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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

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Bayer

Status

Active, not recruiting

Conditions

Renal Anemia

Treatments

Drug: Molidustat (Musredo, BAY85-3934)

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

1,081 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

1,081 participants in 1 patient group

Molidustat
Description:
Participants diagnosed with renal anemia treated with Molidustat at the discretion of investigators
Treatment:
Drug: Molidustat (Musredo, BAY85-3934)

Trial contacts and locations

1

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Central trial contact

Bayer Clinical Trials Contact

Data sourced from clinicaltrials.gov

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