Trial Condition(s):

Anemia, Renal Insufficiency, Chronic

Maintenance treatment of renal anemia in dialysis subjects (MIYABI HD-M)

Bayer Identifier:

19352

ClinicalTrials.gov Identifier:

NCT03543657

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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).

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

Trial Summary

Enrollment Goal

229

Trial Dates

June2018

December2019

Phase

Could I receive a placebo?

Yes

Products

Musredo (Molidustat, BAY85-3934)

Accepts Healthy Volunteers

Where to Participate

Locations

Status

Locations	Status
Locations Asahikawa-Kosei General Hospital Asahikawa, Japan, 078-8211	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Itami Kidney Clinic Noboribetsu, Japan, 059-0026	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Ishikari Hospital Ishikari, Japan, 061-3213	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Souen Central Hospital Sapporo, Japan, 060-0008	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Seisuikai Yoshioka Mahoroba Clinic Kurokawa-gun, Japan, 981-3632	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Eijinkai Hospital Osaki, Japan, 989-6117	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Yamagata Tokushukai Hospital Yamagata, Japan, 990-0834	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Tsuchiura Beryl Clinic Tsuchiura, Japan, 300-0062	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Tokiwa Clinic Totte, Japan, 302-0011	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Kikuchi Medical Clinic Tsukuba, Japan, 305-0861	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Mito Kyodo General Hospital Mito, Japan, 310-0015	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Japanese Red Cross Koga Hospital Koga, Japan, 306-0014	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Ibaraki Prefectural Central Hospital Kasama, Japan, 309-1793	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Todachuo General Hospital Toda, Japan, 335-0023	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Saiyu Clinic Koshigaya, Japan, 343-0823	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Higashimatsuyamakohjin Clinic Higashimatsuyama, Japan, 355-0016	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Kisarazu Clinic Kisarazu, Japan, 292-0805	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Medical corporation association Shunshin-kai Inage hospital Chiba, Japan, 263-0043	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Shinkashiwa Clinic Kashiwa, Japan, 277-0084	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Kodaira Kitaguchi Clinic Kodaira, Japan, 187-0001	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Chigasaki Central Clinic Chigasaki, Japan, 253-0052	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Yokohama Jin Clinic Yokohama, Japan, 224-0032	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Eda Clinic Yokohama, Japan, 225-0015	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Kaminagaya Saitou Clinic Yokohama, Japan, 233-0013	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Honatsugi Medical Clinic Atsugi, Japan, 243-0013	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Sabae kidney Clinic Sabae, Japan, 916-0044	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Maruko Central Hospital Ueda, Japan, 386-0405	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Iida Hospital Iida, Japan, 395-8505	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Matsumoto City Hospital Matsumoto, Japan, 390-1401	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Kanno Dialysis & Vascular Access Clinic Matsumoto, Japan, 390-0821	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Medical Corporation Suzukihinyoukika Nagano, Japan, 380-0904	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Hakuyoukai Medical corporation Hakuyoukai Hospital Nagoya, Japan, 465-0025	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Toyonaka Keijinkai Clinic Toyonaka, Japan, 560-0004	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Chibune Clinic Osaka, Japan, 555-0001	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Akagaki Clinic Osaka, Japan, 543-0052	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Nishi Shinryosho Osaka, Japan, 552-0007	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Arisawa General Hospital Hirakata, Japan, 573-1195	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Saint Hill Hospital Ube, Japan, 755-0155	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Kaisei Hospital Sakaide, Japan, 762-0007	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Kuwajima Clinic Niihama, Japan, 792-0812	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Houshikai Kano hospital Kasuya-gun, Japan, 811-0120	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Saiseikai Yahata General Hospital Kitakyushu, Japan, 805-0050	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Ikeda Vascular Access Nephrology Dialysis Fukuoka, Japan, 810-0012	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Oohashi internal medicine circulatory Clinic Fukuoka, Japan, 815-0038	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Nagasaki Kidney Hospital Nagasaki, Japan, 850-0032	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Ueki Imafuji Clinic Kumamoto, Japan, 861-0135	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Public Central Hospital of Matto Ishikawa Hakusan, Japan, 924-8588	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Koizumi Cardiology Medical Clinic Chitose, Japan, 066-0062	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Sanshikai Toho Hospital Midori, Japan, 379-2311	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Hanyu General Hospital Hanyu, Japan, 348-0045	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Iwatsuki-minami Hospital Saitama, Japan, 339-0033	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Hachioji Azumacho Clinic Hachioji, Japan, 192-0082	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937
Locations Toshiba Rinkan Hospital Sagamihara, Japan, 252-0385	Status Completed	Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937

Trial Design

A randomized, active-controlled, double-blinded, double-dummy, parallel-group, multicenter study to investigate the efficacy and safety of oral molidustat in comparison to darbepoetin alfa in dialysis subjects treated with Erythropoiesis-Stimulating Agents (ESAs)

Trial Type:

Interventional

Intervention Type:

Drug

Trial Purpose:

Treatment

Allocation:

Randomized

Blinding:

N/A

Assignment:

Parallel Assignment

Trial Arms:

Primary Outcome

The mean Hb level during the evaluation period
Timeframe: From week 33 to 36

The change in mean Hb level during the evaluation period from baseline
Timeframe: Baseline and week 33 to 36

Secondary Outcome

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
Timeframe: From week 33 to 36

Proportion of subjects who meet each component of the response
Response: (i) Mean of the Hb levels in the target range (ii) ≥ 50% of the Hb levels in the target range (iii) No rescue treatment
Timeframe: From week 33 to 36

Hb level
Timeframe: Up to 52 weeks

Change in Hb level
Timeframe: Baseline and up to 52 weeks

Proportion of subjects whose mean hemoglobin level is in the target range
Timeframe: From week 33 to 36

Proportion of subjects whose mean hemoglobin level is above the target range
Timeframe: From week 33 to 36

Proportion of subjects whose mean hemoglobin level is below the target range
Timeframe: From week 33 to 36

Proportion of subjects with hemoglobin levels in the target range
Timeframe: Up to 52 weeks

Proportion of subjects with hemoglobin levels above the target range
Timeframe: Up to 52 weeks

Proportion of subjects with hemoglobin levels below the target range
Timeframe: Up to 52 weeks

Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week
Defined as change in Hb level / duration between two visits (weeks)
Timeframe: Up to 52 weeks

Number of participants with serious adverse events
Timeframe: Up to 52 weeks

Maximum concentration (Cmax)
Timeframe: At baseline, week 8, week 24 and week 52

Area under the concentration-time curve (AUC)
Timeframe: At baseline, week 8, week 24 and week 52

EPO (Erythropoietin) serum concentration
Timeframe: At baseline, week 8, week 24 and week 52

Anemia, Renal Insufficiency, Chronic

Bayer Identifier:

ClinicalTrials.gov Identifier:

EudraCT Number:

Trial Purpose

Key Participation Requirements

sex

age

20 Years

No Limit

Inclusion Criteria

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Trial Summary

Enrollment Goal

Trial Dates

Phase

Could I receive a placebo?

Products

Accepts Healthy Volunteers

Where to Participate

Trial Design

Primary Outcome

Secondary Outcome

Additional Information