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
- Registration Number
- NCT04899661
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- 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
- Contra-indications according to the local marketing authorization
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Molidustat Molidustat (Musredo, BAY85-3934) Participants diagnosed with renal anemia treated with Molidustat at the discretion of investigators
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Absolute changes of Hemoglobin (Hb) levels from the baseline Up to approximately 24 months Incidence of safety events in dialysis and non-dialysis participants 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
Percentage changes of Hb levels from baseline in sub-group analysis Up to approximately 24 months By patient background
Time course of Hb levels from the baseline Up to approximately 24 months Incidence of safety events (important identified risk and important potential risk) by patient background Up to approximately 24 months 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)"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 By patient background
Proportion of participants with Hb level within target range Up to approximately 24 months
Trial Locations
- Locations (1)
Many facilities
🇯🇵Multiple Locations, Japan