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AnemiaPhase 2DIALOGUE4NCT01975818

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

A Phase 2 study testing Molidustat (BAY 85-3934) and Epoetin alfa/beta in people with Anemia and Renal Insufficiency, Chronic, run by Bayer at 35 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia, Renal Insufficiency, Chronic
What is being tested?
Molidustat (BAY 85-3934) and Epoetin alfa/beta
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
35 sitesin 2 countries
Study dates
28 Oct 2013to 15 Dec 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • - 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

35 sites in 2 countries.

35 sites in 2 countries

United States30 sites

  • Study site

    Azusa, California, 91702

  • Study site

    Brooklyn, New York, 11212

  • Study site

    Buffalo, New York, 14215

  • Study site

    Cincinnati, Ohio, 45206

  • Study site

    Creve Coeur, Missouri, 63141

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Detroit, Michigan, 48236

  • Study site

    Eatontown, New Jersey, 07724

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Fort Worth, Texas, 76105

  • Study site

    Fort Worth, Texas, 76164

  • Study site

    Fresh Meadows, New York, 11365

  • Study site

    Grand Prairie, Texas, 75050

  • Study site

    Houston, Texas, 77004

  • Study site

    Houston, Texas, 77091

  • Study site

    Long Beach, California, 90813

  • Study site

    Los Angeles, California, 90025

  • Study site

    Lynwood, California, 90262

  • Study site

    Mansfield, Texas, 76063

  • Study site

    Nashville, Tennessee, 37212-8150

  • Study site

    New Port Richey, Florida, 34652

  • Study site

    Northridge, California, 91324

  • Study site

    Oklahoma City, Oklahoma, 73116

  • Study site

    Pembroke Pines, Florida, 33028

  • Study site

    San Antonio, Texas, 78215

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Dimas, California, 91773

  • Study site

    Toledo, Ohio, 43615

  • Study site

    Whittier, California, 90602

  • Study site

    Whittier, California, 90606

Other trials in United States

Japan5 sites

  • Study site

    Himeji, Hyōgo, 670-0947

  • Study site

    Kuwana, Mie-ken, 511-0061

  • Study site

    Kyoto, 607-8116

  • Study site

    Muroran, Hokkaido, 050-0083

  • Study site

    Nagano, 388-8004

Other trials in Japan

About this study

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

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

Being tested
Molidustat (BAY 85-3934), Epoetin alfa/beta
Keywords
Anemia of CKD on dialysis
Medical subject headings
Anemia, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Molidustat (BAY 85-3934)Drug

    Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets

  • Epoetin alfa/betaBiological

Study groups in NCT01975818
Study groupRoleWhat they receive
Molidustat (BAY 85-3934)(25mg)ExperimentalStarting 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.
Receives: Drug: Molidustat (BAY 85-3934)
Molidustat (BAY 85-3934)(50mg)ExperimentalStarting 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.
Receives: Drug: Molidustat (BAY 85-3934)
Molidustat (BAY 85-3934) (75mg)ExperimentalStarting 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.,
Receives: Drug: Molidustat (BAY 85-3934)
Molidustat (BAY 85-3934) (150mg)ExperimentalStarting 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
Receives: Drug: Molidustat (BAY 85-3934)
Epoetin alfa/betaActive comparatorStarting 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.
Receives: Biological: Epoetin alfa/beta

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period

    Measured: Baseline and weeks 14 to 17

Secondary outcomes (8)

  1. Mean of the hemoglobin (Hb) levels in the target range (10.0 to 11.0 g/dL)

    Measured: From week 14 to 17

  2. Mean of the hemoglobin levels in the target range (9.5 to 11.5 g/dL)

    Measured: From week 14 to 17

  3. Change from baseline in Hb during active treatment

    Measured: Baseline and weeks 14 to 17

  4. Number of patients with hemoglobin levels outside the target range

    Measured: From week 14 to 17

  5. Dose level in the evaluation period

    Measured: Up to 16 weeks

  6. Duration of exposure on each dose level

    Measured: Up to 16 weeks

  7. Number of subjects requiring titration of dose

    Measured: Up to 16 weeks

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

    Measured: Up to 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2013 (estimated)
  2. Study start28 Oct 2013
  3. Primary completion23 Oct 2015
  4. Study completion15 Dec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01975818
Sponsor's protocol ID
16208
Acronym
DIALOGUE4
Status last verified
Sep 2019
First submitted
18 Oct 2013
Last updated
20 Sep 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

    PubMed 36005278

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Molidustat (BAY 85-3934) and Epoetin alfa/beta in people with Anemia and Renal Insufficiency, Chronic, run by Bayer at 35 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01975818, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.

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