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

A Single Arm, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Dialysis Subjects With Renal Anemia Who Are Not Treated With Erythropoiesis-Stimulating Agents (ESAs)

Sponsors

Lead Sponsor: Bayer

Source Bayer
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)

Overall Status Completed
Start Date January 22, 2018
Completion Date November 20, 2018
Primary Completion Date October 23, 2018
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Rate of rise in Hb (Hemoglobin) level (g/dL/week) Up to 8 weeks
Responder rate: proportion of responders among the subjects Week 21 to 24
Secondary Outcome
Measure Time Frame
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
Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation period Week 21 to 24
Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation period Week 21 to 24
Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period Week 21 to 24
Proportion of subjects with hemoglobin levels above the target range Up to 24 weeks
Proportion of subjects with hemoglobin levels below the target range Up to 24 weeks
Proportion of subjects with hemoglobin levels in the target range Up to 24 weeks
Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week Up to 24 weeks
Number of participants with serious adverse events Up to 24 weeks
Maximum concentration (Cmax) of Molidustat Baseline, Week 8, Week16 and Week 24
Area under the concentration-time curve (AUC) of Molidustat Baseline, Week 8, Week16 and Week 24
EPO (Erythropoietin) serum concentration of Molidustat Baseline, Week 8, Week16 and Week 24
Enrollment 25
Condition
Intervention

Intervention Type: Drug

Intervention Name: Molidustat (BAY85-3934)

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

Arm Group Label: Molidustat (BAY85-3934)

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)

Gender: All

Minimum Age: 20 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
Houshikai Kano hospital | Kasuya-gun, Fukuoka, 811-0120, Japan
Matsunami General Hospital | Hashima-gun, Gifu, 501-6062, Japan
Asahikawa-Kosei General Hospital | Asahikawa, Hokkaido, 078-8211, Japan
Ishikari Hospital | Ishikari, Hokkaido, 061-3213, Japan
Itami Kidney Clinic | Noboribetsu, Hokkaido, 059-0026, Japan
Souen Central Hospital | Sapporo, Hokkaido, 060-0008, Japan
Takasago Seibu Hospital | Takasago, Hyogo, 676-0812, Japan
Japanese Red Cross Koga Hospital | Koga, Ibaraki, 306-0014, Japan
Mito Kyodo General Hospital | Mito, Ibaraki, 310-0015, Japan
Tokiwa Clinic | Totte, Ibaraki, 302-0011, Japan
Tsuchiura Beryl Clinic | Tsuchiura, Ibaraki, 300-0062, Japan
Kikuchi Medical Clinic | Tsukuba, Ibaraki, 305-0861, Japan
Japanese Red Cross Ishinomaki Hospital | Ishinomaki, Miyagi, 986-8522, Japan
Iida Hospital | Iida, Nagano, 395-8505, Japan
Toyonaka Keijinkai Clinic | Toyonaka, Osaka, 560-0004, Japan
Kodaira Kitaguchi Clinic | Kodaira, Tokyo, 187-0001, Japan
Inage Hospital | Chiba, 263-0043, Japan
Fukuoka Renal Clinic | Fukuoka, 810-0004, Japan
Ohmiya Chuo General Hospital | Saitama, 331-8711, Japan
Yamagata Tokushukai Hospital | Yamagata, 990-0834, Japan
Location Countries

Japan

Verification Date

August 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Molidustat (BAY85-3934)

Type: Experimental

Description: Molidustat group

Acronym MIYABI HD-C
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov