AzTrials
AzTrials

AnemiaPhase 2DIALOGUE5NCT02064426

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 study testing Molidustat (BAY85-3934) and Epoetin alfa/beta in people with Anemia and Renal Insufficiency, Chronic, run by Bayer at 26 sites in 2 countries.

Completed

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

Official record
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Trial 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. 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 (BAY85-3934) and Epoetin alfa/beta
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
26 sitesin 2 countries
Study dates
13 Mar 2014to 16 Nov 2016
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 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

26 sites in 2 countries.

26 sites in 2 countries

United States23 sites

  • Study site

    Azusa, California, 91702

  • Study site

    Buffalo, New York, 14215

  • Study site

    Cincinnati, Ohio, 45206

  • Study site

    Creve Coeur, Missouri, 63141

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Fort Worth, Texas, 76105

  • Study site

    Fort Worth, Texas, 76164

  • Study site

    Grand Prairie, Texas, 75050

  • Study site

    Houston, Texas, 77004

  • Study site

    Houston, Texas, 77091

  • Study site

    Long Beach, California, 90813

  • 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 Dimas, California, 91773

  • Study site

    Toledo, Ohio, 43615

  • Study site

    Whittier, California, 90602

  • Study site

    Whittier, California, 90606

Other trials in United States

Japan3 sites

  • Study site

    Kuwana, Mie-ken, 511-0061

  • Study site

    Kyoto, 607-8116

  • Study site

    Muroran, Hokkaido, 050-0083

Other trials in Japan

About this study

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

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.

Being tested
Molidustat (BAY85-3934), 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 (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/betaBiological

    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.

Study groups in NCT02064426
Study groupRoleWhat they receive
Molidustat (BAY85-3934)ExperimentalNot described
Receives: Drug: Molidustat (BAY85-3934)
Epoetin alfa/betaActive comparatorNot described
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

    Measured: Baseline up to 36 months

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

    Measured: Up to 36 months

Secondary outcomes (12)

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

    Measured: Up to 36 months

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

    Measured: Up to 36 months

  3. Duration of treatment exposure

    Measured: Up to 36 months

  4. Number of subjects requiring titration of dose

    Measured: Up to 36 months

  5. Change of reticulocyte count from baseline of this study

    Measured: Baseline up to 36 months

  6. Change of reticulocyte count from baseline of study 16208

    Measured: Baseline up to 36 months

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

    Measured: Baseline up to 36 months

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

    Measured: Baseline up to 36 months

  9. Change of hematocrit from baseline of this study

    Measured: Baseline up to 36 months

  10. Change of hematocrit from baseline of study 16208

    Measured: Baseline up to 36 months

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

    Measured: Baseline up to 36 months

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

    Measured: Baseline up to 36 months

Timeline

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

  1. First posted17 Feb 2014 (estimated)
  2. Study start13 Mar 2014
  3. Primary completion19 Oct 2016
  4. Study completion16 Nov 2016

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
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02064426
Sponsor's protocol ID
16209
Acronym
DIALOGUE5
Status last verified
Sep 2019
First submitted
14 Feb 2014
Last updated
20 Sep 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Molidustat (BAY85-3934) and Epoetin alfa/beta in people with Anemia and Renal Insufficiency, Chronic, run by Bayer at 26 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 4 inclusion and 9 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 26 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 (time frame: Baseline up to 36 months). The study lists 2 primary outcomes in all. 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 NCT02064426.

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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