15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific)

NCT02021370 | Completed Phase 2 DMC

• 2 other identifiers: 151412013-001193-14
• Study Type: interventional
• Target: 121
• Locations: 14 countries
• Sites: 56

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.

Conditions

Anemia; Renal Insufficiency, Chronic

Keywords

Anemia of CKD

Outcome Measures

Primary Outcomes (1)

• Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period

  Baseline and week 12 to 16

Secondary Outcomes (6)

• Change in local laboratory hemoglobin level from baseline

  Baseline up to 12 weeks

• Speed of change in hemoglobin level per unit time

  Up to 16 weeks

• Duration of treatment exposure

  Up to 16 weeks

• Number of participants with serious adverse events as a measure of safety and tolerability

  Up to 16 weeks

• Pharmacodynamics characterized by erythropoietin concentration

  Several time points up to 16 weeks

Study Arms (6)

BAY85-3934 (25mg OD)

EXPERIMENTAL

25 mg once daily (OD) of BAY85-3934 Morning: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo Evening: 3 tablets matching placebo

Drug: BAY85-3934; Drug: Placebo

BAY85-3934 (50mg OD)

EXPERIMENTAL

50 mg OD of BAY85-3934 Morning: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo Evening: 3 tablets matching placebo

Drug: BAY85-3934; Drug: Placebo

BAY85-3934 (75mg OD)

EXPERIMENTAL

75 mg OD of BAY85-3934 Morning: 3 tablets BAY85-3934 25 mg Evening: 3 tablets matching placebo

Drug: BAY85-3934; Drug: Placebo

BAY85-3934 (25mg BID)

EXPERIMENTAL

25 mg twice daily (BID) of BAY85-3934 Morning and evening: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo

Drug: BAY85-3934; Drug: Placebo

BAY85-3934 (50mg BID)

EXPERIMENTAL

50 mg BID of BAY85-3934 Morning and evening: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo

Drug: BAY85-3934; Drug: Placebo

Placebo BID

PLACEBO COMPARATOR

Placebo BID Morning and evening: 3 tablets of placebo matching BAY85-3934 25 mg

Drug: Placebo

Interventions

BAY85-3934 DRUG

25mg Tablet

BAY85-3934 (25mg BID); BAY85-3934 (25mg OD); BAY85-3934 (50mg BID); BAY85-3934 (50mg OD); BAY85-3934 (75mg OD)

Placebo DRUG

Matching placebo tablet

BAY85-3934 (25mg BID); BAY85-3934 (25mg OD); BAY85-3934 (50mg BID); BAY85-3934 (50mg OD); BAY85-3934 (75mg OD); Placebo BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (56)

Unknown Facility

Gosford, New South Wales, 2250, Australia

Location

Unknown Facility

Melbourne, Victoria, 3052, Australia

Location

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Gabrovo, 5300, Bulgaria

Location

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Lovech, 5500, Bulgaria

Location

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Montana, 3400, Bulgaria

Location

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Pazardzhik, 4400, Bulgaria

Location

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Stara Zagora, 6000, Bulgaria

Location

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Veliko Tarnovo, 5000, Bulgaria

Location

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Limoges Cedex1, 87042, France

Location

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Villingen-Schwenningen, Baden-Wurttemberg, 78052, Germany

Location

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Bonn, North Rhine-Westphalia, 53127, Germany

Location

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Düsseldorf, North Rhine-Westphalia, 40210, Germany

Location

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Halle, Saxony-Anhalt, 06097, Germany

Location

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Baja, 6500, Hungary

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Budapest, 1036, Hungary

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Pécs, 7623, Hungary

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Ashkelon, 7827804, Israel

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Hadera, 3810101, Israel

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Nahariya, 2210001, Israel

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Napoli, Campania, 80138, Italy

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Modena, Emilia-Romagna, 41100, Italy

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Cremona, Lombardy, 26100, Italy

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Pavia, Lombardy, 27100, Italy

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Livorno, Tuscany, 57023, Italy

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Kitakyushu, Fukuoka, 802-8555, Japan

Location

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Ōkawa, Fukuoka, 831-0016, Japan

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Muroran, Hokkaido, 050-0083, Japan

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Hakusan, Ishikawa-ken, 924-8588, Japan

Location

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Morioka, Iwate, 020-0066, Japan

Location

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Kamakura, Kanagawa, 247-8533, Japan

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Kuwana, Mie-ken, 511-0061, Japan

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Chiba, 260-8712, Japan

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Fukuoka, 810-8563, Japan

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Nara, 630-8581, Japan

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Bialystok, 15-540, Poland

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Malbork, 82-200, Poland

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Poznan, 61-858, Poland

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Radom, 26-610, Poland

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Szczecin, 70-111, Poland

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Żyrardów, 96-300, Poland

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Bucharest, 020475, Romania

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Constanța, 900591, Romania

Location

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Oradea, 410469, Romania

Location

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Târgu Mureş, 540103, Romania

Location

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Bucheon-si, Gyeonggido, 420-767, South Korea

Location

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Seoul, 03080, South Korea

Location

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Seoul, 156-707, South Korea

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Seoul, 156-755, South Korea

Location

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Santiago de Compostela, A Coruña, 15706, Spain

Location

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Ankara Univ. Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Baskent University Medical Faculty

Ankara, 06490, Turkey (Türkiye)

Location

Sifa University Medical Faculty

Izmir, 03540, Turkey (Türkiye)

Location

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Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

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Doncaster, South Yorkshire, DN2 5LT, United Kingdom

Location

Unknown Facility

London, SE5 9RS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36005278 DERIVED

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: December 27, 2013
• Study Start: February 10, 2014
• Primary Completion: September 15, 2015
• Study Completion: September 23, 2015
• Last Updated: September 20, 2019

Record last verified: 2019-09

Locations

GB (3); BU (6); TU (3); PL (6); KR (4); DE (4); JP (10); HU (3); AU (2); FR (1); IT (5); IL (3); RO (4); ES (2)