Cytomegalovirus (CMV)NCT06568055
A Study of Cytomegalovirus (CMV) Infection After Kidney Transplant in Adults in the United Kingdom
An observational study of Cytomegalovirus (CMV), run by Takeda at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus (CMV)
- How many people
- 330 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Sep 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Refractory CMV group:
- Participants aged greater than or equal to (>=) 18 years at index date
- Kidney transplant recipients on or subsequent to June 2016.
- 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:
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- 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).
Who cannot join
- 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.
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- Participation recorded in an anti-CMV prophylaxis or treatment clinical trial from 2010.
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
RaDaR (part of the UK Kidney Association)
Bristol, Southwestern England
About this study
Official title: Investigation of Refractory CMV (Cytomegalovirus) Infection or Disease, After Kidney Transplantation, Using UK (United Kingdom) National Registry of Rare Kidney Diseases (RaDaR)
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.
- Conditions
- Cytomegalovirus (CMV)
- Being tested
- No Intervention
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: No Intervention | |
| 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). Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Non-Refractory and Refractory CMV Post-Kidney Transplant in 2024
Measured: 1 year
Number of New Non-Refractory and Refractory CMV Cases per Year
Measured: 7 years
Percentage of Participants Given Prophylaxis at the Time of Kidney Transplant
Measured: At the time of kidney transplant (up to 7 years)
Distribution of Drugs Prescribed for Prophylaxis
Measured: Up to 7 years
Duration of Prophylactic Treatment
Measured: Up to 7 years
Dose of Prophylactic Treatment
Measured: Up to 7 years
Distribution of Drugs Prescribed for Initial Anti-CMV Treatment
Measured: Up to 7 years
Duration of Initial Anti-CMV Treatment
Measured: Up to 7 years
Dose of Initial Anti-CMV Treatment
Measured: 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.
Measured: Up to 7 years
Duration of Time on Anti-CMV Treatment Subsequent to Initial Anti-CMV Therapy
Measured: Up to 7 years
Dose of Anti-CMV Treatment Subsequent to Initial Anti-CMV Therapy
Measured: 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
Measured: 6 months follow up period from index date
Time to Switch of Drug for Anti-CMV Treatment Subsequent to Initial Therapy
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months follow up period
Time to Viremia Recurrence From Documented Clearance or Cessation of Anti-CMV Treatment
Measured: Up to 7 years
Percentage of Participants With Recurrence of CMV Infection
Measured: Up to 7 years
Number of Hospital Admissions (per Year and Overall)
Measured: Up to 7 years
Reasons for Hospital Admission
Measured: Up to 7 years
Number of Hospitalisations (Including Intensive Care) per Participant in Six-Month Follow up Period
Measured: 6 months of follow up period
Duration of Hospitalisation
Measured: Up to 7 years
Number of Outpatient Visits in Six-month Follow up Period
Measured: 6 months of follow up period
Percentage of Participants With Graft Loss in Six-month Follow up Period
Measured: 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).
Measured: Up to 7 years
Percentage of Participants With Graft Loss Over Time for Refractory Versus non-Refractory Group
Measured: Up to 7 years
Number of Participants Who Died
Measured: 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.
Measured: From Index date/transplant date up to 7 years
Number of Mortality (All-cause Death)
Measured: Up to 7 years
Number of Participants With Reasons for Mortality
Measured: 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.
Measured: 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.
Measured: From index date to 6 months of follow up period
Percentage of Participants with Diabetes, Hypertension, and Cardiovascular Disease at the Time of Transplant
Measured: At the time of transplant (up to 7 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start30 Sep 2024
- Primary completion31 Oct 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus (CMV)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568055
- Sponsor's protocol ID
- TAK-620-4012
- Status last verified
- Jan 2026
- First submitted
- 9 Aug 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Refractory CMV (Cytomegalovirus) Infection or Disease, After Kidney Transplantation, Using UK (United Kingdom) National Registry of Rare Kidney Diseases (RaDaR)
- ClinicalTrials.gov ID
- NCT06568055
- Acronym / sponsor ID
- TAK-620-4012
- Conditions
- Cytomegalovirus (CMV)
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Refractory CMV group | – | Other: No InterventionParticipants 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 | – | Other: No InterventionParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- Participants aged greater than or equal to (>=) 18 years at index date
- Kidney transplant recipients on or subsequent to June 2016.
- 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).
- Participants aged >=18 years.
Key exclusion criteria (9 listed)
- 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.
- Multi-organ transplant recipients.
- Participation recorded in an anti-CMV prophylaxis or treatment clinical trial from 2010.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is non-interventional study. | Other | Reference cohort of non-refractory CMV group, Refractory CMV group |
Primary outcome
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
Time frame: 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
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
Time frame: 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
Time frame: 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
Time frame: 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
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
Time frame: 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
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
Time frame: 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)
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
Time frame: 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
Time frame: 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
Time frame: At the time of transplant (up to 7 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Click here for more information about this trial in easy-to-understand language.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus (CMV), run by Takeda at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Non-Refractory and Refractory CMV Post-Kidney Transplant in 2024 (time frame: 1 year). The study lists 34 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.