Anaemia of Chronic Kidney Disease MedDRA version: 19.0 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 5mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: molidustat
CAS Number: 1154028-82-6
Current Sponsor code: BAY 85-393
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men who agree to use adequate contraception when sexually active or women without childbearing potential - Not on dialysis at study entry - Inclusion criteria for inclusion into the haemoglobin (Hb) Stabilization (HbS) Phase Subjects who: *Received BAY 85-3934 or placebo in Study 15141 and reached astopping event, or * Completed 16 weeks of treatment with BAY 85-3934 in Study 15141 or 15261 but had a mean Hb from the evaluation period outside the target range of 10.0 to 12.0 g/dL, or * Completed 16 weeks of treatment with placebo in Study 15141 and is re-assessed within 4 weeks after EOT visit as eligible for the HbS Phase of Study 15653 (this study) - Inclusion criteria for inclusion into the Main Phase: • Mean Hb concentration at 10.0 to 12.0 g/dL during the evaluation period of parent study for subjects who: * Completed 16 weeks of treatment (BAY 85 3934 arm) in Study 15141, or * Completed 16 weeks of treatment (BAY 85 3934 or darbepoetin arm) in Study 15261 without a dose suspension lasting > 6 consecutive weeks, or * HbS Phase subject (BAY 85 3934 or darbepoetin arm) in Study 15653 (this study): * Had mean Hb concentration of 10.0 to 12.0 g/dL for at least 2 consecutive visits after HbS Phase Visit 2, and *Did not have a dose suspension lasting > 6 consecutive weeks in the HbS Phase 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 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: - A scheduled kidney transplant or any other organ transplant within the next 6 months (being on a waiting list does not exclude the subject) - BAY 85 3934 is eliminated via uridine-diphosphateglucuronosyltransferase 1 family, polypeptide A1 (UGT1A1), therefore the following UGT1A1 inhibitors have to be excluded: * Anti-retroviral drugs, e.g., ritonavir, saquinavir, atazanavir, indinavir, lopinavir, nefinavir * Tyrosine kinase inhibitors, e.g., erlotinib, pazopanib, nilotinib, sorafenib, regorafenib * Other drugs, e.g., tranilast, paracetamol / acetaminophen (single oral doses allowed; prescribed continuous dosing is not allowed) , probenecid, phenobarbital - Red blood cell (RBC) containing transfusion within the 8 weeks before baseline - Sustained, poorly controlled arterial hypertension or hypotension at baseline, defined as blood pressure = 180/110 mmHg or systolic blood pressure 110 bpm, atrial flutter , prolonged QT > 500 msec, third degree atrioventricular [AV] block if not treated with a pacemaker - New York Heart Association Class III or IV congestive heart failure - Severe hepatic insufficiency (defined as alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 x the upper limit of normal [ULN], total bilirubin > 2 mg/dL, or Child Pugh B or C) or active hepatitis, in the investigator's opinion - An ongoing serious adverse event (SAE) from Study 15141 or Study 15261 that is assessed as related to study drug - Infertile male subjects or male subjects who agree not to act as sperm donors from the time of signing of the IC form until 16 weeks after the last dose of study drug and who agree to use 2 reliable, safe, and highly effective methods of contraception simultaneously during the study and for 16 weeks after receiving the last dose of study drug; this must include a barrier method (condoms plus spermicide gel in combination with contraceptive hormonal implants, combined oral contraceptives, or intrauterine devices) for 16 weeks after the last dose of BAY 85-3934; Women without childbearing potential, defined as (a) postmenopausal women (women with 12 months of spontaneous amenorrhea or with 6 months of spontaneousamenorrhea and serum follicle stimulating hormone concentrations > 30 mIU/mL), (b) women with bilateral tubal ligation, (c) women with bilateral ovarectomy, or (d) women with hysterectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 1) Change in local laboratory haemoglobin level from baseline 2) Number of participants with serious adverse events as a measure of safety and tolerability;Timepoint(s) of evaluation of this end point: 1) Baseline up to 36 months 2) Up to 36 months;Secondary Objective: 1) To evaluate other efficacy variables of treatment with BAY 85-3934 compared with darbepoetin. 2) To evaluate other safety variables of treatment with BAY 85-3934 compared with darbepoetin ;Main Objective: 1) To evaluate efficacy of treatment with BAY 85-3934 compared with darbepoetin alfa as measured by change from baseline to post-baseline time points in haemoglobin (Hb) levels. 2) To evaluate safety and tolerability of treatment with BAY 85-3934 compared with darbepoetin by events of special interest, adjudicated serious adverse events (SAEs), and SAEs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1-3) Up to 36 months 4-11) Baseline up to 36 months;Secondary end point(s): 1) Maintenance in haemoglobin target range (10.0 to 12.0 g/dL) 2) Treatment exposure 3) Number of subjects requiring titration of dose 4) Change of reticulocyte count from baseline of this study 5) Change of reticulocyte count from baseline of study 15141 or 15261 6) Change of red blood cell count from baseline of this study 7) Change of red blood cell count from baseline of study 15141 or 15261 8) Change of hematocrit from baseline of this study 9) Change of hematocrit from baseline of study 15141 or 15261 10) Change of central laboratory haemoglobin level from baseline of this study 11) Change of central laboratory haemoglobin level from baseline of study 15141 or 15261 | — |
Countries
Australia, Bulgaria, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Poland, Romania, Spain, Turkey, United Kingdom
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed