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A Study to Learn More About the Long-term Safety and Effectiveness of Molidustat as a Treatment for Japanese Men and Women With Renal Anemia

NCT ID: NCT04899661

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1081 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-06

Study Completion Date

2027-09-30

Brief Summary

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In this study, the researchers want to learn more about the safety and effectiveness of Molidustat in Japanese men and women who have renal anemia, a condition in which the kidneys do not make enough of a hormone that helps the body make new red blood cells.

In previous clinical trials with a small number of participants, several important adverse events were observed. The researchers in this study want to know how many patients also have these adverse events under the real world, and if the number of the red blood cells will be increased after the treatment of Molidustat.

The researchers will collect the participants' health information from their medical records and their regular check-ups for up to 2 years. The data from this study will be submitted to the health authority in Japan in accordance with the local regulation.

Detailed Description

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Conditions

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Renal Anemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Molidustat

Participants diagnosed with renal anemia treated with Molidustat at the discretion of investigators

Molidustat (Musredo, BAY85-3934)

Intervention Type DRUG

Tablets, administered orally at the discretion of investigators

Interventions

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Molidustat (Musredo, BAY85-3934)

Tablets, administered orally at the discretion of investigators

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female or male participants with a diagnosis of renal anemia
* Decision to initiate treatment with Molidustat was made as per investigator's routine treatment practice
* Molidustat naïve participants (with including the participants treated within three months before the contracted date at each site)
* Signed informed consent

Exclusion Criteria

\- Contra-indications according to the local marketing authorization
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Many facilities

Multiple Locations, , Japan

Site Status

Countries

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Japan

Other Identifiers

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21319

Identifier Type: -

Identifier Source: org_study_id