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

Anemia Clinical Trial

— DIALOGUE 2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021409
• Other study ID #: 15261
• Secondary ID: 2013-001192-21
• Status: Completed
• Phase: Phase 2
• Start date: January 28, 2014
• Est. completion date: November 23, 2015

Study information

• Verified date: September 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: November 23, 2015
• Est. primary completion date: October 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anemia
• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• BAY85-3934
Oral doses of BAY 85-3934 will be available in multiples of 5, 25, and 75 mg tablets

Biological:
• Darbepoetin alfa

Locations

Country	Name	City	State
Turkey	Ankara Univ. Medical Faculty	Ankara
Turkey	Baskent University Medical Faculty	Ankara
Turkey	Sifa University Medical Faculty	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Australia,  Bulgaria,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Poland,  Romania,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maintenance in hemoglobin target range (10.0 to 12.0 g/dL)		Up to 16 weeks
Secondary	Change in hemoglobin level		Baseline up to 16 weeks
Secondary	Number of patients with hemoglobin levels outside the target range		Week 12 to 16
Secondary	Dose level in the evaluation period		Week 12 to 16
Secondary	Duration of exposure on each dose level		Up to 16 weeks
Secondary	Number of subjects requiring titration of dose		Up to 16 weeks
Secondary	Number of participants with serious adverse events as a measure of safety and tolerability		Up to 16 weeks

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