Maintenance Treatment of Renal Anemia in Dialysis Subjects

NCT ID: NCT03543657

Last Updated: 2021-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 229 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-23
• Study Completion Date: 2019-12-24

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of molidustat in comparison to darbepoetin alfa in dialysis subjects with renal anemia who are treated with Erythropoiesis-Stimulating Agents (ESAs).

Conditions

Anemia; Renal Insufficiency, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Molidustat group

Subjects in the molidustat group will receive molidustat and darbepoetin alfa placebo.

Group Type: EXPERIMENTAL

Molidustat (BAY85-3934)

Intervention Type: DRUG

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

Placebo of Darbepoetin alfa

Intervention Type: DRUG

Matching placebo of Darbepoetin alfa.

Darbepoetin alfa group

Subjects in the darbepoetin alfa group will receive molidustat placebo and darbepoetin alfa.

Group Type: ACTIVE_COMPARATOR

Darbepoetin alfa

Intervention Type: DRUG

Starting dose of darbepoetin alfa will be titrated based on the subject's Hb (Hemoglobin) response. Administrated weekly or once every two weeks by intravenous injection.

Placebo of Molidustat (BAY85-3934)

Intervention Type: DRUG

Matching placebo of Molidustat.

Interventions

Molidustat (BAY85-3934)

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

Intervention Type: DRUG

Darbepoetin alfa

Starting dose of darbepoetin alfa will be titrated based on the subject's Hb (Hemoglobin) response. Administrated weekly or once every two weeks by intravenous injection.

Intervention Type: DRUG

Placebo of Molidustat (BAY85-3934)

Matching placebo of Molidustat.

Intervention Type: DRUG

Placebo of Darbepoetin alfa

Matching placebo of Darbepoetin alfa.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject with ESKD (end-stage kidney disease) on regular dialysis (including, hemodiafiltration, hemofiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly for at least 12 weeks prior to randomization
• Body weight (after dialysis) > 40 and ≤ 160 kg at screening
• Male or female subject ≥ 20 years of age at screening
• At least one kidney
• Treated with weekly or bi-weekly dose of darbepoetin alfa, monthly or bi-weekly dose of epoetin beta pegol, OR weekly, biweekly, twice or three times per week dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to randomization
• Mean screening Hb level ≥ 9.5 and < 12.0 g/dL (mean of all central laboratory Hb levels before dialysis [at least 2 measurements must be taken ≥ 2 days apart] during the screening period, AND all Hb level must be measured by the central laboratory, AND the difference between the lowest level and highest level is < 1.2 g/dL), with the last screening Hb level measurement within 14 days prior to randomization
• Ferritin ≥ 100 ng/mL or transferrin saturation ≥ 20% at screening
• Serum folate level and serum vitamin B12 level above lower limit of normal (LLN) 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, poorly controlled arterial hypertension (defined as systolic BP (blood pressure) ≥ 180mmHg or diastolic BP ≥ 110mmHg) or hypotension (defined as systolic BP < 90mmHg) at randomization
• Proliferative choroidal or retinal disease, such as neovascular agerelated macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation) at screening

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

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hakuyoukai Medical corporation Hakuyoukai Hospital

Nagoya, Aichi-ken, Japan

Shinkashiwa Clinic

Kashiwa, Chiba, Japan

Kisarazu Clinic

Kisarazu, Chiba, Japan

Kuwajima Clinic

Niihama, Ehime, Japan

Sabae kidney Clinic

Sabae, Fukui, Japan

Houshikai Kano hospital

Kasuya-gun, Fukuoka, Japan

Saiseikai Yahata General Hospital

Kitakyushu, Fukuoka, Japan

Sanshikai Toho Hospital

Midori, Gunma, Japan

Asahikawa-Kosei General Hospital

Asahikawa, Hokkaido, Japan

Koizumi Cardiology Medical Clinic

Chitose, Hokkaido, Japan

Ishikari Hospital

Ishikari, Hokkaido, Japan

Itami Kidney Clinic

Noboribetsu, Hokkaido, Japan

Souen Central Hospital

Sapporo, Hokkaido, Japan

Ibaraki Prefectural Central Hospital

Kasama, Ibaraki, 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

Public Central Hospital of Matto Ishikawa

Hakusan, Ishikawa-ken, Japan

Kaisei Hospital

Sakaidechō, Kagawa-ken, Japan

Honatsugi Medical Clinic

Atsugi, Kanagawa, Japan

Chigasaki Central Clinic

Chigasaki, Kanagawa, Japan

Toshiba Rinkan Hospital

Sagamihara, Kanagawa, Japan

Yokohama Jin Clinic

Yokohama, Kanagawa, Japan

Eda Clinic

Yokohama, Kanagawa, Japan

Kaminagaya Saitou Clinic

Yokohama, Kanagawa, Japan

Seisuikai Yoshioka Mahoroba Clinic

Kurokawa-gun, Miyagi, Japan

Eijinkai Hospital

Ōsaki, Miyagi, Japan

Iida Hospital

Iida, Nagano, Japan

Kanno Dialysis & Vascular Access Clinic

Matsumoto, Nagano, Japan

Matsumoto City Hospital

Matsumoto, Nagano, Japan

Maruko Central Hospital

Ueda, Nagano, Japan

Arisawa General Hospital

Hirakata, Osaka, Japan

Toyonaka Keijinkai Clinic

Toyonaka, Osaka, Japan

Hanyu General Hospital

Hanyū, Saitama, Japan

Higashimatsuyamakohjin Clinic

Higashi-Matsuyama, Saitama, Japan

Saiyu Clinic

Koshigaya, Saitama, Japan

Todachuo General Hospital

Toda, Saitama, Japan

Hachioji Azumacho Clinic

Hachiōji, Tokyo, Japan

Kodaira Kitaguchi Clinic

Kodaira, Tokyo, Japan

Saint Hill Hospital

Ube, Yamaguchi, Japan

Medical corporation association Shunshin-kai Inage hospital

Chiba, , Japan

Ikeda Vascular Access Nephrology Dialysis

Fukuoka, , Japan

Oohashi internal medicine circulatory Clinic

Fukuoka, , Japan

Ueki Imafuji Clinic

Kumamoto, , Japan

Medical Corporation Suzukihinyoukika

Nagano, , Japan

Nagasaki Kidney Hospital

Nagasaki, , Japan

Akagaki Clinic

Osaka, , Japan

Nishi Shinryosho

Osaka, , Japan

Chibune Clinic

Osaka, , Japan

Iwatsuki-minami Hospital

Saitama, , Japan

Yamagata Tokushukai Hospital

Yamagata, , Japan

Countries

Japan

References

Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

Reference Type: DERIVED

PMID: 36005278 (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)

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Other Identifiers

19352

Identifier Type: -

Identifier Source: org_study_id