Status:
COMPLETED
A Study of Molidustat for Treatment of Renal Anemia in Peritoneal 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 peritoneal dialysis subjects with renal anemia
Eligibility Criteria
Inclusion
- Subject with end-stage kidney disease (ESKD) on peritoneal dialysis prior to assignment and not expected to start maintenance dialysis (e.g., hemodialysis, hemodiafiltration) other than peritoneal dialysis during the study period
- Body weight \> 40 and ≤ 160 kg at screening
- Male or female subject ≥ 20 years of age at screening
- At least one kidney
- Subjects who meet one of the 1 or 2 following criteria
- Subjects untreated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) 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) with the last screening Hb measurement within 14 days prior to study drug assignment
- Subjects pre treated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be ≥ 10.0 and \< 13.0 g/dL (2 measurements must be taken ≥ 2 days apart and the difference between the 2 measurements must be \< 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment
- Subjects who meet one of the 1 or 2 following criteria
- Subjects untreated with ESA at assignment: Subject with ESKD on peritoneal dialysis for at least 2 weeks prior to assignment. AND. Subject not received ESA for 8 weeks prior to assignment. OR. In case of the patient washed out from ESAs, when mean of the last 2 Hb level (at least 2 central laboratory measurements must be taken ≥ 2 days apart) has decrease to ≥ 0.5g/dL from the Hb level (central laboratory measurement) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment should be over 2 week for epoetin-alpha/beta, 4 weeks for darbepoetin alpha or epoetin beta pegol
- Subjects pre treated with ESA at assignment:
- Subject with ESKD on peritoneal dialysis for at least 12 weeks prior to assignment
- Subject treated with ESA by IV or SC within 8 weeks prior to assignment
- Treated with 2 or 4 weekly dose of darbepoetin alfa, 4 weekly dose of epoetin beta pegol, OR 3 times per week, twice per week, weekly or bi-weekly dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to assignment
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 :
February 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2019
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03418168
Start Date
February 22 2018
End Date
July 29 2019
Last Update
January 29 2021
Active Locations (27)
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1
Kainan Hospital
Yatomi, Aichi-ken, Japan, 498-8502
2
Ehime Prefectural Central Hospital
Matsuyama, Ehime, Japan, 790-0024
3
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan, 802-8555
4
JCHO Kyushu Hospital
Kitakyushu, Fukuoka, Japan, 806-8501