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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS1000000006 | Registry Identifier | EUPAS |
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The main aim of this study is to assess the safety of maribavir in adults with severe CKD or comorbid ESRD including participants on artificial filtering of the kidney (dialysis) or the blood (hemodialysis).
In this study, already existing data will be collected from the participant's medical records. The study will only review data collected as part of the normal clinical routine and will not impact the standard medical care and treatment of participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants With Kidney Failure | The study cohort will comprise of participants aged 18 years or older treated with maribavir for a refractory CMV infection and who have severe CKD or comorbid ESRD including participants on peritoneal dialysis or hemodialysis. Data from eligible participants will be assessed from index date (Day 0: the day of initiation of the first maribavir treatment course during the eligibility period) until 7 days after the date of the end of supply of the last prescription of treatment or date of death or end of data availability, or treatment completion/discontinuation whichever occurs first. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | This is a non-interventional study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An AE is defined as any untoward medical occurrence (including a symptom or disease or an abnormal laboratory finding) in a participant or clinical investigation participants administered a medicinal product and which does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) is any event that results in: death; life-threatening event; requires inpatient hospitalization or results in prolongation of existing hospitalization; persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or a medically important event. | Time from index treatment date until 7 days after the date of the end of supply of the last prescription of treatment or date of death, whichever occurs first (up to 4 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events of Special Interest (AESIs) | An AESI is defined as AEs that will be specifically highlighted to the Investigator. AESIs are as follows: Immunosuppressant drug concentration level increased, tissue-invasive CMV disease, relapse or progression of the underlying disease for which the transplant was performed, taste disturbance (dysgeusia), Nausea, vomiting, diarrhea, invasive fungal or bacterial infections, graft-versus-host-disease (GVHD), leukopenia including neutropenia, lymphocytopenia, and low white blood cell (WBC) count, anemia including low hemoglobin and thrombocytopenia including low platelets count. |
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Inclusion Criteria:
Adults more than and equal to (≥) 18 years of age at index date.
Diagnosis of comorbid ESRD or comorbid severe CKD prior to the index date.
Participant has undergone solid organ transplant (SOT) or hematopoietic stem cell transplantation (HSCT) before index date.
Participant was diagnosed with refractory (with or without resistance) CMV during the latest post-transplant period.
Participant initiated treatment with maribavir in routine practice within the eligibility period and received at least 1 dose of maribavir.
Informed consent provided (where required by local regulations) before data collection commences.
Exclusion Criteria:
There are no exclusion criteria for this study.
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Participants treated with maribavir for a refractory (with or without resistance) CMV infection and who have severe CKD or comorbid ESRD including participants on peritoneal dialysis or hemodialysis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Takeda Contact | Contact | +1-877-825-3327 | medinfoUS@takeda.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Erasme - PPDS | Not yet recruiting | Anderlecht | Brussels Capital | 1070 | Belgium |
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| Label | URL |
|---|---|
| Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed. | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| Time from index treatment date until 7 days after the date of the end of supply of the last prescription of treatment or date of death, whichever occurs first (up to 4 years) |
| UZ Leuven - PPDS | Not yet recruiting | Leuven | Vlaams Brabant | 3000 | Belgium |
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| North Estonia Medical Centre Foundation | Recruiting | Tallinn | Harju | 13419 | Estonia |
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| Tartu University Hospital | Recruiting | Tartu | 60535 | Estonia |
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| CHU de Brest - Hopital La Cavale Blanche | Recruiting | Brest | Finistere | 29200 | France |
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| CHU de Bordeaux - Hopital Pellegrin | Recruiting | Bordeaux | Gironde | 33000 | France |
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| CHU de Montpellier - Hopital Lapeyronie | Recruiting | Montpellier | Herault | 34090 | France |
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| CHU de Grenoble Alpes - Hopital Michallon | Recruiting | La Tronche | Isere | 38700 | France |
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| AP-HP - Hopital Henri Mondor | Recruiting | Créteil | Val-de-Marne | 94000 | France |
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| Universitatsklinikum Wurzburg | Not yet recruiting | Würzburg | Bavaria | 97080 | Germany |
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| Universitatsklinikum Leipzig | Not yet recruiting | Leipzig | Saxony | 4103 | Germany |
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| Azienda Ospedaliera Dei Colli - Ospedale Monaldi | Not yet recruiting | Naples | 80131 | Italy |
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| Fondazione IRCCS Policlinico San Matteo | Not yet recruiting | Pavia | 27100 | Italy |
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| Hospital Universitario de Bellvitge | Not yet recruiting | L'Hospitalet de Llobregat | Barcelona | 8907 | Spain |
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| Hospital Universitario Cruces | Not yet recruiting | Barakaldo | Vizcaya | 48903 | Spain |
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| Hospital Universitario Vall d'Hebron - PPDS | Recruiting | Barcelona | 8035 | Spain |
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| Hospital Clinic de Barcelona | Not yet recruiting | Barcelona | 8036 | Spain |
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| C.H. Regional Reina Sofia - PPDS | Not yet recruiting | Córdoba | 14004 | Spain |
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| Hospital Universitario Ramon y Cajal | Not yet recruiting | Madrid | 28304 | Spain |
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| Hospital Regional Universitario de Malaga Hospital General | Recruiting | Málaga | 29010 | Spain |
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| Hospital Universitario Virgen del Rocio - PPDS | Not yet recruiting | Seville | 41013 | Spain |
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| Dorset County Hospital | Not yet recruiting | Dorchester | Dorset | DT1 2JY | United Kingdom |
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| Queen Elizabeth Hospital Birmingham | Not yet recruiting | Birmingham | B15 2GW | United Kingdom |
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| King's College Hospital | Not yet recruiting | London | SE5 9RS | United Kingdom |
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| Wrexham Maelor Hospital | Not yet recruiting | Wrexham | LL13 7TD | United Kingdom |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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