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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 (DIALOGUE5)

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ClinicalTrials.gov Identifier: NCT02064426
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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.

Condition or disease Intervention/treatment Phase
Anemia Renal Insufficiency, Chronic Drug: Molidustat (BAY85-3934) Biological: Epoetin alfa/beta Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 13, 2014
Actual Primary Completion Date : October 19, 2016
Actual Study Completion Date : November 16, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Molidustat (BAY85-3934) Drug: Molidustat (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.

Active Comparator: Epoetin alfa/beta Biological: Epoetin 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064426


Locations
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United States, California
Azusa, California, United States, 91702
Long Beach, California, United States, 90813
Lynwood, California, United States, 90262
Northridge, California, United States, 91324
San Dimas, California, United States, 91773
Whittier, California, United States, 90602
Whittier, California, United States, 90606
United States, Florida
New Port Richey, Florida, United States, 34652
Pembroke Pines, Florida, United States, 33028
United States, Michigan
Detroit, Michigan, United States, 48202
United States, Missouri
Creve Coeur, Missouri, United States, 63141
United States, New York
Buffalo, New York, United States, 14215
United States, Ohio
Cincinnati, Ohio, United States, 45206
Toledo, Ohio, United States, 43615
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73116
United States, Tennessee
Nashville, Tennessee, United States, 37212-8150
United States, Texas
Fort Worth, Texas, United States, 76104
Fort Worth, Texas, United States, 76105
Fort Worth, Texas, United States, 76164
Grand Prairie, Texas, United States, 75050
Houston, Texas, United States, 77004
Houston, Texas, United States, 77091
Mansfield, Texas, United States, 76063
Japan
Muroran, Hokkaido, Japan, 050-0083
Kuwana, Mie, Japan, 511-0061
Kyoto, Japan, 607-8116
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02064426    
Other Study ID Numbers: 16209
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Keywords provided by Bayer:
Anemia of CKD on dialysis
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Anemia
Hematologic Diseases
Urologic Diseases
Epoetin Alfa
Hematinics