Anaemia of Chronic Kidney Disease MedDRA version: 18.1 Level: LLT Classification code 10058132 Term: Renal anemia System Organ Class: 100000004851
Conditions
Interventions
Product Name: BAY 85-3934
Product Code: BAY 85-3934 coated tablets 5mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: molidustat
CAS Number: 1154028-82-6
Current Sponsor code: BAY 85-393
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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 (including, but not limited to, sickle cell disease, beta thalassemia, and thalassemia major) which may be the primary cause of anemia - 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) - 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) - 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 the initial screening visit - Sustained, poorly controlled arterial hypertension or hypotension at screening, defined as a mean BP = 180/110 mmHg or systolic BP 110 bpm, atrial flutter, prolonged QT > 500 msec, third degree atrioventricular [AV] block if not treated with a pacemaker)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of 16 weeks of titrated dose treatment with BAY 85-3934 versus darbepoetin alfa (hereafter called darbepoetin) as measured by haemoglobin (Hb) levels during the last 4 weeks of treatment (evaluation period).;Secondary Objective: • Evaluate the safety and tolerability of 16 weeks of treatment with BAY 85-3934 when administered as a titrated dose versus darbepoetin. • Evaluate the pharmacodynamics of BAY 85-3934 when administered as a titrated dose for 16 weeks. • Evaluate the pharmacokinetics of BAY 85-3934 and optionally its metabolite, M-1, when administered as a titrated dose for 16 weeks. The exploratory objective is to investigate selected parameters of kidney function and chronic kidney disease (CKD) progression, as well as parameters of iron metabolism and patient-reported outcomes (PROs). ;Primary end point(s): Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period.;Timepoint(s) of evaluation of this end point: Baseline and week 12 to 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Maintenance in hemoglobin target range (10.0 to 12.0 g/dL) 2) Change in hemoglobin level 3) Number of patients with hemoglobin levels outside the target range 4) Treatment exposure 5) Number of subjects requiring titration of dose 6) Number of participants with serious adverse events as a measure of safety and tolerability;Timepoint(s) of evaluation of this end point: 1) Up to 16 weeks 2) Baseline up to 16 weeks 3) Week 12 to 16 4) Up to 16 weeks 5) Up to 16 weeks 6) Up to 16 weeks | — |
Countries
Australia, Bulgaria, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Poland, Romania, Spain, United Kingdom
Contacts
Public ContactBayer Clinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed