Clinical trial NCT06568055: A Study of Cytomegalovirus (CMV) Infection After Kidney Transplant in Adults in the United Kingdom
Official title: Investigation of Refractory CMV (Cytomegalovirus) Infection or Disease, After Kidney Transplantation, Using UK (United Kingdom) National Registry of Rare Kidney Diseases (RaDaR)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cytomegalovirus (CMV)
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-08-23
Enrollment: 672
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Non-Refractory and Refractory CMV Post-Kidney Transplant in 2024
timeFrame: 1 year
measure: Number of New Non-Refractory and Refractory CMV Cases per Year
timeFrame: 7 years
measure: Percentage of Participants Given Prophylaxis at the Time of Kidney Transplant
timeFrame: At the time of kidney transplant (up to 7 years)
measure: Distribution of Drugs Prescribed for Prophylaxis
timeFrame: Up to 7 years
measure: Duration of Prophylactic Treatment
timeFrame: Up to 7 years
measure: Dose of Prophylactic Treatment
timeFrame: Up to 7 years
measure: Distribution of Drugs Prescribed for Initial Anti-CMV Treatment
timeFrame: Up to 7 years
measure: Duration of Initial Anti-CMV Treatment
timeFrame: Up to 7 years
measure: Dose of Initial Anti-CMV Treatment
timeFrame: Up to 7 years
measure: Distribution of Drugs Prescribed as Anti-CMV Treatment Subsequent to Initial Therapy in Participants With Refractory CMV
timeFrame: Up to 7 years
measure: Duration of Time on Anti-CMV Treatment Subsequent to Initial Anti-CMV Therapy
timeFrame: Up to 7 years
measure: Dose of Anti-CMV Treatment Subsequent to Initial Anti-CMV Therapy
timeFrame: Up to 7 years
measure: Percentage of Participants With Refractory CMV Who Switched Type of Anti-CMV Treatment Subsequent to Initial Therapy in Six-Month Follow up Period
timeFrame: 6 months follow up period from index date
measure: Time to Switch of Drug for Anti-CMV Treatment Subsequent to Initial Therapy
timeFrame: Up to 7 years
measure: Number of Switches per Participants in Six-Month Follow up Period
timeFrame: 6 months follow up period
measure: Number of Participants as per Positioning of Marabivir in the Treatment Pathway
timeFrame: Up to 7 years
measure: Percentage of Participants With Viral Clearance During the Follow up Period
timeFrame: 6 months follow up period
measure: Time to Viremia Recurrence From Documented Clearance or Cessation of Anti-CMV Treatment
timeFrame: Up to 7 years
measure: Percentage of Participants With Recurrence of CMV Infection
timeFrame: Up to 7 years
measure: Number of Hospital Admissions (per Year and Overall)
timeFrame: Up to 7 years
measure: Reasons for Hospital Admission
timeFrame: Up to 7 years
measure: Number of Hospitalisations (Including Intensive Care) per Participant in Six-Month Follow up Period
timeFrame: 6 months of follow up period
measure: Duration of Hospitalisation
timeFrame: Up to 7 years
measure: Number of Outpatient Visits in Six-month Follow up Period
timeFrame: 6 months of follow up period
measure: Percentage of Participants With Graft Loss in Six-month Follow up Period
timeFrame: 6 months of follow up period from index date
measure: Number of Occurrences of Each Reason for Graft Loss Listed in the Registry
timeFrame: Up to 7 years
measure: Percentage of Participants With Graft Loss Over Time for Refractory Versus non-Refractory Group
timeFrame: Up to 7 years
measure: Number of Participants Who Died
timeFrame: Up to 7 years
measure: Time to Death From Index Date/Transplant Date
timeFrame: From Index date/transplant date up to 7 years
measure: Number of Mortality (All-cause Death)
timeFrame: Up to 7 years
measure: Number of Participants With Reasons for Mortality
timeFrame: Up to 7 years
measure: Change in Renal Function (Estimated Glomerular Filtration Rate [eGFR]) From Index Date to Six-month Follow up
timeFrame: From index date to 6 months of follow up period
measure: Change in White Cell Count (Neutrophils) From Index Date to Six-month Follow up
timeFrame: From index date to 6 months of follow up period
measure: Percentage of Participants with Diabetes, Hypertension, and Cardiovascular Disease at the Time of Transplant
timeFrame: At the time of transplant (up to 7 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: RaDaR (part of the UK Kidney Association)
state: Southwestern England
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: