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Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934 (DIALOGUE4)

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ClinicalTrials.gov Identifier: NCT01975818
Recruitment Status : Completed
First Posted : November 5, 2013
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
Evaluate efficacy and safety of 16 weeks of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta as measured by hemoglobin (Hb) levels. Fixed starting doses of 25, 50,75 and 150 mg of BAY85-3934 titrated at the scheduled dose control visits. Titration will be based on the subject's Hb response and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg/day

Condition or disease Intervention/treatment Phase
Anemia Renal Insufficiency, Chronic Drug: Molidustat (BAY 85-3934) Biological: Epoetin alfa/beta Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel Group, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Epoetin Alfa / Beta) in the Maintenance Treatment of Subjects With Anemia Associated With Chronic Kidney Disease Who Are on Dialysis and on Treatment With an Erythropoiesis-stimulating Agent in the United States and Japan
Actual Study Start Date : October 28, 2013
Actual Primary Completion Date : October 23, 2015
Actual Study Completion Date : December 15, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Molidustat (BAY 85-3934)(25mg)
Starting dose of 25 mg of BAY85-3934 as once-daily oral tablets. Regular titrations at dose control visits. Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily.
Drug: Molidustat (BAY 85-3934)
Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets

Experimental: Molidustat (BAY 85-3934)(50mg)
Starting dose of 50 mg of BAY85-3934 as once-daily oral tablets. Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily.
Drug: Molidustat (BAY 85-3934)
Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets

Experimental: Molidustat (BAY 85-3934) (75mg)
Starting dose of 75 mg of BAY85-3934 as once-daily oral tablets. Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily.,
Drug: Molidustat (BAY 85-3934)
Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets

Experimental: Molidustat (BAY 85-3934) (150mg)
Starting dose of 150 mg of BAY85-3934 as once-daily oral tablets. Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100, 150 and 200 mg once daily
Drug: Molidustat (BAY 85-3934)
Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets

Active Comparator: Epoetin alfa/beta
Starting dose at the subject's current weekly dose. Administered IV or SC 3 times per week. Doses will be titrated at the scheduled dose control visits according to the local label. Titration will be based on the subject's Hb response and tolerability of the prior dose. Epoetin alfa may be administered in either the United States (US) or Japan; epoetin beta will only be administered in Japan.
Biological: Epoetin alfa/beta



Primary Outcome Measures :
  1. Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period [ Time Frame: Baseline and weeks 14 to 17 ]

Secondary Outcome Measures :
  1. Mean of the hemoglobin (Hb) levels in the target range (10.0 to 11.0 g/dL) [ Time Frame: From week 14 to 17 ]
  2. Mean of the hemoglobin levels in the target range (9.5 to 11.5 g/dL) [ Time Frame: From week 14 to 17 ]
  3. Change from baseline in Hb during active treatment [ Time Frame: Baseline and weeks 14 to 17 ]
  4. Number of patients with hemoglobin levels outside the target range [ Time Frame: From week 14 to 17 ]
  5. Dose level in the evaluation period [ Time Frame: Up to 16 weeks ]
  6. Duration of exposure on each dose level [ Time Frame: Up to 16 weeks ]
  7. Number of subjects requiring titration of dose [ Time Frame: Up to 16 weeks ]
  8. Number of participants with serious adverse events as a measure of safety and tolerability [ Time Frame: Up to 16 weeks ]


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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 subjects will have a diagnosis of anemia associated with CKD(chronic kidney disease).
  • Women without childbearing potential
  • Male or female subject ≥ 18 years of age with anemia of CKD at screening
  • On dialysis, defined as regular long-term hemodialysis, with the same modality of dialysis for ≥ 3 months before randomization
  • Dialysis vascular access via native arteriovenous fistula, synthetic graft, long-term catheters, or long-term tunneled catheters
  • Treated with epoetin alfa (US or Japan) or epoetin beta (Japan) via intravenous (IV) or subcutaneous (SC) route, on stable dosing defined as a < 50% change from the maximum prescribed weekly dose with no change in the prescribed frequency during the last 8 weeks prior to randomization
  • At least one kidney
  • Mean screening Hb concentration 9.0 to 11.5 g/dL inclusive (mean of all local laboratory Hb measurements [at least 2 measurements must be taken ≥ 2 days apart] during the 4 week screening period, AND none of the measurements can be < 9.0 g/dL or > 12.0 g /dL
  • Serum ferritin levels ≥ 100 μg/L OR transferrin saturation ≥ 20% at screening. Iron substitution is allowed
  • Folate and vitamin B12 levels above the lower limit of normal. Supplementation is allowed
  • Exclusion Criteria:
  • Subjects with significant acute or chronic bleeding, such as overt gastrointestinal bleeding
  • Hereditary hemoglobinopathies (including, but not limited to, sickle cell disease, beta thalassemia, and thalassemia major) which may be the primary cause of anemia
  • Chronic lymphoproliferative diseases
  • Any allograft (including renal allograft) in place and on immunosuppressive therapy, or a scheduled kidney transplant within the next 16 weeks (being on a waiting list does not exclude the subject)
  • Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease)
  • Subjects treated with immuno- or myelosuppressive therapy within 8 weeks prior to randomization: e.g., everolimus, sirolimus, rituximab, azathioprine, mycophenolate mofetil, mycophenolic acid, cyclosporine,methotrexate, and tacrolimus, chemotherapeutic agents and other anticancer agents, and systemic steroids (except inhaled steroids) for 7 days
  • RBC-containing transfusion within 8 weeks before randomization
  • History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within the last 6 months from the initial screening visit
  • Sustained, poorly controlled arterial hypertension or hypotension at screening, defined as a mean BP ≥ 180/110 mmHg or systolic BP < 95 mmHg, respectively
  • Severe rhythm or conduction disorder (e.g., HR < 50 or > 110 bpm, atrial flutter, prolonged QT >500 msec, second or third degree atrioventricular [AV]block if not treated with a pacemaker)
  • 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 times the upper limit of normal [ULN], total bilirubin > 2 mg/dL, or Child-Pugh B or C) or active hepatitis in the investigator's opinion
  • A scheduled surgery that may be expected to lead to significant blood loss

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): NCT01975818


Locations
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United States, California
Azusa, California, United States, 91702
Long Beach, California, United States, 90813
Los Angeles, California, United States, 90025
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
Detroit, Michigan, United States, 48236
United States, Missouri
Creve Coeur, Missouri, United States, 63141
United States, New Jersey
Eatontown, New Jersey, United States, 07724
United States, New York
Brooklyn, New York, United States, 11212
Buffalo, New York, United States, 14215
Fresh Meadows, New York, United States, 11365
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
San Antonio, Texas, United States, 78215
San Antonio, Texas, United States, 78229
Japan
Muroran, Hokkaido, Japan, 050-0083
Himeji, Hyogo, Japan, 670-0947
Kuwana, Mie, Japan, 511-0061
Kyoto, Japan, 607-8116
Nagano, Japan, 388-8004
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: NCT01975818    
Other Study ID Numbers: 16208
First Posted: November 5, 2013    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