Anaemia of Chronic Kidney Disease MedDRA version: 18.0 Level: LLT Classification code 10058123 Term: Renal anaemia System Organ Class: 100000004851
Conditions
Interventions
Product Name: BAY 85-3934
Product Code: BAY 85-3934 coated tablet 25mg
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: • Women without childbearing potential • Male or female subjects = 18 years of age with anemia of CKD at screening • Estimated glomerular filtration rate 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 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 agerelated macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation) • 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) • Subjects treated with any ESA within the 8 weeks before randomization - Subjects known to be hyporesponsive (e.g., Hb levels 110 bpm, atrial flutter , prolonged QT > 500 msec, third degree atrioventricular [AV] block if not treated with a pacemaker • Women of childbearing potential or pregnant or breast feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy for up to 16 weeks of fixed dose treatment with BAY 85-3934 versus placebo as measured by haemoglobin (Hb) levels.;Secondary Objective: To evaluate the safety and tolerability of BAY 85-3934 when administered as a fixed dose for up to 16 weeks versus placebo. To evaluate the pharmacodynamics (PD) of BAY 85-3934 when administered as a fixed dose for up to 16 weeks. To evaluate the pharmacokinetics (PK) of BAY 85-3934 and optionally, its metabolite M-1, when administered as a fixed dose for up to 16 weeks. To investigate selected parameters of kidney function and chronic kidney disease (CKD) progression as well as parameters of iron metabolism and patient reported outcomes (PRO). ;Primary end point(s): 1) Change in local laboratory haemoglobin level from baseline to the average during the last 4 weeks treatment period;Timepoint(s) of evaluation of this end point: 1) Baseline and week 12 to 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Change in local laboratory haemoglobin level from baseline 2) Speed of change in haemoglobin level per unit time 3) Treatment exposure (Duration) 4) Number of participants with adjudicated serious adverse events SAEs): death, and SAEs of the following events: severe arrhythmias; thromboembolic events (excluding hemodialysis vascular access events: arteriovenous shunt / fistula and arteriovenous graft events); syncope; symptomatic hypotension; and heart failure 5) Pharmacodynamics characterized by erythropoietin concentration 6) Pharmacodynamics characterized by reticulocyte count;Timepoint(s) of evaluation of this end point: 1) Baseline up to 12 weeks 2) Up to 16 weeks 3) Up to 16 weeks 4) Up to 16 weeks 5) Several time points up to 16 weeks 6) Several time points up to 16 weeks | — |
Countries
Australia, Bulgaria, 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