Overview
A Study of Molidustat for Maintenance Treatment of Renal Anemia in Non-dialysis Subjects
Status:
Completed
Completed
Trial end date:
2019-11-28
2019-11-28
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to evaluate the efficacy and safety of molidustat in non-dialysis subjects previously treated with Erythropoiesis-Stimulating Agents (ESAs)Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
BayerTreatments:
Darbepoetin alfa
Hematinics
Criteria
Inclusion Criteria:- Subjects with estimated glomerular filtration rate (eGFR)< 60 mL/min/1.73m^2 (Chronic
kidney disease [CKD] stages 3 to 5)
- Have used the same ESA for 8 weeks prior to screening
- Treated with darbepoetin alfa with bi-weekly or monthly dose, epoetin beta pegol with
monthly, OR epoetin alfa/beta weekly or bi-weekly, and having had no more than one
dose change within 8 weeks prior to randomization
- Body weight > 40 and ≤ 160 kg at screening
- Male or female subject ≥ 20 years of age at screening
- Not on dialysis and not expected to start dialysis during the study period
- Mean screening Hb level ≥ 10.0 and < 13.0 g/dL (mean of all central laboratory Hb
levels [at least 2 measurements must be taken ≥ 2 days apart] during the 8-week
screening period, AND all Hb level must be measured by the central laboratory, AND the
difference between the lowest level and highest level is < 1.2 g/dL), with the last
screening Hb level measurement within 14 days prior to randomization
- Ferritin ≥ 100 ng/mL or Transferrin saturation ≥ 20%
Exclusion Criteria:
- New York Heart Association (NYHA) Class III or IV congestive heart failure
- History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial
infarction, stroke, pulmonary thromboembolism, and acute limb ischemia) within 6
months prior to randomization
- Sustained and poorly controlled arterial hypertension (defined as systolic BP (blood
pressure)≥ 180mmHg or diastolic BP ≥ 110mmHg) or hypotension (defined as systolic BP <
90mmHg) at randomization
- Proliferative choroidal or retinal disease, such as neovascular age-related macular
degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g.,
intraocular injections or laser photocoagulation)