Cytomegalovirus (CMV)
Conditions
Keywords
Drug Therapy
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.
Interventions
OTHERNo Intervention
This is non-interventional study.
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 refractory to previous CMV management (at least one course of therapy), with or without confirmed 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 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 2010. 3. CMV viremia or disease refractory to any previous anti-CMV therapy. 4. Treatment for CMV viremia or disease refractory to initial therapy during the follow up period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| Number of Participants as per Positioning of Marabivir in the Treatment Pathway | 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. |
| Percentage of Participants With Viral Clearance During the Follow up Period | 6 months follow up period | Viral clearance is defined as CMV concentration below detectable level. |
| 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 | 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). |
| 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 | 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. |
| 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 | 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. |
| Change in White Cell Count (Neutrophils) From Index Date to Six-month Follow up | 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. |
| Percentage of Participants with Diabetes, Hypertension, and Cardiovascular Disease at the Time of Transplant | At the time of transplant (up to 7 years) | — |
Countries
United Kingdom
Contacts
STUDY_DIRECTORStudy Director
Takeda
Outcome results
None listed