A Study of Cytomegalovirus (CMV) Infection After Kidney Transplant in Adults in the United Kingdom

Takeda

Status: Completed

Conditions: Cytomegalovirus (CMV)

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06568055

TAK-620-4012

Details and patient eligibility

About

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.

Enrollment: 330 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Refractory CMV group:

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

Refractory CMV group:

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.

Trial design

330 participants in 2 patient groups

Refractory CMV group

Description:

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).

Treatment:

Other: No Intervention

Reference cohort of non-refractory CMV group

Description:

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).

Treatment:

Other: No Intervention