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

Renal Anemia Clinical Trial

Official title:

Long-term Special Drug Use Investigation of Molidustat for Patients With Renal Anemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04899661
• Other study ID #: 21319
• Status: Recruiting
• Start date: August 6, 2021
• Est. completion date: September 30, 2027

Study information

• Verified date: April 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: September 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Renal Anemia

Intervention

Drug:
• Molidustat (Musredo, BAY85-3934)
Tablets, administered orally at the discretion of investigators

Locations

Country	Name	City	State
Japan	Many facilities	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Absolute changes of Hemoglobin (Hb) levels from the baseline		Up to approximately 24 months
Secondary	Percentage changes of Hemoglobin (Hb) levels from the baseline		Up to approximately 24 months
Secondary	Absolute changes of Hb levels from baseline in sub-group analysis	By patient background	Up to approximately 24 months
Secondary	Percentage changes of Hb levels from baseline in sub-group analysis	By patient background	Up to approximately 24 months
Secondary	Time course of Hb levels from the baseline		Up to approximately 24 months
Secondary	Proportion of participants with Hb level within target range		Up to approximately 24 months