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

NCT06568055 | Completed

• 1 other identifier: TAK-620-4012
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cytomegalovirus (CMV)

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (34)

• Number of Participants With Non-Refractory and Refractory CMV Post-Kidney Transplant in 2024

  1 year

• Number of New Non-Refractory and Refractory CMV Cases per Year

  7 years

• Percentage of Participants Given Prophylaxis at the Time of Kidney Transplant

  At the time of kidney transplant (up to 7 years)

• Distribution of Drugs Prescribed for Prophylaxis

  Up to 7 years

• Duration of Prophylactic Treatment

  Up to 7 years

• Dose of Prophylactic Treatment

  Up to 7 years

• Distribution of Drugs Prescribed for Initial Anti-CMV Treatment

  Up to 7 years

• Duration of Initial Anti-CMV Treatment

  Up to 7 years

• Dose of Initial Anti-CMV Treatment

  Up to 7 years

• Distribution of Drugs Prescribed as Anti-CMV Treatment Subsequent to Initial Therapy in Participants With Refractory CMV

  Distribution of drugs prescribed as anti-CMV treatment subsequent to initial therapy (that is, valganciclovir, ganciclovir, foscarnet, cidofovir, cytotect, maribavir) in participants with refractory CMV will be reported.

  Up to 7 years

• Duration of Time on Anti-CMV Treatment Subsequent to Initial Anti-CMV Therapy

  Up to 7 years

• Dose of Anti-CMV Treatment Subsequent to Initial Anti-CMV Therapy

  Up to 7 years

• Percentage of Participants With Refractory CMV Who Switched Type of Anti-CMV Treatment Subsequent to Initial Therapy in Six-Month Follow up Period

  6 months follow up period from index date

• Time to Switch of Drug for Anti-CMV Treatment Subsequent to Initial Therapy

  Up to 7 years

• Number of Switches per Participants in Six-Month Follow up Period

  The index date for all participants will be the earliest date between 1st January 2017 and 30th June 2024 when initial treatment for CMV was initiated.

  6 months follow up period

• Number of Participants as per Positioning of Marabivir in the Treatment Pathway

  Number of participants as per positioning of marabivir in the treatment pathway with first, second or third line of anti-CMV treatment subsequent to initial therapy will be reported.

  Up to 7 years

• Percentage of Participants With Viral Clearance During the Follow up Period

  Viral clearance is defined as CMV concentration below detectable level.

  6 months follow up period

• Time to Viremia Recurrence From Documented Clearance or Cessation of Anti-CMV Treatment

  Up to 7 years

• Percentage of Participants With Recurrence of CMV Infection

  Up to 7 years

• Number of Hospital Admissions (per Year and Overall)

  Up to 7 years

• Reasons for Hospital Admission

  Up to 7 years

• Number of Hospitalisations (Including Intensive Care) per Participant in Six-Month Follow up Period

  6 months of follow up period

• Duration of Hospitalisation

  Up to 7 years

• Number of Outpatient Visits in Six-month Follow up Period

  6 months of follow up period

• Percentage of Participants With Graft Loss in Six-month Follow up Period

  6 months of follow up period from index date

• Number of Occurrences of Each Reason for Graft Loss Listed in the Registry

  Graft loss being defined as re-establishment of long-term dialysis or estimated glomerular filtration rate (eGFR) of less than (\<) 15 milliliter per minute (mL/min).

  Up to 7 years

• Percentage of Participants With Graft Loss Over Time for Refractory Versus non-Refractory Group

  Up to 7 years

• Number of Participants Who Died

  Up to 7 years

• Time to Death From Index Date/Transplant Date

  The index date for all participants will be the earliest date between 1st January 2017 and 30th June 2024 when initial treatment for CMV was initiated.

  From Index date/transplant date up to 7 years

• Number of Mortality (All-cause Death)

  Up to 7 years

• Number of Participants With Reasons for Mortality

  Up to 7 years

• Change in Renal Function (Estimated Glomerular Filtration Rate [eGFR]) From Index Date to Six-month Follow up

  The index date for all participants will be the earliest date between 1st January 2017 and 30th June 2024 when initial treatment for CMV was initiated.

  From index date to 6 months of follow up period

• Change in White Cell Count (Neutrophils) From Index Date to Six-month Follow up

  The index date for all participants will be the earliest date between 1st January 2017 and 30th June 2024 when initial treatment for CMV was initiated.

  From index date to 6 months of follow up period

• Percentage of Participants with Diabetes, Hypertension, and Cardiovascular Disease at the Time of Transplant

  At the time of transplant (up to 7 years)

Study Arms (2)

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).

Other: No Intervention

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).

Other: No Intervention

Interventions

No Intervention OTHER

This is non-interventional study.

Reference cohort of non-refractory CMV group; Refractory CMV group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with refractory CMV infection post-kidney transplant will be included. The reference cohort will include all participants identified to have responded to initial anti-CMV therapy post-transplant with no CMV which required the treatment of a 2nd anti-CMV agent during this episode of infection.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

RaDaR (part of the UK Kidney Association)

Bristol, Southwestern England, United Kingdom

Location

Related Links

• Click here for more information about this trial in easy-to-understand language.

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 23, 2024
• Study Start: September 30, 2024
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)