Investigation of Refractory CMV (Cytomegalovirus) Infection or Disease, After Kidney Transplantation, Using UK (United Kingdom) National Registry of Rare Kidney Diseases (RaDaR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Number of Participants With Non-Refractory and Refractory CMV Post-Kidney Transplant in 2024
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Refractory CMV group:
- •Participants aged greater than or equal to (>=) 18 years at index date
- •Kidney transplant recipients on or subsequent to June
- •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).
排除标准
- •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
- •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.
研究组 & 干预措施
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).
干预措施: No Intervention (Other)
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).
干预措施: No Intervention (Other)
结局指标
主要结局
Number of Participants With Non-Refractory and Refractory CMV Post-Kidney Transplant in 2024
时间窗: 1 year
Duration of Initial Anti-CMV Treatment
时间窗: Up to 7 years
Number of New Non-Refractory and Refractory CMV Cases per Year
时间窗: 7 years
Number of Outpatient Visits in Six-month Follow up Period
时间窗: 6 months of follow up period
Percentage of Participants With Graft Loss in Six-month Follow up Period
时间窗: 6 months of follow up period from index date
Percentage of Participants Given Prophylaxis at the Time of Kidney Transplant
时间窗: At the time of kidney transplant (up to 7 years)
Distribution of Drugs Prescribed for Prophylaxis
时间窗: Up to 7 years
Dose of Initial Anti-CMV Treatment
时间窗: Up to 7 years
Distribution of Drugs Prescribed as Anti-CMV Treatment Subsequent to Initial Therapy in Participants With Refractory CMV
时间窗: 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
时间窗: Up to 7 years
Dose of Anti-CMV Treatment Subsequent to Initial Anti-CMV Therapy
时间窗: 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
时间窗: 6 months follow up period from index date
Time to Switch of Drug for Anti-CMV Treatment Subsequent to Initial Therapy
时间窗: Up to 7 years
Duration of Prophylactic Treatment
时间窗: Up to 7 years
Dose of Prophylactic Treatment
时间窗: Up to 7 years
Distribution of Drugs Prescribed for Initial Anti-CMV Treatment
时间窗: Up to 7 years
Number of Switches per Participants in Six-Month Follow up Period
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Up to 7 years
Percentage of Participants With Recurrence of CMV Infection
时间窗: Up to 7 years
Number of Hospital Admissions (per Year and Overall)
时间窗: Up to 7 years
Reasons for Hospital Admission
时间窗: Up to 7 years
Number of Hospitalisations (Including Intensive Care) per Participant in Six-Month Follow up Period
时间窗: 6 months of follow up period
Duration of Hospitalisation
时间窗: Up to 7 years
Number of Occurrences of Each Reason for Graft Loss Listed in the Registry
时间窗: 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).
Number of Participants With Reasons for Mortality
时间窗: Up to 7 years
Percentage of Participants With Graft Loss Over Time for Refractory Versus non-Refractory Group
时间窗: Up to 7 years
Number of Mortality (All-cause Death)
时间窗: Up to 7 years
Number of Participants Who Died
时间窗: Up to 7 years
Time to Death From Index Date/Transplant Date
时间窗: 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.
Change in Renal Function (Estimated Glomerular Filtration Rate [eGFR]) From Index Date to Six-month Follow up
时间窗: 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
时间窗: 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
时间窗: At the time of transplant (up to 7 years)
次要结局
未报告次要终点