Long-term Pre-dialysis Extension in Europe and Asia Pacific

NCT02055482 | Completed Phase 2 DMC

• 2 other identifiers: 156532013-001190-24
• Study Type: interventional
• Target: 166
• Locations: 14 countries
• Sites: 105

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 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.

Conditions

Anemia; Renal Insufficiency, Chronic

Keywords

Anemia on CKD

Outcome Measures

Primary Outcomes (3)

• Change in local laboratory hemoglobin level from baseline

  Baseline up to 36 months

• Number of participants with serious adverse events (SAEs) and adjucated adverse events as a measure of safety and tolerability

  Up to 36 months

• Number of participants with liver function-related AEs including abnormal liver function tests and any hospitalization

  Up to 36 months

Secondary Outcomes (14)

• Time within hemoglobin target range (10.0 to 12.0 g/dL)

  Up to 36 months

• Duration of treatment exposure

  Up to 36 months

• Number of subjects requiring titration of dose

  Up to 36 months

• Change of reticulocyte count from baseline of this study

  Baseline up to 36 months

• Change of red blood cell count from baseline of this study

  Baseline up to 36 months

Other Outcomes (4)

• Change of reticulocyte count from baseline of study 15141 or 15261

  Baseline up to 36 months

• Change of red blood cell count from baseline of study 15141 or 15261

  Baseline up to 36 months

• Change of hematocrit from baseline of study 15141 or 15261

  Baseline up to 36 months

Study Arms (2)

BAY85-3934

EXPERIMENTAL

Drug: Molidustat (BAY85-3934)

Darbepoetin

ACTIVE COMPARATOR

Biological: Darbepoetin

Interventions

Molidustat (BAY85-3934) DRUG

BAY85-3934 will be titrated at the scheduled dose control visits to maintain the Hb in the target range of 10.0 to 12.0 g/dL. Available doses include 15, 25, 50, 75, 100, and 150 mg/day OD. Treatment will be for minimum of 6 months to up to a maximum of 36 months.

BAY85-3934

Darbepoetin BIOLOGICAL

Darbepoetin will be administered according to the local label and titrated at the scheduled dose by intravenous injection. Treatment will be for a minimum of 6 months to up to a maximum of 36 months.

Darbepoetin

Eligibility Criteria

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

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (105)

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Gosford, New South Wales, 2250, Australia

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Melbourne, Victoria, 3052, Australia

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Reservoir, 3073, Australia

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Burgas, 8000, Bulgaria

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Dobrich, 9300, Bulgaria

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Gabrovo, 5300, Bulgaria

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Karlovo, 4300, Bulgaria

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Lovech, 5500, Bulgaria

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Montana, 3400, Bulgaria

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Pazardzhik, 4400, Bulgaria

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Sofia, 1309, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1527, Bulgaria

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Sofia, 1872, Bulgaria

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Stara Zagora, 6000, Bulgaria

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Veliko Tarnovo, 5000, Bulgaria

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Brest, 29609, France

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Grenoble, 38043, France

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Limoges Cedex1, 87042, France

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Pierre-Bénite, 69495, France

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Valenciennes, 59300, France

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Pirmasens, Baden-Wurttemberg, 66953, Germany

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Villingen-Schwenningen, Baden-Wurttemberg, 78052, Germany

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Bonn, North Rhine-Westphalia, 53127, Germany

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Düsseldorf, North Rhine-Westphalia, 40210, Germany

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Halle, Saxony-Anhalt, 06097, Germany

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Berlin, 12053, Germany

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Wuppertal, 42283, Germany

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Baja, 6500, Hungary

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Budapest, 1036, Hungary

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Debrecen, 4032, Hungary

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Esztergom, 2500, Hungary

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Kaposvár, 7400, Hungary

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Pécs, 7624, Hungary

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Szigetvár, 7900, Hungary

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Ashkelon, 7827804, Israel

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Hadera, 3810101, Israel

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Jerusalem, 9112001, Israel

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Kfar Saba, 4428164, Israel

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Nahariya, 2210001, Israel

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Chieti, Abruzzo, 66013, Italy

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Napoli, Campania, 80138, Italy

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Modena, Emilia-Romagna, 41100, Italy

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Brescia, Lombardy, 25123, Italy

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Cremona, Lombardy, 26100, Italy

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Lecco, Lombardy, 23900, Italy

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Milan, Lombardy, 20132, Italy

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Milan, Lombardy, 20162, 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

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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

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Morioka, Iwate, 020-0066, Japan

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Fujisawa, Kanagawa, 251-8550, Japan

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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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Nagano, 388-8004, Japan

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Nara, 631-0846, Japan

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Bialystok, 15-540, 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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Brasov, 500152, Romania

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Bucharest, 010731, Romania

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Bucharest, 020475, Romania

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Bucharest, 050098, Romania

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Constanța, 900591, Romania

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Oradea, 410469, Romania

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Târgu Mureş, 540103, Romania

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

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Seoul, 03080, South Korea

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Seoul, 156-707, South Korea

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Seoul, 156-755, South Korea

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Santiago de Compostela, A Coruña, 15706, Spain

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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San Sebastián de los Reyes, Madrid, 28702, Spain

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Alicante, 03010, Spain

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Córdoba, 14004, Spain

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Madrid, 28007, Spain

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Madrid, 28041, Spain

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Ankara Univ. Medical Faculty

Ankara, 06100, Turkey (Türkiye)

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Baskent University Medical Faculty

Ankara, 06490, Turkey (Türkiye)

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Sifa University Medical Faculty

Izmir, 03540, Turkey (Türkiye)

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Reading, Berkshire, RG2 0TG, United Kingdom

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Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

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Dundee, Dundee City, DD1 9SY, United Kingdom

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Brighton, East Sussex, BN2 5BE, United Kingdom

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Salford, Manchester, M5 5AP, United Kingdom

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Hexham, Northumberland, NE46 1QJ, United Kingdom

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Doncaster, South Yorkshire, DN2 5LT, United Kingdom

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Leeds, West Yorkshire, WF3 4PX, United Kingdom

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Chorley, PR7 7NA, United Kingdom

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Glasgow, G20 OSP, United Kingdom

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Liverpool, L22 0LG, United Kingdom

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Liverpool, L7 8XP, United Kingdom

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London, SE5 9RS, United Kingdom

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London, United Kingdom

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Manchester, M15 6SX, United Kingdom

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Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Interventions

molidustat; Darbepoetin alfa

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

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 5, 2014
• Study Start: June 24, 2014
• Primary Completion: November 15, 2016
• Study Completion: December 12, 2016
• Last Updated: November 22, 2017

Record last verified: 2017-11

Locations

PL (5); RO (7); FR (5); BU (13); KR (4); GB (15); ES (9); IL (5); TU (3); AU (3); JP (12); DE (7); IT (10); HU (7)