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Completed

NCT Number: NCT02064426

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

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.

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Key information

Conditions

Anemia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Muroran, Hokkaido, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Molidustat (BAY85-3934)

Drug

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.

Epoetin alfa/beta

Biological

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.

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Controlled, Parallel Group, Open-label, Multicenter Extension Study to Investigate Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Epoetin Alfa / Beta) in the Long-term Treatment of Subjects With Anemia Associated With Chronic Kidney Disease Who Are on Dialysis in the United States and Japan

Acronym: DIALOGUE5

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 17, 2014
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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