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

Study Overview
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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.

Official Title
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Long-term Special Drug Use Investigation of Molidustat for Patients With Renal Anemia

Conditions
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Renal Anemia

Intervention / Treatment
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* Drug: Molidustat (Musredo, BAY85-3934)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Molidustat<br>Participants diagnosed with renal anemia treated with Molidustat at the discretion of investigators | Drug: Molidustat (Musredo, BAY85-3934)<br>* Tablets, administered orally at the discretion of investigators<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of safety events in dialysis and non-dialysis participants | 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 | 
| Incidence of safety events (important identified risk and important potential risk) by patient background | Important identified risk: Thromboembolism and Hypertension Important potential risk: Malignant tumor, Retinal hemorrhage, Major Adverse Cardiovascular Events (MACE) without thromboembolism, Interstitial lung disease(ILD) and Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD) | 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 | By patient background | Up to approximately 24 months | 
| Percentage changes of Hb levels from baseline in sub-group analysis | By patient background | Up to approximately 24 months | 
| Time course of Hb levels from the baseline |  | Up to approximately 24 months | 
| Proportion of participants with Hb level within target range |  | Up to approximately 24 months |