Clinical trial NCT04899661: 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
Official title: Long-term Special Drug Use Investigation of Molidustat for Patients With Renal Anemia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Renal Anemia
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2021-05-24
Enrollment: 1081
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a diagnosis of renal anemia and have been prescribed Molidustat in accordance with the product label

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.


Eligibility criteria: 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 outcomes:
measure: Incidence of safety events
timeFrame: Up to approximately 24 months
Secondary outcomes:
measure: Incidence of safety events in dialysis and non-dialysis participants
timeFrame: Up to approximately 24 months
measure: Incidence of safety events (important identified risk and important potential risk) by patient background
timeFrame: Up to approximately 24 months
measure: Absolute changes of Hemoglobin (Hb) levels from the baseline
timeFrame: Up to approximately 24 months
measure: Percentage changes of Hemoglobin (Hb) levels from the baseline
timeFrame: Up to approximately 24 months
measure: Absolute changes of Hb levels from baseline in sub-group analysis
timeFrame: Up to approximately 24 months
measure: Percentage changes of Hb levels from baseline in sub-group analysis
timeFrame: Up to approximately 24 months
measure: Time course of Hb levels from the baseline
timeFrame: Up to approximately 24 months
measure: Proportion of participants with Hb level within target range
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Many facilities
Study officials:
References: