do_not_disturb_altRecruitment Complete
Renal anemia
Bayer Identifier:
21319
ClinicalTrials.gov Identifier:
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.
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
AllAge
20 - N/ATrial summary
Enrollment Goal
1081Trial Dates
August 2021 - September 2027Phase
Phase 4Could I Receive a placebo
NoProducts
Musredo (Molidustat, BAY85-3934)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Active, not recruiting | Many facilities | Many locations, Japan |
Primary Outcome
- Incidence of safety eventsAdverse 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 patientsdate_rangeTime Frame:Up to approximately 24 months
Secondary Outcome
- Incidence of safety events in dialysis and non-dialysis participantsAdverse 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 patientsdate_rangeTime Frame:Up to approximately 24 months
- Incidence of safety events (important identified risk and important potential risk) by patient backgroundImportant 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 baselinedate_rangeTime Frame:Up to approximately 24 months
- Percentage changes of Hemoglobin (Hb) levels from the baselinedate_rangeTime Frame:Up to approximately 24 months
- Absolute changes of Hb levels from baseline in sub-group analysisBy patient backgrounddate_rangeTime Frame:Up to approximately 24 months
- Percentage changes of Hb levels from baseline in sub-group analysisBy patient backgrounddate_rangeTime Frame:Up to approximately 24 months
- Time course of Hb levels from the baselinedate_rangeTime Frame:Up to approximately 24 months
- Proportion of participants with Hb level within target rangedate_rangeTime Frame:Up to approximately 24 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A