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Clinical Trials in Japan / NCT04899661
Active, not recruiting Observational

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 · tracked via the Priya Life Science Japan tracker
Sponsor
Bayer
Phase
Observational
Started
2021-08-06
Last updated
2026-10-20

Condition(s) studied

Renal Anemia

Investigational drug(s) / intervention(s)

Molidustat (Musredo, BAY85-3934)

Molidustat (Musredo, BAY85-3934): Tablets, administered orally at the discretion of investigators

Study 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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of safety events — Up to approximately 24 months
    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

Trial sites (1)

FacilityCityRegionStatus
Many locations Multiple Locations Japan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04899661 on ClinicalTrials.gov ↗ ← All trials in Japan