Trial Condition(s):
Renal anemia
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
Bayer Identifier:
21319
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many facilities Many locations, Japan | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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:
1
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 patientsTimeframe: 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 patientsTimeframe: 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)"Timeframe: Up to approximately 24 months
- Absolute changes of Hemoglobin (Hb) levels from the baselineTimeframe: Up to approximately 24 months
- Percentage changes of Hemoglobin (Hb) levels from the baselineTimeframe: Up to approximately 24 months
- Absolute changes of Hb levels from baseline in sub-group analysisBy patient backgroundTimeframe: Up to approximately 24 months
- Percentage changes of Hb levels from baseline in sub-group analysisBy patient backgroundTimeframe: Up to approximately 24 months
- Time course of Hb levels from the baselineTimeframe: Up to approximately 24 months
- Proportion of participants with Hb level within target rangeTimeframe: Up to approximately 24 months
Additional Information
Not Available
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