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

Bayer

Status: Active, not recruiting

Conditions: Renal Anemia

Treatments: Drug: Molidustat (Musredo, BAY85-3934)

Study type: Observational

Funder types: Industry

Identifiers

NCT04899661

21319

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)