A Study to Learn More About the Long-term Safety and Effectiveness of Molidustat as a Treatment f… (NCT04899661) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
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
Japan1,081 participantsStarted 2021-08-06
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is specifically focused on long-term safety of molidustat for renal anemia — since it's primarily measuring how often safety events occur rather than how well it works, what does that mean for understanding the actual benefit-to-risk balance for someone in my situation?
2The trial is listed as 'active not recruiting,' which means they're no longer accepting new participants — is there any way I might still be considered, or is there a related or follow-up study involving molidustat that I could potentially discuss?
3Since this trial is enrolling Japanese patients specifically, does that mean the safety and effectiveness data may be more relevant to people of Japanese background, and how should I factor that into thinking about whether molidustat might be right for me?
4Molidustat works differently from traditional treatments like erythropoiesis-stimulating agents or iron therapy for renal anemia — how does my doctor weigh those established options against a newer agent like molidustat that is still being studied for long-term safety?
5If molidustat eventually becomes more widely available based on studies like this one, what would my doctor want to see in the long-term safety data before feeling comfortable recommending it as part of my renal anemia treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.