A Study of Cytomegalovirus (CMV) Infection After Kidney Transplant in Adults in the United Kingdom
NCT ID: NCT06568055
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
672 participants
OBSERVATIONAL
2024-09-30
2025-12-31
Brief Summary
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* To estimate the overall prevalence and annual rate of adults with refractory CMV infection after a kidney transplant and describe how such CMV infections are treated
* To describe how effective and well-tolerated the treatment was.
* To describe the demographic and clinical characteristics of adult participants with CMV infection (refractory and non-refractory).
In this study, already existing data will be reviewed and analysed from a UK database called the Registry of Rare Kidney Diseases (RaDaR) (NCT06065852). The study will only review data collected as part of routine clinical practice. The study will not impact the standard medical care and treatment of participants.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Refractory CMV group
Participants who had a kidney transplantation (including re-transplantation) with refractory CMV infection will be identified from five solid organ transplantation centres in England and followed retrospectively for at least 6 months and up to 7 years until the end of 2024 or exit date from the cohort for any reasons, including death or end of participation in the registry (follow up period).
No Intervention
This is non-interventional study.
Reference cohort of non-refractory CMV group
Participants with non-refractory CMV infection who have responded to initial anti-CMV therapy post-transplant with no CMV refractory to treatment will be followed retrospectively for at least 6 months and up to 7 years until the end of 2024 or exit date from the cohort for any reasons, including death or end of participation in the registry (follow up period).
No Intervention
This is non-interventional study.
Interventions
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No Intervention
This is non-interventional study.
Eligibility Criteria
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Inclusion Criteria
1. Participants aged greater than or equal to (\>=) 18 years at index date
2. Kidney transplant recipients on or subsequent to June 2016.
3. CMV viraemia or disease identified as requiring treatment and which was refractory to previous CMV management (at least one course of therapy), with or without confirmed resistance.
4. At least six months follow up time (except for participants who have died earlier).
Reference cohort of non-refractory CMV group:
1. Participants aged \>=18 years.
2. Kidney transplant recipients.
3. Received initial CMV management (at least one course of therapy).
4. At least six months follow up time (except for participants who have died earlier).
Exclusion Criteria
1. Multi-organ transplant recipients.
2. Participation recorded in an anti-CMV prophylaxis or treatment clinical trial from 2010 onward.
Participants with non-refractory CMV are to be included as a reference to indicate impact of refractory CMV not responding to initial therapy on resource use and other outcomes.
Reference cohort of non-refractory CMV group:
1. Multi-organ transplant recipients.
2. Participation recorded in an anti-CMV prophylaxis or treatment clinical trial from 2010.
3. CMV viremia or disease refractory to any previous anti-CMV therapy.
4. Treatment for CMV viremia or disease refractory to initial therapy during the follow up period.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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RaDaR (part of the UK Kidney Association)
Bristol, Southwestern England, United Kingdom
Countries
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Related Links
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Click here for more information about this trial in easy-to-understand language.
Other Identifiers
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TAK-620-4012
Identifier Type: -
Identifier Source: org_study_id