Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | This is non-interventional study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Not provided
Inclusion Criteria:
Refractory CMV group:
Reference cohort of non-refractory CMV group:
Exclusion Criteria:
Refractory CMV group:
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:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RaDaR (part of the UK Kidney Association) | Bristol | Southwestern England | United Kingdom |
Not provided
| Label | URL |
|---|---|
| Click here for more information about this trial in easy-to-understand language. | View source |
Not provided
De-identified individual participant data from this particular study will not be shared as the data are subject to contractual (or consent) provisions that prohibit transfer to third parties.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) |