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
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
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.
Study Type: Observational
Estimated Enrollment: 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Special Drug Use Investigation of Molidustat for Patients With Renal Anemia
Actual Study Start Date: August 6, 2021
Estimated Primary Completion Date: June 30, 2026
Estimated Study Completion Date: September 30, 2026
Group/Cohort:
- Molidustat (Participants diagnosed with renal anemia treated with Molidustat at the discretion of investigators)
| Category | Value |
|---|---|
| Study type(s) | Observational |
| Estimated enrolment | 1500 |
| Actual Study start date | 06 August 2021 |
| Estimated Study Completion Date | 30 September 2026 |