Renal Anemia
Conditions
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.
Interventions
DRUGMolidustat (Musredo, BAY85-3934)
Tablets, administered orally at the discretion of investigators
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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)" |
| 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 | By patient background |
| 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 | — |
| Proportion of participants with Hb level within target range | Up to approximately 24 months | — |
Countries
Japan
Outcome results
None listed