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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)

Primary Purpose

Anemia, Renal Insufficiency, Chronic

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Molidustat (BAY85-3934)

Epoetin alfa/beta

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia of CKD on dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Molidustat (BAY85-3934)

Epoetin alfa/beta

Arm Description

Outcomes

Primary Outcome Measures

Change in local laboratory hemoglobin level from baseline

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

Secondary Outcome Measures

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

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

Duration of treatment exposure

Number of subjects requiring titration of dose

Change of reticulocyte count from baseline of this study

Change of reticulocyte count from baseline of study 16208

Change of red blood cell count from baseline of this study

Change of red blood cell count from baseline of study 16208

Change of hematocrit from baseline of this study

Change of hematocrit from baseline of study 16208

Change of central laboratory hemoglobin level from baseline of this study

Change of central laboratory hemoglobin level from baseline of study 16208

Full Information

NCT ID

NCT02064426

First Posted

February 14, 2014

Last Updated

September 17, 2019

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT02064426

Brief Title

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

Acronym

DIALOGUE5

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

March 13, 2014 (Actual)

Primary Completion Date

October 19, 2016 (Actual)

Study Completion Date

November 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, Renal Insufficiency, Chronic

Keywords

Anemia of CKD on dialysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Molidustat (BAY85-3934)

Arm Type

Experimental

Arm Title

Epoetin alfa/beta

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Molidustat (BAY85-3934)

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Epoetin alfa/beta

Intervention Description

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 Measure Information:

Title

Change in local laboratory hemoglobin level from baseline

Time Frame

Baseline up to 36 months

Title

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

Time Frame

Up to 36 months

Secondary Outcome Measure Information:

Title

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

Time Frame

Up to 36 months

Title

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

Time Frame

Up to 36 months

Title

Duration of treatment exposure

Time Frame

Up to 36 months

Title

Number of subjects requiring titration of dose

Time Frame

Up to 36 months

Title

Change of reticulocyte count from baseline of this study

Time Frame

Baseline up to 36 months

Title

Change of reticulocyte count from baseline of study 16208

Time Frame

Baseline up to 36 months

Title

Change of red blood cell count from baseline of this study

Time Frame

Baseline up to 36 months

Title

Change of red blood cell count from baseline of study 16208

Time Frame

Baseline up to 36 months

Title

Change of hematocrit from baseline of this study

Time Frame

Baseline up to 36 months

Title

Change of hematocrit from baseline of study 16208

Time Frame

Baseline up to 36 months

Title

Change of central laboratory hemoglobin level from baseline of this study

Time Frame

Baseline up to 36 months

Title

Change of central laboratory hemoglobin level from baseline of study 16208

Time Frame

Baseline up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Azusa

State/Province

California

ZIP/Postal Code

91702

Country

United States

City

Long Beach

State/Province

California

ZIP/Postal Code

90813

Country

United States

City

Lynwood

State/Province

California

ZIP/Postal Code

90262

Country

United States

City

Northridge

State/Province

California

ZIP/Postal Code

91324

Country

United States

City

San Dimas

State/Province

California

ZIP/Postal Code

91773

Country

United States

City

Whittier

State/Province

California

ZIP/Postal Code

90602

Country

United States

City

Whittier

State/Province

California

ZIP/Postal Code

90606

Country

United States

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33028

Country

United States

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

City

Creve Coeur

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

City

Buffalo

State/Province

New York

ZIP/Postal Code

14215

Country

United States

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45206

Country

United States

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43615

Country

United States

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73116

Country

United States

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212-8150

Country

United States

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76105

Country

United States

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76164

Country

United States

City

Grand Prairie

State/Province

Texas

ZIP/Postal Code

75050

Country

United States

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

City

Houston

State/Province

Texas

ZIP/Postal Code

77091

Country

United States

City

Mansfield

State/Province

Texas

ZIP/Postal Code

76063

Country

United States

City

Muroran

State/Province

Hokkaido

ZIP/Postal Code

050-0083

Country

Japan

City

Kuwana

State/Province

Mie

ZIP/Postal Code

511-0061

Country

Japan

City

Kyoto

ZIP/Postal Code

607-8116

Country

Japan

12. IPD Sharing Statement

Links:

URL

http://clinicaltrials.bayer.com/

Description

Click here to find results for studies related to Bayer products

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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

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