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

Last updated: December 23, 2024
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cytomegalovirus Infections

Treatment

No Intervention

Clinical Study ID

NCT06568055
TAK-620-4012
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 refractoryto previous CMV management (at least one course of therapy), with or withoutconfirmed 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

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

  4. CMV viremia or disease refractory to any previous anti-CMV therapy.

  5. Treatment for CMV viremia or disease refractory to initial therapy during the followup period.

Study Design

Total Participants: 672
Treatment Group(s): 1
Primary Treatment: No Intervention
Phase:
Study Start date:
September 30, 2024
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • RaDaR (part of the UK Kidney Association)

    Bristol, Southwestern England
    United Kingdom

    Active - Recruiting

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