A clinical trial to investigate if different doses of BAY 85-3934 are safe and effective in patients with anaemia due to chronic kidney disease, who have not received any previous treatment to help produce red blood cells and are not undergoing dialysis treatment.
- Conditions
- Anaemia of Chronic Kidney DiseaseMedDRA version: 16.0Level: LLTClassification code 10058123Term: Renal anaemiaSystem Organ Class: 100000004851Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2013-001193-14-IT
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
• Men who agree to use adequate contraception when sexually active or women without childbearing potential
• Male or female subjects = 18 years of age with anemia of CKD at screening
• Estimated glomerular filtration rate of < 60 mL/min/1.73 m2 (Modification of Diet in Renal Disease [MDRD] 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)
• Not treated with any ESA within 8 weeks before randomization
• Mean screening Hb concentration < 10.0 g/dL
• Body weight of 45 kg to 125 kg, inclusive, at screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
• Subjects with significant acute or chronic bleeding, such as overt gastrointestinal bleeding
• Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
• 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
• Subjects treated with any ESA within the 8 weeks before randomization
• Red blood cell (RBC) containing transfusion within the 8 weeks before randomization
• 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 initial screening visit
• Severe rhythm or conduction disorders (e.g., HR < 50 or > 110 bpm, atrial fibrillation or flutter, prolonged QT > 500 msec, second or third degree atrioventricular [AV] block)
• New York Heart Association Class III or IV congestive heart failure
• Severe hepatic insufficiency (defined as alanine aminotransferase [ALT], aspartate aminotransferase [AST], or gamma glutamyl transferase [GGT] > 3 x the upper limit of normal [ULN], total bilirubin > 2 mg/dL, or Child-Pugh B and C) or active hepatitis, in the investigator’s opinion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;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 Objective: To evaluate the safety and tolerability of BAY 85-3934 when administered as a fixed dose for up to 16 weeks versus placebo.<br><br>To evaluate the pharmacodynamics (PD) of BAY 85-3934 when administered as a fixed dose for up to 16 weeks.<br><br>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.<br><br>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).<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Change in local laboratory haemoglobin level from baseline <br><br>2) Speed of change in haemoglobin level per unit time<br><br>3) Treatment exposure (Duration)<br><br>4) Number of participants with serious adverse events as a measure of safety and tolerability<br><br>5) Pharmacodynamics characterized by erythropoietin concentration<br><br>6) Pharmacodynamics characterized by reticulocyte count;Timepoint(s) of evaluation of this end point: 1) Baseline up to 12 weeks<br><br>2) Up to 16 weeks<br><br>3) Up to 16 weeks<br><br>4) Up to 16 weeks<br><br>5) Several time points up to 16 weeks<br><br>6) Several time points up to 16 weeks