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

NCT04899661 | Active Not Recruiting

• 1 other identifier: 21319
• Study Type: observational
• Target: 1,081
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Anemia

Outcome Measures

Primary Outcomes (1)

• Incidence of safety events

  Adverse Events/Adverse Drug Reactions including thromboembolism, hypertension, malignant tumor retinal hemorrhage, Major Adverse Cardiovascular Events (MACE) without thromboembolism, Interstitial lung disease (ILD) and Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD) in renal anemia patients

  Up to approximately 24 months

Secondary Outcomes (8)

• Incidence of safety events in dialysis and non-dialysis participants

  Up to approximately 24 months

• Incidence of safety events (important identified risk and important potential risk) by patient background

  Up to approximately 24 months

• Absolute changes of Hemoglobin (Hb) levels from the baseline

  Up to approximately 24 months

• Percentage changes of Hemoglobin (Hb) levels from the baseline

  Up to approximately 24 months

• Absolute changes of Hb levels from baseline in sub-group analysis

  Up to approximately 24 months

Study Arms (1)

Molidustat

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

Drug: Molidustat (Musredo, BAY85-3934)

Interventions

Molidustat (Musredo, BAY85-3934) DRUG

Tablets, administered orally at the discretion of investigators

Molidustat

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with a diagnosis of renal anemia and have been prescribed Molidustat in accordance with the product label

You may qualify if:

• 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

You may not qualify if:

• \- Contra-indications according to the local marketing authorization

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many facilities

Multiple Locations, Japan

Location

MeSH Terms

Interventions

molidustat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 24, 2021
• Study Start: August 6, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)