Investigation of Refractory CMV (Cytomegalovirus) Infection or Disease, After Kidney Transplantation, Using UK (United Kingdom) National Registry of Rare Kidney Diseases (RaDaR)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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 this study are the following: * 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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).

Locations
Other Locations
United Kingdom
RaDaR (part of the UK Kidney Association)
RECRUITING
Bristol
Contact Information
Primary
Takeda Contact
medinfoemea@takeda.com
+44 (0)3333 000181
Time Frame
Start Date: 2024-09-30
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 672
Treatments
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).
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).
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov