Status:
COMPLETED
A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects
Lead Sponsor:
Bayer
Conditions:
Anemia
Renal Insufficiency, Chronic
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of molidustat in non-dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs).
Eligibility Criteria
Inclusion
- Subjects with estimated glomerular filtration rate (eGFR)\< 60 mL/min/1.73m\^2 (Chronic kidney disease \[CKD\] stages 3 to 5)
- 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
- Not treated with ESAs and/or HIF-PH inhibitors within 8 weeks prior to randomization
- Mean of the last 2 central laboratory Hb levels during the screening period must be ≥ 8.0 and \< 11.0 g/dL (2 measurements must be taken ≥ 2 days apart and the difference between the 2 measurements must be \< 1.2 g/dL) and the last measurements must be taken within 14 days prior to randomization
- Ferritin ≥ 50 ng/mL at screening
Exclusion
- 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≥ 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)
Key Trial Info
Start Date :
December 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2019
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT03350321
Start Date
December 12 2017
End Date
October 11 2019
Last Update
January 29 2021
Active Locations (61)
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1
Kainan Hospital
Yatomi, Aichi-ken, Japan, 498-8502
2
Seikeikai New Tokyo Heart Clinic
Matsudo, Chiba, Japan, 271-0077
3
Ehime Prefectural Central Hospital
Matsuyama, Ehime, Japan, 790-0024
4
Saiseikai Matsuyama Hospital
Matsuyama, Ehime, Japan, 791-8026