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Completed

NCT Number: NCT06568055

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

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.

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Key information

Conditions

Cytomegalovirus (CMV)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

RaDaR (part of the UK Kidney Association)

Bristol, Southwestern England, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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.

Treatment and study plan

No intervention

Other

This is non-interventional study.

Primary outcomes

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

    Time frame: 1 year

  2. Number of New Non-Refractory and Refractory CMV Cases per Year

    Time frame: 7 years

  3. Percentage of Participants Given Prophylaxis at the Time of Kidney Transplant

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

  4. Distribution of Drugs Prescribed for Prophylaxis

    Time frame: Up to 7 years

  5. Duration of Prophylactic Treatment

    Time frame: Up to 7 years

  6. Dose of Prophylactic Treatment

    Time frame: Up to 7 years

  7. Distribution of Drugs Prescribed for Initial Anti-CMV Treatment

    Time frame: Up to 7 years

  8. Duration of Initial Anti-CMV Treatment

    Time frame: Up to 7 years

  9. Dose of Initial Anti-CMV Treatment

    Time frame: Up to 7 years

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

    Time frame: Up to 7 years

    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.

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

    Time frame: Up to 7 years

  12. Dose of Anti-CMV Treatment Subsequent to Initial Anti-CMV Therapy

    Time frame: Up to 7 years

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

    Time frame: 6 months follow up period from index date

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

    Time frame: Up to 7 years

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

    Time frame: 6 months 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.

  16. Number of Participants as per Positioning of Marabivir in the Treatment Pathway

    Time frame: Up to 7 years

    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.

  17. Percentage of Participants With Viral Clearance During the Follow up Period

    Time frame: 6 months follow up period

    Viral clearance is defined as CMV concentration below detectable level.

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

    Time frame: Up to 7 years

  19. Percentage of Participants With Recurrence of CMV Infection

    Time frame: Up to 7 years

  20. Number of Hospital Admissions (per Year and Overall)

    Time frame: Up to 7 years

  21. Reasons for Hospital Admission

    Time frame: Up to 7 years

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

    Time frame: 6 months of follow up period

  23. Duration of Hospitalisation

    Time frame: Up to 7 years

  24. Number of Outpatient Visits in Six-month Follow up Period

    Time frame: 6 months of follow up period

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

    Time frame: 6 months of follow up period from index date

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

    Time frame: Up to 7 years

    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).

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

    Time frame: Up to 7 years

  28. Number of Participants Who Died

    Time frame: Up to 7 years

  29. Time to Death From Index Date/Transplant Date

    Time frame: From Index date/transplant date up to 7 years

    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.

  30. Number of Mortality (All-cause Death)

    Time frame: Up to 7 years

  31. Number of Participants With Reasons for Mortality

    Time frame: Up to 7 years

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

    Time frame: From index date to 6 months of 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.

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

    Time frame: From index date to 6 months of 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.

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

    Time frame: At the time of transplant (up to 7 years)

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 23, 2024
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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