Trial Condition(s):

Anemia, Renal Insufficiency, Chronic

A study of Molidustat for treatment of renal anemia in peritoneal dialysis subjects (MIYABI PD)

Bayer Identifier:

19353

ClinicalTrials.gov Identifier:

NCT03418168

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The purpose of this study is to evaluate the efficacy and safety of molidustat in peritoneal dialysis subjects with renal anemia

Inclusion Criteria
- 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 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≥ 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)

Trial Summary

Enrollment Goal
51
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Musredo (Molidustat, BAY85-3934)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Fukushima Medical University Hospital

Fukushima, Japan, 960-1295

Status
Completed
 
Locations

Niigata Prefectural Shibata Hospital

Shibata, Japan, 957-8588

Status
Completed
 
Locations

Showa University Fujigaoka Hospital

Yokohama, Japan, 227-8501

Status
Completed
 
Locations

Fujisawa City Hospital

Fujisawa, Japan, 251-8550

Status
Completed
 
Locations

Shonan Kamakura General Hospital

Kamakura, Japan, 247-8533

Status
Completed
 
Locations

Kainan Hospital

Yatomi, Japan, 498-8502

Status
Completed
 
Locations

Asahi University Hospital

Gifu, Japan, 500-8523

Status
Completed
 
Locations

Osaka General Medical Center

Osaka, Japan, 558-8558

Status
Completed
 
Locations

Nara Prefecture General Medical Center

Nara, Japan, 630-8581

Status
Completed
 
Locations

Ehime Prefectural Central Hospital

Matsuyama, Japan, 790-0024

Status
Completed
 
Locations

Kokura Memorial Hospital

Kitakyushu, Japan, 802-8555

Status
Completed
 
Locations

Kyushu University Hospital

Fukuoka, Japan, 812-8582

Status
Completed
 
Locations

Fukuoka University Hospital

Fukuoka, Japan, 814-0180

Status
Completed
 
Locations

JCHO Kyushu Hospital

Kitakyushu, Japan, 806-8501

Status
Completed
 
Locations

Japanese Red Cross Fukuoka Hospital

Fukuoka, Japan, 815-8555

Status
Completed
 
Locations

Kurume University Hospital

Kurume, Japan, 830-0011

Status
Completed
 
Locations

Japanese Red Cross Oita Hospital

Oita, Japan, 870-0033

Status
Completed
 
Locations

Okinawa prefectural Chubu Hospital

Uruma, Japan, 904-2293

Status
Completed
 
Locations

Elm Grove Clinic

Sapporo, Japan, 003-0814

Status
Completed
 
Locations

Tohoku Medical and Pharmaceutical University Hospital

Sendai, Japan, 983-8512

Status
Completed
 
Locations

Niigata City General Hospital

Niigata, Japan, 950-1197

Status
Completed
 
Locations

Toranomon Hospital Kajigaya

Kawasaki, Japan, 213-8587

Status
Completed
 
Locations

Fukui-ken Saiseikai Hospital

Fukui, Japan, 918-8503

Status
Completed
 
Locations

National Hospital Organization Kyoto Medical Center

Kyoto, Japan, 612-8555

Status
Completed
 
Locations

Fuchu Hospital

Izumi, Japan, 594-0076

Status
Completed
 
Locations

Kobe City Medical Center General Hospital

Kobe, Japan, 650-0047

Status
Completed
 
Locations

National Hospital Organization Beppu Medical Center

Beppu, Japan, 874-0011

Status
Completed
 

Trial Design