Renal AnemiaNCT04899661
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
An observational study of Renal Anemia, run by Bayer at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Renal Anemia
- What is being tested?
- Molidustat (Musredo, BAY85-3934)
- Type of treatment
- Pill or oral medicine
- How many people
- 1,081 participants
- Where
- 1 siteJapan
- Study dates
- 6 Aug 2021to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with a diagnosis of renal anemia and have been prescribed Molidustat in accordance with the product label
Who may be able to join
- 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
Who cannot join
- Contra-indications according to the local marketing authorization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Special Drug Use Investigation of Molidustat for Patients 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.
- Conditions
- Renal Anemia
- Being tested
- Molidustat (Musredo, BAY85-3934)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molidustat (Musredo, BAY85-3934)Drug
Tablets, administered orally at the discretion of investigators
| Study group | Role | What they receive |
|---|---|---|
| Molidustat | Participants diagnosed with renal anemia treated with Molidustat at the discretion of investigators Receives: Drug: Molidustat (Musredo, BAY85-3934) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to approximately 24 months
Secondary outcomes (8)
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
Measured: 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)"
Measured: Up to approximately 24 months
Absolute changes of Hemoglobin (Hb) levels from the baseline
Measured: Up to approximately 24 months
Percentage changes of Hemoglobin (Hb) levels from the baseline
Measured: Up to approximately 24 months
Absolute changes of Hb levels from baseline in sub-group analysis
By patient background
Measured: Up to approximately 24 months
Percentage changes of Hb levels from baseline in sub-group analysis
By patient background
Measured: Up to approximately 24 months
Time course of Hb levels from the baseline
Measured: Up to approximately 24 months
Proportion of participants with Hb level within target range
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start6 Aug 2021
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal AnemiaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,081 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899661
- Sponsor's protocol ID
- 21319
- Status last verified
- 19 Oct 2026
- First submitted
- 20 May 2021
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Special Drug Use Investigation of Molidustat for Patients With Renal Anemia
- ClinicalTrials.gov ID
- NCT04899661
- Acronym / sponsor ID
- 21319
- Conditions
- Renal Anemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,081 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Molidustat | – | Drug: Molidustat (Musredo, BAY85-3934)Participants diagnosed with renal anemia treated with Molidustat at the discretion of investigators |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a diagnosis of renal anemia and have been prescribed Molidustat in accordance with the product label
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Contra-indications according to the local marketing authorization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molidustat (Musredo, BAY85-3934)Tablets, administered orally at the discretion of investigators | Drug | Molidustat |
Primary outcome
Incidence of safety events
Time frame: 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
8 secondary outcomes
Incidence of safety events in dialysis and non-dialysis participants
Time frame: Up to approximately 24 months
Incidence of safety events (important identified risk and important potential risk) by patient background
Time frame: Up to approximately 24 months
Absolute changes of Hemoglobin (Hb) levels from the baseline
Time frame: Up to approximately 24 months
Percentage changes of Hemoglobin (Hb) levels from the baseline
Time frame: Up to approximately 24 months
Absolute changes of Hb levels from baseline in sub-group analysis
Time frame: Up to approximately 24 months
Percentage changes of Hb levels from baseline in sub-group analysis
Time frame: Up to approximately 24 months
Time course of Hb levels from the baseline
Time frame: Up to approximately 24 months
Proportion of participants with Hb level within target range
Time frame: Up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Anemia, run by Bayer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of safety events (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.