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CompletedNCT02064426DIALOGUE5Updated Sep 20, 2019

Long Term Extension Study for the Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934

A Phase 2 interventional study of Molidustat (BAY85-3934) and Epoetin alfa/beta in Anemia and Renal Insufficiency, Chronic, sponsored by Bayer. Completed at 26 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-20.

Sponsored by Bayer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Evaluate efficacy and safety up to 36 months of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta. Titration will be based on the subject's hemoglobin (Hb) response and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,and 150 mg once daily.

02

Conditions studied

  • Anemia
  • Renal Insufficiency, Chronic

Keywords

  • Anemia of CKD on dialysis
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 88 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Eligible male or female subjects were previously enrolled in Study 16208, have a diagnosis of anemia associated with CKD, and are on hemodialysis.
  • Men who agree to use adequate contraception when sexually active or women without childbearing potential
  • Participation and completion of treatment in Study 16208; subjects must have received 16 weeks of study medication and completed the end of treatment visit (Day 113) in the parent study
  • Mean Hb concentration of 9.5 to 11.5 g/dL, inclusive, during the evaluation period (i.e., the last 4 weeks of the parent study) when the subject completed 16 weeks of treatment with BAY85-3934, epoetin alfa, or epoetin beta in Study 16208

Exclusion criteria

Exclusion Criteria:

  • A scheduled kidney transplant or any other organ transplant within the next 6 months (being on a waiting list does not exclude the subject)
  • Updates to medical and surgical history which meet the exclusion criteria in the parent study
  • Subjects treated with immunosuppressive therapy and the breast cancer resistant protein (BCRP) substrates, irinotecan, topotecan, methotrexate, imatinib, and lapatinib
  • Sustained, poorly controlled arterial hypertension or hypotension at baseline, defined as mean BP ≥ 180/110 mmHg or systolic BP \< 95 mmHg, respectively
  • Severe rhythm or conduction disorder (e.g., HR \< 50 or > 110 bpm, atrial fibrillation or flutter, prolonged QT > 500 msec, second or third degree atrioventricular [AV] block)
  • New York Heart Association Class III or IV congestive heart failure
  • Severe hepatic insufficiency (defined as alanine aminotransferase [ALT], aspartate aminotransferase [AST], or gamma-glutamyl transferase > 3 x the upper limit of norma [ULN], total bilirubin > 2 mg/dL, or Child-Pugh B or C) or active hepatitis in the investigator's opinion
  • An ongoing SAE from Study 16208 that is assessed as related to study drug
  • Alcohol or drug abuse
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    Molidustat (BAY85-3934)

    Drug: Molidustat (BAY85-3934)

  • Active comparator
    Epoetin alfa/beta

    Biological: Epoetin alfa/beta

Interventions

  • DrugMolidustat (BAY85-3934)

    Subjects will continue with the same treatment they were receiving in the parent study (16208). BAY85-3934 will be administered daily as oral tablets. Dose assessments will be made every 4 (± 1) weeks. At the scheduled visits, the dose may be titrated on an individualized basis taking into account the subject's Hb response and the tolerability of the previous dose. Total treatment time is up to 36 months. Planned doses include 15, 25, 50, 75, 100, and 150 mg once daily.

  • BiologicalEpoetin alfa/beta

    Subjects will continue with the same treatment they were receiving in the parent study (16208). Epoetin alfa / beta will be administered as intravenous (IV) or subcutaneous (SC) injections per individual subject regimen according to the local label. Dose assessments will be made every 4 (± 1) weeks. At the scheduled visits,dose may be titrated on an individualized basis taking into account the subject's Hb response and the tolerability of the previous dose.Total treatment time is up to 36 months.

06

What researchers measure

Primary outcomes

  1. Change in local laboratory hemoglobin level from baseline

    Time frame: Baseline up to 36 months

  2. Number of participants with serious adverse events as a measure of safety and tolerability

    Time frame: Up to 36 months

Secondary outcomes

  1. Maintenance in hemoglobin target range (10.0 to 11.0 g/dL)

    Time frame: Up to 36 months

  2. Maintenance in hemoglobin target range (9.5 to 11.5 g/dL)

    Time frame: Up to 36 months

  3. Duration of treatment exposure

    Time frame: Up to 36 months

  4. Number of subjects requiring titration of dose

    Time frame: Up to 36 months

  5. Change of reticulocyte count from baseline of this study

    Time frame: Baseline up to 36 months

  6. Change of reticulocyte count from baseline of study 16208

    Time frame: Baseline up to 36 months

  7. Change of red blood cell count from baseline of this study

    Time frame: Baseline up to 36 months

  8. Change of red blood cell count from baseline of study 16208

    Time frame: Baseline up to 36 months

  9. Change of hematocrit from baseline of this study

    Time frame: Baseline up to 36 months

  10. Change of hematocrit from baseline of study 16208

    Time frame: Baseline up to 36 months

  11. Change of central laboratory hemoglobin level from baseline of this study

    Time frame: Baseline up to 36 months

  12. Change of central laboratory hemoglobin level from baseline of study 16208

    Time frame: Baseline up to 36 months

07

Study locations

26 sites
  • Azusa, California 91702, United States
  • Long Beach, California 90813, United States
  • Lynwood, California 90262, United States
  • Northridge, California 91324, United States
  • San Dimas, California 91773, United States
  • Whittier, California 90602, United States
  • Whittier, California 90606, United States
  • New Port Richey, Florida 34652, United States
  • Pembroke Pines, Florida 33028, United States
  • Detroit, Michigan 48202, United States
  • Creve Coeur, Missouri 63141, United States
  • Buffalo, New York 14215, United States
  • Cincinnati, Ohio 45206, United States
  • Toledo, Ohio 43615, United States
  • Oklahoma City, Oklahoma 73116, United States
  • Nashville, Tennessee 37212-8150, United States
  • Fort Worth, Texas 76104, United States
  • Fort Worth, Texas 76105, United States
  • Fort Worth, Texas 76164, United States
  • Grand Prairie, Texas 75050, United States
  • Houston, Texas 77004, United States
  • Houston, Texas 77091, United States
  • Mansfield, Texas 76063, United States
  • Muroran, Hokkaido 050-0083, Japan
  • Kuwana, Mie 511-0061, Japan
  • Kyoto, 607-8116, Japan
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02064426
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Feb 17, 2014
Start date
Mar 13, 2014
Primary completion
Oct 19, 2016
Completion
Nov 16, 2016
Last update
Sep 20, 2019

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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