A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects

NCT ID: NCT03418168

Last Updated: 2021-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-22
• Study Completion Date: 2019-07-29

Brief Summary

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

Conditions

Anemia; Renal Insufficiency, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Molidustat (BAY85-3934)

Molidustat group

Group Type: EXPERIMENTAL

Molidustat (BAY85-3934)

Intervention Type: DRUG

Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response

Interventions

Molidustat (BAY85-3934)

Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kainan Hospital

Yatomi, Aichi-ken, Japan

Ehime Prefectural Central Hospital

Matsuyama, Ehime, Japan

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

JCHO Kyushu Hospital

Kitakyushu, Fukuoka, Japan

Kurume University Hospital

Kurume, Fukuoka, Japan

Elm Grove Clinic

Sapporo, Hokkaido, Japan

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Fujisawa City Hospital

Fujisawa, Kanagawa, Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Toranomon Hospital Kajigaya

Kawasaki, Kanagawa, Japan

Showa University Fujigaoka Hospital

Yokohama, Kanagawa, Japan

Tohoku Medical and Pharmaceutical University Hospital

Sendai, Miyagi, Japan

Niigata Prefectural Shibata Hospital

Shibata, Niigata, Japan

National Hospital Organization Beppu Medical Center

Beppu, Oita Prefecture, Japan

Okinawa prefectural Chubu Hospital

Uruma, Okinawa, Japan

Fuchu Hospital

Izumi, Osaka, Japan

Fukui-ken Saiseikai Hospital

Fukui, , Japan

Kyushu University Hospital

Fukuoka, , Japan

Fukuoka University Hospital

Fukuoka, , Japan

Japanese Red Cross Fukuoka Hospital

Fukuoka, , Japan

Fukushima Medical University Hospital

Fukushima, , Japan

Asahi University Hospital

Gifu, , Japan

National Hospital Organization Kyoto Medical Center

Kyoto, , Japan

Nara Prefecture General Medical Center

Nara, , Japan

Niigata City General Hospital

Niigata, , Japan

Osaka General Medical Center

Osaka, , Japan

Japanese Red Cross Oita Hospital

Ōita, , Japan

Countries

Japan

References

Akizawa T, Taguchi M, Matsuda Y, Iekushi K, Yamada T, Yamamoto H. Molidustat for the treatment of renal anaemia in patients with dialysis-dependent chronic kidney disease: design and rationale of three phase III studies. BMJ Open. 2019 Jun 14;9(6):e026602. doi: 10.1136/bmjopen-2018-026602.

Reference Type: DERIVED

PMID: 31203241 (View on PubMed)

Related Links

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Other Identifiers

19353

Identifier Type: -

Identifier Source: org_study_id