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

NCT03418168 | Completed Phase 3 DMC

• 1 other identifier: 19353
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 27

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

Outcome Measures

Primary Outcomes (1)

• Responder rate: proportion of responders among the subjects

  Responder is defined as meeting all of the following criteria: (i) Mean of the Hb levels in the target range (ii) ≥ 50% of the Hb levels in the target range (iii) No rescue treatment

  Week 30 to 36

Secondary Outcomes (25)

• Mean Hb (Hemoglobin) level

  Week 30 to 36

• Change in mean Hb level

  Baseline and Week 30 to 36

• Rate of rise in Hb (Hemoglobin) level (g/dL/week)

  Up to 8 weeks

• Rate of rise in Hb (Hemoglobin) level (g/dL/week)

  Up to 4 weeks

• Proportion of subjects who meet each component of the response

  Week 30 to 36

Study Arms (1)

Molidustat (BAY85-3934)

EXPERIMENTAL

Molidustat group

Drug: Molidustat (BAY85-3934)

Interventions

Molidustat (BAY85-3934) DRUG

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

Molidustat (BAY85-3934)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (27)

Kainan Hospital

Yatomi, Aichi-ken, 498-8502, Japan

Location

Ehime Prefectural Central Hospital

Matsuyama, Ehime, 790-0024, Japan

Location

Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8555, Japan

Location

JCHO Kyushu Hospital

Kitakyushu, Fukuoka, 806-8501, Japan

Location

Kurume University Hospital

Kurume, Fukuoka, 830-0011, Japan

Location

Elm Grove Clinic

Sapporo, Hokkaido, 003-0814, Japan

Location

Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0047, Japan

Location

Fujisawa City Hospital

Fujisawa, Kanagawa, 251-8550, Japan

Location

Shonan Kamakura General Hospital

Kamakura, Kanagawa, 247-8533, Japan

Location

Toranomon Hospital Kajigaya

Kawasaki, Kanagawa, 213-8587, Japan

Location

Showa University Fujigaoka Hospital

Yokohama, Kanagawa, 227-8501, Japan

Location

Tohoku Medical and Pharmaceutical University Hospital

Sendai, Miyagi, 983-8512, Japan

Location

Niigata Prefectural Shibata Hospital

Shibata, Niigata, 957-8588, Japan

Location

National Hospital Organization Beppu Medical Center

Beppu, Oita Prefecture, 874-0011, Japan

Location

Okinawa prefectural Chubu Hospital

Uruma, Okinawa, 904-2293, Japan

Location

Fuchu Hospital

Izumi, Osaka, 594-0076, Japan

Location

Fukui-ken Saiseikai Hospital

Fukui, 918-8503, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Fukuoka University Hospital

Fukuoka, 814-0180, Japan

Location

Japanese Red Cross Fukuoka Hospital

Fukuoka, 815-8555, Japan

Location

Fukushima Medical University Hospital

Fukushima, 960-1295, Japan

Location

Asahi University Hospital

Gifu, 500-8523, Japan

Location

National Hospital Organization Kyoto Medical Center

Kyoto, 612-8555, Japan

Location

Nara Prefecture General Medical Center

Nara, 630-8581, Japan

Location

Niigata City General Hospital

Niigata, 950-1197, Japan

Location

Osaka General Medical Center

Osaka, 558-8558, Japan

Location

Japanese Red Cross Oita Hospital

Ōita, 870-0033, Japan

Location

Related Publications (1)

• 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.

  PMID: 31203241 DERIVED

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Interventions

molidustat

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 1, 2018
• Study Start: February 22, 2018
• Primary Completion: July 25, 2019
• Study Completion: July 29, 2019
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

JP (27)