check_circleStudy Completed

Anemia, Renal Insufficiency, Chronic

Bayer Identifier:

19349

ClinicalTrials.gov Identifier:

NCT03350321

EudraCT Number:

Not Available

EU CT Number:

Not Available
A study of Molidustat for correction of renal anemia in non-dialysis subjects

Trial purpose

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

Key Participants Requirements

Sex

All

Age

20 - N/A
  • - Subjects with estimated glomerular filtration rate (eGFR)< 60 mL/min/1.73m^2 (Chronic kidney disease [CKD] stages 3 to 5)
    - Body weight > 40 and ≤ 160 kg at screening
    - Male or female subject ≥ 20 years of age at screening
    - Not on dialysis and not expected to start dialysis during the study period
    - Not treated with ESAs and/or HIF-PH inhibitors within 8 weeks prior to randomization
    - Mean of the last 2 central laboratory Hb levels during the screening period must be ≥ 8.0 and < 11.0 g/dL (2 measurements must be taken ≥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) and the last measurements must be taken within 14 days prior to randomization
    - Ferritin ≥ 50 ng/mL at screening
  • - 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)

Trial summary

Enrollment Goal
162
Trial Dates
December 2017 - October 2019
Phase
Phase 3
Could I Receive a placebo
No
Products
Musredo (Molidustat, BAY85-3934)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Teine Keijinkai ClinicSapporo, 006-8555, Japan
Completed
Japanese Red Cross Ishinomaki HospitalIshinomaki, 986-8522, Japan
Completed
Fukushima Medical University HospitalFukushima, 960-1295, Japan
Completed
Mito Kyodo General HospitalMito, 310-0015, Japan
Completed
National hospital Organization Mito Medical CenterHigashiibaraki, 311-3193, Japan
Completed
Kitasato University Medical CenterKitamoto, 364-8501, Japan
Completed
Seikeikai New Tokyo Heart ClinicMatsudo, 271-0077, Japan
Completed
Nihon University Itabashi HospitalItabashi-ku, 173-8610, Japan
Completed
Showa University Koto Toyosu HospitalKoto-ku, 135-8577, Japan
Completed
Fujisawa City HospitalFujisawa, 251-8550, Japan
Completed
Showa University Fujigaoka HospitalYokohama, 227-8501, Japan
Completed
Yokosuka Kyosai HospitalYokosuka, 238-8558, Japan
Completed
Koukan ClinicKawasaki, 210-0852, Japan
Completed
Niigata Prefectural Shibata HospitalShibata, 957-8588, Japan
Completed
Fukui Prefectural HospitalFukui, 910-8526, Japan
Completed
University of Yamanashi HospitalChuo, 409-3898, Japan
Completed
Asama Nanroku Komoro Medical CenterKomoro, 384-8588, Japan
Completed
Asahi University HospitalGifu, 500-8523, Japan
Completed
Suruga ClinicShizuoka, 424-0855, Japan
Completed
Iwata City HospitalIwata, 438-8550, Japan
Completed
Shizuoka Saiseikai General HospitalShizuoka, 422-8527, Japan
Completed
Kainan HospitalYatomi, 498-8502, Japan
Completed
JCHO Yokkaichi Hazu Medical CenterYokkaichi, 510-0016, Japan
Completed
Uji-Tokushukai Medical CenterUji, 611-0041, Japan
Completed
Chibune ClinicOsaka, 555-0001, Japan
Completed
Kitano HospitalOsaka, 530-8480, Japan
Completed
Osaka Pref. Saiseikai Tondabayashi HospitalTondabayashi, 584-0082, Japan
Completed
Social Corporation Keigakukai Minamiosaka HospitalOsaka, 559-0012, Japan
Completed
Nippon Life HospitalOsaka, 550-0006, Japan
Completed
Osaka General Medical CenterOsaka, 558-8558, Japan
Completed
National Hospital Organization Kobe Medical CenterKobe, 654-0155, Japan
Completed
Nippon Kokan Fukuyama HospitalFukuyama, 721-0927, Japan
Completed
Mazda Hospital of Mazda Motor CorporationAki-gun, 735-8585, Japan
Withdrawn
Higashihiroshima Medical CenterHigashihiroshima, 739-0041, Japan
Completed
KenAiKai medical corporation Akiyama clinicTakamatsu, 761-1701, Japan
Completed
Ehime Prefectural Central HospitalMatsuyama, 790-0024, Japan
Completed
Saiseikai Matsuyama HospitalMatsuyama, 791-8026, Japan
Completed
Iizuka HospitalIizuka, 820-8505, Japan
Completed
Fukuoka University HospitalFukuoka, 814-0180, Japan
Completed
Kokura Memorial HospitalKitakyushu, 802-8555, Japan
Completed
Steel Memorial Yawata HospitalKitakyushu, 805-8508, Japan
Completed
Kyushu University HospitalFukuoka, 812-8582, Japan
Completed
Kurume University HospitalKurume, 830-0011, Japan
Completed
St.Mary's HospitalKurume, 830-8543, Japan
Completed
National Fukuoka-Higashi Medical CenterKoga, 811-3195, Japan
Completed
Japanese Red Cross Oita HospitalOita, 870-0033, Japan
Completed
Ikeda HospitalKanoya, 893-0024, Japan
Completed
Okinawa prefectural Chubu HospitalUruma, 904-2293, Japan
Completed
Toshima HospitalItabashi-ku, 173-0015, Japan
Completed
National Hospital Organization Tokyo Medical CenterMeguro-ku, 152-8902, Japan
Completed
National Hospital Organization Kochi National HospitalKochi, 780-8077, Japan
Completed
Matsunami Health Promotion ClinicHashima-gun, 501-6061, Japan
Completed
National Hospital Organization Osaka National HospitalOsaka, 540-0006, Japan
Completed
Osaka Saiseikai Senri HospitalSuita, 565-0862, Japan
Completed
National Hospital Organization Kyushu Medical CenterFukuoka, 810-8563, Japan
Completed
Kumamoto Rosai HospitalYatsushiro, 866-8533, Japan
Completed
Arao Municipal HospitalArao, 864-0041, Japan
Completed
Wakayama Medical University HospitalWakayama, 641-8510, Japan
Completed
Osaka Red Cross HospitalOsaka, 543-8555, Japan
Completed
Kobe City Medical Center General HospitalKobe, 650-0047, Japan
Completed
Nara Prefecture General Medical CenterNara, 630-8581, Japan
Completed
Gifu Prefectural Tajimi HospitalTajimi, 507-8522, Japan
Withdrawn
Mito Saiseikai General HospitalMito, 311-4198, Japan

Primary Outcome

  • Mean Hb (Hemoglobin) level
    date_rangeTime Frame:
    From week 30 to 36
  • Change in hemoglobin level from baseline to the average during the evaluation period
    date_rangeTime Frame:
    Baseline and week 30 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
    date_rangeTime Frame:
    From week 30 to 36
  • Rate of rise in Hb (Hemoglobin) level (g/dL/week)
    date_rangeTime Frame:
    Up to 8 weeks
  • Rate of rise in Hb (Hemoglobin) level (g/dL/week)
    date_rangeTime Frame:
    Up to 4 weeks
  • 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
    date_rangeTime Frame:
    From week 30 to 36
  • Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once
    date_rangeTime Frame:
    Up to 52 weeks
  • Change in Hb level
    date_rangeTime Frame:
    Baseline and up to 52 weeks
  • Hb level
    date_rangeTime Frame:
    Baseline and up to 52 weeks
  • Proportion of subjects whose mean hemoglobin level is in the target range
    date_rangeTime Frame:
    From week 30 to 36
  • Proportion of subjects whose mean hemoglobin level is above the target range
    date_rangeTime Frame:
    From week 30 to 36
  • Proportion of subjects whose mean hemoglobin level is below the target range
    date_rangeTime Frame:
    From week 30 to 36
  • Proportion of subjects with hemoglobin levels in the target range
    date_rangeTime Frame:
    Up to 52 weeks
  • Proportion of subjects with hemoglobin levels above the target range
    date_rangeTime Frame:
    Up to 52 weeks
  • Proportion of subjects with hemoglobin levels below the target range
    date_rangeTime Frame:
    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)
    date_rangeTime Frame:
    Up to 52 weeks
  • Number of participants with serious adverse events
    date_rangeTime Frame:
    Up to 52 weeks
  • Maximum concentration (Cmax)
    date_rangeTime Frame:
    At baseline, week 12, week 24 and week 52
  • Area under the concentration-time curve (AUC)
    date_rangeTime Frame:
    At baseline, week 12, week 24 and week 52
  • EPO (Erythropoietin) serum concentration
    date_rangeTime Frame:
    At baseline, week 12, week 24 and week 52

Trial design

A randomized, open-label, active-controlled, parallel-group, multicenter study to investigate the efficacy and safety of oral molidustat in comparison to darbepoetin alfa in non-dialysis subjects with renal anemia who are not 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
2

Additional Information

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