Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934

NCT ID: NCT02021409

Last Updated: 2019-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-28
• Study Completion Date: 2015-11-23

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 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.

Conditions

Anemia; Renal Insufficiency, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BAY85-3934 (25mg)

Fixed starting dose of 25 mg of BAY85-3934 oral tablet (once daily dose) titrated at the scheduled dose control visits. Titration occuring every 4-weeks will be based on the subject's hemoglobin (Hb) response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100, and 150 mg once daily.

Group Type: EXPERIMENTAL

BAY85-3934

Intervention Type: DRUG

Oral doses of BAY 85-3934 will be available in multiples of 5, 25, and 75 mg tablets

BAY85-3934 (50mg)

Fixed starting dose of 50 mg of BAY85-3934 oral tablet (once daily dose) titrated at the scheduled dose control visits. Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100, and 150 mg once daily.

Group Type: EXPERIMENTAL

BAY85-3934

Intervention Type: DRUG

Oral doses of BAY 85-3934 will be available in multiples of 5, 25, and 75 mg tablets

BAY85-3934 (75mg)

Fixed starting doses of 75 mg of BAY85-3934 oral tablet (once daily dose) titrated at the scheduled dose control visits. Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100, and 150 mg once daily.

Group Type: EXPERIMENTAL

BAY85-3934

Intervention Type: DRUG

Oral doses of BAY 85-3934 will be available in multiples of 5, 25, and 75 mg tablets

Darbepoetin alfa

Darbepoetin (intravenous or subcutaneous) will be administered according to the local label and titrated at the scheduled dose control visits. Titration will be based on the subject's Hb response and tolerability of the prior dose.

Group Type: ACTIVE_COMPARATOR

Darbepoetin alfa

Intervention Type: BIOLOGICAL

Interventions

BAY85-3934

Oral doses of BAY 85-3934 will be available in multiples of 5, 25, and 75 mg tablets

Intervention Type: DRUG

Darbepoetin alfa

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Gosford, New South Wales, Australia

Reservoir, Victoria, Australia

Dobrich, , Bulgaria

Lovech, , Bulgaria

Montana, , Bulgaria

Pazardzhik, , Bulgaria

Sofia, , Bulgaria

Stara Zagora, , Bulgaria

Grenoble, , France

Pierre-Bénite, , France

Bonn, North Rhine-Westphalia, Germany

Baja, , Hungary

Budapest, , Hungary

Esztergom, , Hungary

Kaposvár, , Hungary

Pécs, , Hungary

Szigetvár, , Hungary

Ashkelon, , Israel

Hadera, , Israel

Kfar Saba, , Israel

Nahariya, , Israel

Napoli, Campania, Italy

Brescia, Lombardy, Italy

Cremona, Lombardy, Italy

Lecco, Lombardy, Italy

Pavia, Lombardy, Italy

Livorno, Tuscany, Italy

Kitakyushu, Fukuoka, Japan

Ōkawa, Fukuoka, Japan

Muroran, Hokkaido, Japan

Morioka, Iwate, Japan

Fujisawa, Kanagawa, Japan

Kuwana, Mie-ken, Japan

Chiba, , Japan

Fukuoka, , Japan

Nagano, , Japan

Bialystok, , Poland

Radom, , Poland

Bucharest, , Romania

Bucharest, , Romania

Oradea, , Romania

Târgu Mureş, , Romania

Bucheon-si, Gyeonggido, South Korea

L'Hospitalet de Llobregat, Barcelona, Spain

San Sebastián de los Reyes, Madrid, Spain

Madrid, , Spain

Ankara Univ. Medical Faculty

Ankara, , Turkey (Türkiye)

Baskent University Medical Faculty

Ankara, , Turkey (Türkiye)

Sifa University Medical Faculty

Izmir, , Turkey (Türkiye)

Cambridge, Cambridgeshire, United Kingdom

Liverpool, , United Kingdom

Countries

Australia; Bulgaria; France; Germany; Hungary; Israel; Italy; Japan; Poland; Romania; South Korea; Spain; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: DERIVED

PMID: 36005278 (View on PubMed)

Related Links

https://www.clinicaltrialsregister.eu/

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http://clinicaltrials.bayer.com/

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Other Identifiers

2013-001192-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15261

Identifier Type: -

Identifier Source: org_study_id