En undersøgelse for at lære mere om den langsigtede sikkerhed og effektivitet af Molidustat som en behandling for japanske mænd og kvinder med nyreanæmi
Langtidsundersøgelse af særlig lægemiddelbrug af Molidustat til patienter med nyreanæmi
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Many Locations, Japan
- Many locations
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Participants with a diagnosis of renal anemia and have been prescribed Molidustat in accordance with the product label
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Molidustat
Participants diagnosed with renal anemia treated with Molidustat at the discretion of investigators |
Tablets, administered orally at the discretion of investigators |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of safety events
Tidsramme: 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 |
Up to approximately 24 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Absolutte ændringer af hæmoglobin (Hb) niveauer fra baseline
Tidsramme: Op til cirka 24 måneder
|
Op til cirka 24 måneder
|
|
|
Procentvise ændringer af hæmoglobin (Hb) niveauer fra baseline
Tidsramme: Op til cirka 24 måneder
|
Op til cirka 24 måneder
|
|
|
Tidsforløb for Hb-niveauer fra basislinjen
Tidsramme: Op til cirka 24 måneder
|
Op til cirka 24 måneder
|
|
|
Andel af deltagere med Hb-niveau inden for målområdet
Tidsramme: Op til cirka 24 måneder
|
Op til cirka 24 måneder
|
|
|
Incidence of safety events in dialysis and non-dialysis participants
Tidsramme: 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 |
Up to approximately 24 months
|
|
Incidence of safety events (important identified risk and important potential risk) by patient background
Tidsramme: 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)" |
Up to approximately 24 months
|
|
Absolute changes of Hb levels from baseline in sub-group analysis
Tidsramme: Up to approximately 24 months
|
By patient background |
Up to approximately 24 months
|
|
Percentage changes of Hb levels from baseline in sub-group analysis
Tidsramme: Up to approximately 24 months
|
By patient background |
Up to approximately 24 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 21319
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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