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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Renal Anemia
• Intervention / Treatment: Drug: Molidustat (Musredo, BAY85-3934)

• Study Type: Observational
• Enrollment (Actual): 1081

Contacts and Locations

Study Locations

• Japan
  • Multiple Locations, Japan
    • Many facilities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Molidustat; Participants diagnosed with renal anemia treated with Molidustat at the discretion of investigators	Drug: Molidustat (Musredo, BAY85-3934); Tablets, administered orally at the discretion of investigators

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)"	Up to approximately 24 months
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	By patient background	Up to approximately 24 months
Percentage changes of Hb levels from baseline in sub-group analysis	By patient background	Up to approximately 24 months
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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; molidustat
• Other Study ID Numbers: 21319 (Other Identifier: City of Hope Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No