A Study of Molidustat for Correction of Renal Anemia in Dialysis Subjects

NCT ID: NCT03351166

Last Updated: 2021-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-22
• Study Completion Date: 2018-11-20

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Molidustat in dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs)

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 dialysis (including, hemodiafiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly
• Body weight > 40 and ≤ 160 kg at screening
• Male or female subject ≥ 20 years of age at screening
• At least one kidney
• Not treated with ESAs and/or HIF-PH inhibitors within 8 weeks prior to randomization. However, in case of the patient washed out from ESAs, when the mean Hb (at least 2 central laboratory measurements must be taken ≥ 2 days apart before dialysis) has decrease to ≥ 0.5 dL from the Hb level (central laboratory measurement, before dialysis) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment was over 1 week for epoetin-alpha, 2 weeks for darbepoetin alpha or 4 weeks for epoetin beta pegol
• Mean of the last 2 Hb level (central laboratory measurement, before dialysis) during the screening period must be ≥ 8.0 and < 10.0 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
• Ferritin ≥ 50 ng/mL at screening

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

Houshikai Kano hospital

Kasuya-gun, Fukuoka, Japan

Matsunami General Hospital

Hashima-gun, Gifu, Japan

Asahikawa-Kosei General Hospital

Asahikawa, Hokkaido, Japan

Ishikari Hospital

Ishikari, Hokkaido, Japan

Itami Kidney Clinic

Noboribetsu, Hokkaido, Japan

Souen Central Hospital

Sapporo, Hokkaido, Japan

Takasago Seibu Hospital

Takasago, Hyōgo, Japan

Japanese Red Cross Koga Hospital

Koga, Ibaraki, Japan

Mito Kyodo General Hospital

Mito, Ibaraki, Japan

Tokiwa Clinic

Totte, Ibaraki, Japan

Tsuchiura Beryl Clinic

Tsuchiura, Ibaraki, Japan

Kikuchi Medical Clinic

Tsukuba, Ibaraki, Japan

Japanese Red Cross Ishinomaki Hospital

Ishinomaki, Miyagi, Japan

Iida Hospital

Iida, Nagano, Japan

Toyonaka Keijinkai Clinic

Toyonaka, Osaka, Japan

Kodaira Kitaguchi Clinic

Kodaira, Tokyo, Japan

Medical corporation association Shunshin-kai Inage hospital

Chiba, , Japan

Fukuoka Renal Clinic

Fukuoka, , Japan

Ohmiya Chuo General Hospital

Saitama, , Japan

Yamagata Tokushukai Hospital

Yamagata, , Japan

Countries

Japan

References

Akizawa T, Nobori K, Matsuda Y, Hayashi Y, Hayasaki T, Yamamoto H. Molidustat for anemia correction in Japanese patients undergoing hemodialysis: a single-arm, phase 3 study. Ther Apher Dial. 2021 Dec;25(6):917-925. doi: 10.1111/1744-9987.13627. Epub 2021 Mar 22.

Reference Type: DERIVED

PMID: 33506635 (View on PubMed)

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

http://clinicaltrials.bayer.com/

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Other Identifiers

19351

Identifier Type: -

Identifier Source: org_study_id