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.
Study Type
OBSERVATIONAL
Enrollment
330
This is non-interventional study.
RaDaR (part of the UK Kidney Association)
Bristol, Southwestern England, United Kingdom
Number of Participants With Non-Refractory and Refractory CMV Post-Kidney Transplant in 2024
Time frame: 1 year
Number of New Non-Refractory and Refractory CMV Cases per Year
Time frame: 7 years
Percentage of Participants Given Prophylaxis at the Time of Kidney Transplant
Time frame: At the time of kidney transplant (up to 7 years)
Distribution of Drugs Prescribed for Prophylaxis
Time frame: Up to 7 years
Duration of Prophylactic Treatment
Time frame: Up to 7 years
Dose of Prophylactic Treatment
Time frame: Up to 7 years
Distribution of Drugs Prescribed for Initial Anti-CMV Treatment
Time frame: Up to 7 years
Duration of Initial Anti-CMV Treatment
Time frame: Up to 7 years
Dose of Initial Anti-CMV Treatment
Time frame: 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.
Time frame: Up to 7 years
Duration of Time on Anti-CMV Treatment Subsequent to Initial Anti-CMV Therapy
Time frame: Up to 7 years
Dose of Anti-CMV Treatment Subsequent to Initial Anti-CMV Therapy
Time frame: 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
Time frame: 6 months follow up period from index date
Time to Switch of Drug for Anti-CMV Treatment Subsequent to Initial Therapy
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months follow up period
Time to Viremia Recurrence From Documented Clearance or Cessation of Anti-CMV Treatment
Time frame: Up to 7 years
Percentage of Participants With Recurrence of CMV Infection
Time frame: Up to 7 years
Number of Hospital Admissions (per Year and Overall)
Time frame: Up to 7 years
Reasons for Hospital Admission
Time frame: Up to 7 years
Number of Hospitalisations (Including Intensive Care) per Participant in Six-Month Follow up Period
Time frame: 6 months of follow up period
Duration of Hospitalisation
Time frame: Up to 7 years
Number of Outpatient Visits in Six-month Follow up Period
Time frame: 6 months of follow up period
Percentage of Participants With Graft Loss in Six-month Follow up Period
Time frame: 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).
Time frame: Up to 7 years
Percentage of Participants With Graft Loss Over Time for Refractory Versus non-Refractory Group
Time frame: Up to 7 years
Number of Participants Who Died
Time frame: 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.
Time frame: From Index date/transplant date up to 7 years
Number of Mortality (All-cause Death)
Time frame: Up to 7 years
Number of Participants With Reasons for Mortality
Time frame: 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.
Time frame: 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.
Time frame: From index date to 6 months of follow up period
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)
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