bonn
country: Germany
state: Nordrhein-Westfalen
city: Düsseldorf
country: Germany
state: Nordrhein-Westfalen
city: Halle (Saale)
country: Germany
state: Sachsen-Anhalt
city: Baja
country: Hungary
city: Budapest
country: Hungary
city: Pecs
country: Hungary
city: Ashkelon
country: Israel
city: Hadera
country: Israel
city: Nahariya
country: Israel
city: Napoli
country: Italy
state: Campania
city: Modena
country: Italy
state: Emilia-Romagna
city: Cremona
country: Italy
state: Lombardia
city: Pavia
country: Italy
state: Lombardia
city: Livorno
country: Italy
state: Toscana
city: Kitakyushu
country: Japan
state: Fukuoka
city: Okawa
country: Japan
state: Fukuoka
city: Muroran
country: Japan
state: Hokkaido
city: Hakusan
country: Japan
state: Ishikawa
city: Morioka
country: Japan
state: Iwate
city: Kamakura
country: Japan
state: Kanagawa
city: Kuwana
country: Japan
state: Mie
city: Chiba
country: Japan
city: Fukuoka
country: Japan
city: Nara
country: Japan
city: Bucheon-si
country: Korea, Republic of
state: Gyeonggido
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Bialystok
country: Poland
city: Malbork
country: Poland
city: Poznan
country: Poland
city: Radom
country: Poland
city: Szczecin
country: Poland
city: Zyrardow
country: Poland
city: Bucharest
country: Romania
city: Constanta
country: Romania
city: Oradea
country: Romania
city: Targu-Mures
country: Romania
city: Santiago de Compostela
country: Spain
state: A Coruña
city: L'Hospitalet de Llobregat
country: Spain
state: Barcelona
city: Ankara
country: Turkey
facility: Ankara Univ. Medical Faculty
city: Ankara
country: Turkey
facility: Baskent University Medical Faculty
city: Izmir
country: Turkey
facility: Sifa University Medical Faculty
city: Cambridge
country: United Kingdom
state: Cambridgeshire
city: Doncaster
country: United Kingdom
state: South Yorkshire
city: London
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.