Status:
ACTIVE_NOT_RECRUITING
A Study of Cytomegalovirus (CMV) Infection After Kidney Transplant in Adults in the United Kingdom
Lead Sponsor:
Takeda
Conditions:
Cytomegalovirus (CMV)
Eligibility:
All Genders
18+ years
Brief Summary
This observational study intends to retrospectively gather information on cytomegalovirus (CMV) infection management in the United Kingdom (UK) over a period of 7 years (2017-2024). The main aims of t...
Eligibility Criteria
Inclusion
- Refractory CMV group:
- Participants aged greater than or equal to (\>=) 18 years at index date
- Kidney transplant recipients on or subsequent to June 2016.
- 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.
- At least six months follow up time (except for participants who have died earlier).
- Reference cohort of non-refractory CMV group:
- Participants aged \>=18 years.
- Kidney transplant recipients.
- Received initial CMV management (at least one course of therapy).
- At least six months follow up time (except for participants who have died earlier).
Exclusion
- Refractory CMV group:
- Multi-organ transplant recipients.
- 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:
- Multi-organ transplant recipients.
- Participation recorded in an anti-CMV prophylaxis or treatment clinical trial from 2010.
- CMV viremia or disease refractory to any previous anti-CMV therapy.
- Treatment for CMV viremia or disease refractory to initial therapy during the follow up period.
Key Trial Info
Start Date :
September 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
672 Patients enrolled
Trial Details
Trial ID
NCT06568055
Start Date
September 30 2024
End Date
December 31 2025
Last Update
December 26 2025
Active Locations (1)
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1
RaDaR (part of the UK Kidney Association)
Bristol, Southwestern England, United Kingdom