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MIYABI HD-M: Maintenance Treatment of Renal Anemia in Dialysis Subjects

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT03543657
Collaborator
(none)
229
Enrollment
53
Locations
2
Arms
18
Actual Duration (Months)
4.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Molidustat (BAY85-3934)
  • Drug: Darbepoetin alfa
  • Drug: Placebo of Molidustat (BAY85-3934)
  • Drug: Placebo of Darbepoetin alfa
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
229 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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)
Actual Study Start Date :
Jun 23, 2018
Actual Primary Completion Date :
Aug 7, 2019
Actual Study Completion Date :
Dec 24, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Molidustat group

Subjects in the molidustat group will receive molidustat and darbepoetin alfa placebo.

Drug: Molidustat (BAY85-3934)
Starting dose of molidustat will be titrated based on the subject's Hb (Hemoglobin) response. Administrated orally once daily (OD).

Drug: Placebo of Darbepoetin alfa
Matching placebo of Darbepoetin alfa.
Active Comparator: Darbepoetin alfa group

Subjects in the darbepoetin alfa group will receive molidustat placebo and darbepoetin alfa.

Drug: Darbepoetin alfa
Starting dose of darbepoetin alfa will be titrated based on the subject's Hb (Hemoglobin) response. Administrated weekly or once every two weeks by intravenous injection.

Drug: Placebo of Molidustat (BAY85-3934)
Matching placebo of Molidustat.

Outcome Measures

Primary Outcome Measures

  1. The mean Hb level during the evaluation period [From week 33 to 36]

  2. The change in mean Hb level during the evaluation period from baseline [Baseline and week 33 to 36]

Secondary Outcome Measures

  1. Responder rate: proportion of responders among the subjects [From week 33 to 36]

    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

  2. Proportion of subjects who meet each component of the response [From week 33 to 36]

    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

  3. Hb level [Up to 52 weeks]

  4. Change in Hb level [Baseline and up to 52 weeks]

  5. Proportion of subjects whose mean hemoglobin level is in the target range [From week 33 to 36]

  6. Proportion of subjects whose mean hemoglobin level is above the target range [From week 33 to 36]

  7. Proportion of subjects whose mean hemoglobin level is below the target range [From week 33 to 36]

  8. Proportion of subjects with hemoglobin levels in the target range [Up to 52 weeks]

  9. Proportion of subjects with hemoglobin levels above the target range [Up to 52 weeks]

  10. Proportion of subjects with hemoglobin levels below the target range [Up to 52 weeks]

  11. Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week [Up to 52 weeks]

    Defined as change in Hb level / duration between two visits (weeks)

  12. Number of participants with serious adverse events [Up to 52 weeks]

  13. Maximum concentration (Cmax) [At baseline, week 8, week 24 and week 52]

  14. Area under the concentration-time curve (AUC) [At baseline, week 8, week 24 and week 52]

  15. EPO (Erythropoietin) serum concentration [At baseline, week 8, week 24 and week 52]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hakuyoukai Medical corporation Hakuyoukai Hospital Nagoya Aichi Japan 465-0025
2 Shinkashiwa Clinic Kashiwa Chiba Japan 277-0084
3 Kisarazu Clinic Kisarazu Chiba Japan 292-0805
4 Kuwajima Clinic Niihama Ehime Japan 792-0812
5 Sabae kidney Clinic Sabae Fukui Japan 916-0044
6 Houshikai Kano hospital Kasuya-gun Fukuoka Japan 811-0120
7 Saiseikai Yahata General Hospital Kitakyushu Fukuoka Japan 805-0050
8 Sanshikai Toho Hospital Midori Gunma Japan 379-2311
9 Asahikawa-Kosei General Hospital Asahikawa Hokkaido Japan 078-8211
10 Koizumi Cardiology Medical Clinic Chitose Hokkaido Japan 066-0062
11 Ishikari Hospital Ishikari Hokkaido Japan 061-3213
12 Itami Kidney Clinic Noboribetsu Hokkaido Japan 059-0026
13 Souen Central Hospital Sapporo Hokkaido Japan 060-0008
14 Ibaraki Prefectural Central Hospital Kasama Ibaraki Japan 309-1793
15 Japanese Red Cross Koga Hospital Koga Ibaraki Japan 306-0014
16 Mito Kyodo General Hospital Mito Ibaraki Japan 310-0015
17 Tokiwa Clinic Totte Ibaraki Japan 302-0011
18 Tsuchiura Beryl Clinic Tsuchiura Ibaraki Japan 300-0062
19 Kikuchi Medical Clinic Tsukuba Ibaraki Japan 305-0861
20 Public Central Hospital of Matto Ishikawa Hakusan Ishikawa Japan 924-8588
21 Kaisei Hospital Sakaide Kagawa Japan 762-0007
22 Honatsugi Medical Clinic Atsugi Kanagawa Japan 243-0013
23 Chigasaki Central Clinic Chigasaki Kanagawa Japan 253-0052
24 Toshiba Rinkan Hospital Sagamihara Kanagawa Japan 252-0385
25 Yokohama Jin Clinic Yokohama Kanagawa Japan 224-0032
26 Eda Clinic Yokohama Kanagawa Japan 225-0015
27 Kaminagaya Saitou Clinic Yokohama Kanagawa Japan 233-0013
28 Seisuikai Yoshioka Mahoroba Clinic Kurokawa-gun Miyagi Japan 981-3632
29 Eijinkai Hospital Osaki Miyagi Japan 989-6117
30 Iida Hospital Iida Nagano Japan 395-8505
31 Kanno Dialysis & Vascular Access Clinic Matsumoto Nagano Japan 390-0821
32 Matsumoto City Hospital Matsumoto Nagano Japan 390-1401
33 Maruko Central Hospital Ueda Nagano Japan 386-0405
34 Arisawa General Hospital Hirakata Osaka Japan 573-1195
35 Toyonaka Keijinkai Clinic Toyonaka Osaka Japan 560-0004
36 Hanyu General Hospital Hanyu Saitama Japan 348-0045
37 Higashimatsuyamakohjin Clinic Higashimatsuyama Saitama Japan 355-0016
38 Saiyu Clinic Koshigaya Saitama Japan 343-0823
39 Todachuo General Hospital Toda Saitama Japan 335-0023
40 Hachioji Azumacho Clinic Hachioji Tokyo Japan 192-0082
41 Kodaira Kitaguchi Clinic Kodaira Tokyo Japan 187-0001
42 Saint Hill Hospital Ube Yamaguchi Japan 755-0155
43 Medical corporation association Shunshin-kai Inage hospital Chiba Japan 263-0043
44 Ikeda Vascular Access Nephrology Dialysis Fukuoka Japan 810-0012
45 Oohashi internal medicine circulatory Clinic Fukuoka Japan 815-0038
46 Ueki Imafuji Clinic Kumamoto Japan 861-0135
47 Medical Corporation Suzukihinyoukika Nagano Japan 380-0904
48 Nagasaki Kidney Hospital Nagasaki Japan 850-0032
49 Akagaki Clinic Osaka Japan 543-0052
50 Nishi Shinryosho Osaka Japan 552-0007
51 Chibune Clinic Osaka Japan 555-0001
52 Iwatsuki-minami Hospital Saitama Japan 339-0033
53 Yamagata Tokushukai Hospital Yamagata Japan 990-0834

Sponsors and Collaborators

  • Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT03543657
Other Study ID Numbers:
  • 19352
First Posted:
Jun 1, 2018
Last Update Posted:
Jan 29, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Anemia
Darbepoetin alfa

Study Results

No Results Posted as of Jan 29, 2021