Status:
COMPLETED
A Study of Molidustat for Maintenance Treatment 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 previously 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)
- 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
- 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)
Key Trial Info
Start Date :
December 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2019
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT03350347
Start Date
December 13 2017
End Date
November 28 2019
Last Update
January 29 2021
Active Locations (59)
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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