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NCT Number: 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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Renal Anemia

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many facilities

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Molidustat (Musredo, BAY85-3934)

Drug

Tablets, administered orally at the discretion of investigators

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of safety events in dialysis and non-dialysis participants

    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

  2. Incidence of safety events (important identified risk and important potential risk) by patient background

    Time frame: Up to approximately 24 months

    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)"

  3. Absolute changes of Hemoglobin (Hb) levels from the baseline

    Time frame: Up to approximately 24 months

  4. Percentage changes of Hemoglobin (Hb) levels from the baseline

    Time frame: Up to approximately 24 months

  5. Absolute changes of Hb levels from baseline in sub-group analysis

    Time frame: Up to approximately 24 months

    By patient background

  6. Percentage changes of Hb levels from baseline in sub-group analysis

    Time frame: Up to approximately 24 months

    By patient background

  7. Time course of Hb levels from the baseline

    Time frame: Up to approximately 24 months

  8. Proportion of participants with Hb level within target range

    Time frame: Up to approximately 24 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
May 24, 2021
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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