check_circleStudy Completed

Anemia, Renal Insufficiency, Chronic

Bayer Identifier:

19352

ClinicalTrials.gov Identifier:

NCT03543657

EudraCT Number:

Not Available

EU CT Number:

Not Available
Maintenance treatment of renal anemia in dialysis subjects

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).

Key Participants Requirements

Sex

All

Age

20 - N/A
  • - 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
  • - 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
June 2018 - December 2019
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Musredo (Molidustat, BAY85-3934)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Asahikawa-Kosei General HospitalAsahikawa, 078-8211, Japan
Completed
Itami Kidney ClinicNoboribetsu, 059-0026, Japan
Completed
Ishikari HospitalIshikari, 061-3213, Japan
Completed
Souen Central HospitalSapporo, 060-0008, Japan
Completed
Seisuikai Yoshioka Mahoroba ClinicKurokawa-gun, 981-3632, Japan
Completed
Eijinkai HospitalOsaki, 989-6117, Japan
Completed
Yamagata Tokushukai HospitalYamagata, 990-0834, Japan
Completed
Tsuchiura Beryl ClinicTsuchiura, 300-0062, Japan
Completed
Tokiwa ClinicTotte, 302-0011, Japan
Completed
Kikuchi Medical ClinicTsukuba, 305-0861, Japan
Completed
Mito Kyodo General HospitalMito, 310-0015, Japan
Completed
Japanese Red Cross Koga HospitalKoga, 306-0014, Japan
Completed
Ibaraki Prefectural Central HospitalKasama, 309-1793, Japan
Completed
Todachuo General HospitalToda, 335-0023, Japan
Completed
Saiyu ClinicKoshigaya, 343-0823, Japan
Completed
Higashimatsuyamakohjin ClinicHigashimatsuyama, 355-0016, Japan
Completed
Kisarazu ClinicKisarazu, 292-0805, Japan
Completed
Medical corporation association Shunshin-kai Inage hospitalChiba, 263-0043, Japan
Completed
Shinkashiwa ClinicKashiwa, 277-0084, Japan
Completed
Kodaira Kitaguchi ClinicKodaira, 187-0001, Japan
Completed
Chigasaki Central ClinicChigasaki, 253-0052, Japan
Completed
Yokohama Jin ClinicYokohama, 224-0032, Japan
Completed
Eda ClinicYokohama, 225-0015, Japan
Completed
Kaminagaya Saitou ClinicYokohama, 233-0013, Japan
Completed
Honatsugi Medical ClinicAtsugi, 243-0013, Japan
Completed
Sabae kidney ClinicSabae, 916-0044, Japan
Completed
Maruko Central HospitalUeda, 386-0405, Japan
Completed
Iida HospitalIida, 395-8505, Japan
Completed
Matsumoto City HospitalMatsumoto, 390-1401, Japan
Completed
Kanno Dialysis & Vascular Access ClinicMatsumoto, 390-0821, Japan
Withdrawn
Kidney and Dialysis Clinic SUZAKASuzaka, 382-0099, Japan
Completed
Medical Corporation SuzukihinyoukikaNagano, 380-0904, Japan
Completed
Hakuyoukai Medical corporation Hakuyoukai HospitalNagoya, 465-0025, Japan
Completed
Toyonaka Keijinkai ClinicToyonaka, 560-0004, Japan
Completed
Chibune ClinicOsaka, 555-0001, Japan
Completed
Akagaki ClinicOsaka, 543-0052, Japan
Completed
Nishi ShinryoshoOsaka, 552-0007, Japan
Completed
Arisawa General HospitalHirakata, 573-1195, Japan
Completed
Saint Hill HospitalUbe, 755-0155, Japan
Completed
Kaisei HospitalSakaide, 762-0007, Japan
Completed
Kuwajima ClinicNiihama, 792-0812, Japan
Completed
Houshikai Kano hospitalKasuya-gun, 811-0120, Japan
Completed
Saiseikai Yahata General HospitalKitakyushu, 805-0050, Japan
Completed
Ikeda Vascular Access Nephrology DialysisFukuoka, 810-0012, Japan
Completed
Oohashi internal medicine circulatory ClinicFukuoka, 815-0038, Japan
Completed
Nagasaki Kidney HospitalNagasaki, 850-0032, Japan
Completed
Ueki Imafuji ClinicKumamoto, 861-0135, Japan
Completed
Public Central Hospital of Matto IshikawaHakusan, 924-8588, Japan
Completed
Koizumi Cardiology Medical ClinicChitose, 066-0062, Japan
Completed
Sanshikai Toho HospitalMidori, 379-2311, Japan
Completed
Hanyu General HospitalHanyu, 348-0045, Japan
Completed
Iwatsuki-minami HospitalSaitama, 339-0033, Japan
Completed
Hachioji Azumacho ClinicHachioji, 192-0082, Japan
Completed
Toshiba Rinkan HospitalSagamihara, 252-0385, Japan

Primary Outcome

  • The mean Hb level during the evaluation period
    date_rangeTime Frame:
    From week 33 to 36
  • The change in mean Hb level during the evaluation period from baseline
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    From week 33 to 36
  • Hb level
    date_rangeTime Frame:
    Up to 52 weeks
  • Change in 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 33 to 36
  • Proportion of subjects whose mean hemoglobin level is above the target range
    date_rangeTime Frame:
    From week 33 to 36
  • Proportion of subjects whose mean hemoglobin level is below the target range
    date_rangeTime Frame:
    From week 33 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 8, week 24 and week 52
  • Area under the concentration-time curve (AUC)
    date_rangeTime Frame:
    At baseline, week 8, week 24 and week 52
  • EPO (Erythropoietin) serum concentration
    date_rangeTime Frame:
    At baseline, week 8, week 24 and week 52

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
2

Additional Information

Click here to find results for studies related to Bayer products