do_not_disturb_altRecruitment Complete

Renal anemia

Bayer Identifier:

21319

ClinicalTrials.gov Identifier:

NCT04899661

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

20 - N/A
  • - 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
  • - Contra-indications according to the local marketing authorization

Trial summary

Enrollment Goal
1081
Trial Dates
August 2021 - September 2027
Phase
Phase 4
Could I Receive a placebo
No
Products
Musredo (Molidustat, BAY85-3934)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
Many facilitiesMany locations, Japan

Primary Outcome

  • 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
    date_rangeTime Frame:
    Up to approximately 24 months

Secondary Outcome

  • 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
    date_rangeTime Frame:
    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)"
    date_rangeTime Frame:
    Up to approximately 24 months
  • Absolute changes of Hemoglobin (Hb) levels from the baseline
    date_rangeTime Frame:
    Up to approximately 24 months
  • Percentage changes of Hemoglobin (Hb) levels from the baseline
    date_rangeTime Frame:
    Up to approximately 24 months
  • Absolute changes of Hb levels from baseline in sub-group analysis
    By patient background
    date_rangeTime Frame:
    Up to approximately 24 months
  • Percentage changes of Hb levels from baseline in sub-group analysis
    By patient background
    date_rangeTime Frame:
    Up to approximately 24 months
  • Time course of Hb levels from the baseline
    date_rangeTime Frame:
    Up to approximately 24 months
  • Proportion of participants with Hb level within target range
    date_rangeTime Frame:
    Up to approximately 24 months

Trial design

Long-term Special Drug Use Investigation of Molidustat for Patients with Renal Anemia
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A