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

NCT03351166 | Completed Phase 3 DMC

• 1 other identifier: 19351
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 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

Outcome Measures

Primary Outcomes (2)

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

  Up to 8 weeks

• 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 21 to 24

Secondary Outcomes (16)

• 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 21 to 24

• Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once at each visit

  Up to 24 weeks

• Hb level

  Baseline and up to 24 weeks

• Change in Hb level

  Baseline and up to 24 weeks

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 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

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 (20)

Houshikai Kano hospital

Kasuya-gun, Fukuoka, 811-0120, Japan

Location

Matsunami General Hospital

Hashima-gun, Gifu, 501-6062, Japan

Location

Asahikawa-Kosei General Hospital

Asahikawa, Hokkaido, 078-8211, Japan

Location

Ishikari Hospital

Ishikari, Hokkaido, 061-3213, Japan

Location

Itami Kidney Clinic

Noboribetsu, Hokkaido, 059-0026, Japan

Location

Souen Central Hospital

Sapporo, Hokkaido, 060-0008, Japan

Location

Takasago Seibu Hospital

Takasago, Hyōgo, 676-0812, Japan

Location

Japanese Red Cross Koga Hospital

Koga, Ibaraki, 306-0014, Japan

Location

Mito Kyodo General Hospital

Mito, Ibaraki, 310-0015, Japan

Location

Tokiwa Clinic

Totte, Ibaraki, 302-0011, Japan

Location

Tsuchiura Beryl Clinic

Tsuchiura, Ibaraki, 300-0062, Japan

Location

Kikuchi Medical Clinic

Tsukuba, Ibaraki, 305-0861, Japan

Location

Japanese Red Cross Ishinomaki Hospital

Ishinomaki, Miyagi, 986-8522, Japan

Location

Iida Hospital

Iida, Nagano, 395-8505, Japan

Location

Toyonaka Keijinkai Clinic

Toyonaka, Osaka, 560-0004, Japan

Location

Kodaira Kitaguchi Clinic

Kodaira, Tokyo, 187-0001, Japan

Location

Medical corporation association Shunshin-kai Inage hospital

Chiba, 263-0043, Japan

Location

Fukuoka Renal Clinic

Fukuoka, 810-0004, Japan

Location

Ohmiya Chuo General Hospital

Saitama, 331-8711, Japan

Location

Yamagata Tokushukai Hospital

Yamagata, 990-0834, Japan

Location

Related Publications (2)

• 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.

  PMID: 33506635 DERIVED

• 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: November 20, 2017
• First Posted: November 22, 2017
• Study Start: January 22, 2018
• Primary Completion: October 23, 2018
• Study Completion: November 20, 2018
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

JP (20)