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A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation

Sponsor: Takeda

NCT ID: NCT06243731

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
No Intervention (other)
How long the study runs
Study runs about 14 months (dates as stated)
About the drug or intervention
No Intervention — other: This is a non-interventional study.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at adults with kidney failure or severe long-term kidney disease who developed a cytomegalovirus (CMV) infection after having an organ or stem cell transplant. CMV is a common virus that can cause problems in people whose immune systems are weak. The study follows people who were already given a medicine called maribavir as part of their normal care because their CMV infection did not get better with earlier treatment.

Who can take part

  • Adults aged 18 or over
  • Diagnosed with kidney failure (end-stage renal disease) or severe long-term kidney disease before the study period
  • If kidney failure: confirmed by a kidney filter rate (eGFR) under 15 mL/min/1.73m², including people on dialysis
  • If severe long-term kidney disease: confirmed by a kidney filter rate (eGFR) of 15 to under 30 mL/min/1.73m²
  • Had a solid organ transplant or a blood stem cell transplant before the study period
  • Diagnosed with a CMV infection after transplant that did not respond to earlier treatment (with or without resistance)
  • Started treatment with maribavir as part of normal care during the study period and received at least one dose
  • Gave informed consent where local rules require it, before any data was collected

Who may not be able to

  • Not stated — ask your trial team (the study lists no reasons that would exclude someone)

What taking part involves

  • • Taking maribavir, a medicine for CMV, as prescribed in normal practice (at least one dose)

Time commitment: Not stated — ask the trial team what taking part involves, including any visits and how long the study lasts.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
10
Started
2025-11-03
Last checked
2025-12

Plain English Summary

What is this study?

  • • Testing a new treatment for cytomegalovirus (cmv)
  • • Clinical study - 10 participants
  • • The main aim of this study is to assess the safety of maribavir in adults with severe CKD or comorbid ESRD including participants on artificial filtering of the kidney (dialysis) or the blood (hemodialysis)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with cytomegalovirus (cmv)

Where?

  • • Dorchester - Dorset County Hospital
  • • Birmingham - Queen Elizabeth Hospital Birmingham
  • • London - King's College Hospital
  • • Wrexham - Wrexham Maelor Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The main aim of this study is to assess the safety of maribavir in adults with severe CKD or comorbid ESRD including participants on artificial filtering of the kidney (dialysis) or the blood (hemodialysis). In this study, already existing data will be collected from the participant's medical records. The study will only review data collected as part of the normal clinical routine and will not impact the standard medical care and treatment of participants.

Cytomegalovirus (CMV)Kidney DiseaseKidney Failure

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFR

Treatment history

Treatments you must have had:

  • ✓ by local regulations)

What the study is looking for

  • ✓Adults more than and equal to (≥) 18 years of age at index date.
  • ✓Diagnosis of comorbid ESRD or comorbid severe CKD prior to the index date.
  • ✓If severe CKD: participant diagnosed with severe CKD confirmed by an eGFR of 15 to \<30 mL/min/1.73m\^2 at index.
  • ✓Participant has undergone solid organ transplant (SOT) or hematopoietic stem cell transplantation (HSCT) before...
  • ✓Participant was diagnosed with refractory (with or without resistance) CMV during the latest post-transplant period.

Who cannot take part

  • ✗There are no exclusion criteria for this study.
See the full criteria
Inclusion Criteria: * Adults more than and equal to (≥) 18 years of age at index date. * Diagnosis of comorbid ESRD or comorbid severe CKD prior to the index date. * If ESRD (including participants on peritoneal dialysis or hemodialysis): participant diagnosed with ESRD confirmed by an estimated glomerular filtration rate (eGFR) less than (\<) 15 milliliters per minute per 1.73 square meters (mL/min/1.73m\^2). * If severe CKD: participant diagnosed with severe CKD confirmed by an eGFR of 15 to \<30 mL/min/1.73m\^2 at index. * Participant has undergone solid organ transplant (SOT) or hematopoietic stem cell transplantation (HSCT) before index date. * Participant was diagnosed with refractory (with or without resistance) CMV during the latest post-transplant period. * Participant initiated treatment with maribavir in routine practice within the eligibility period and received at least 1 dose of maribavir. * Informed consent provided (where required by local regulations) before data collection commences. Exclusion Criteria: There are no exclusion criteria for this study.

Where Is This Study? (4 UK sites)

Dorset County Hospital

Dorchester DT1 2JY, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Joanne TaylorPrincipal Investigator

Queen Elizabeth Hospital Birmingham

Birmingham B15 2GW, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Bhuvan KishorePrincipal Investigator

King's College Hospital

London SE5 9RS, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Sapna ShahPrincipal Investigator

Wrexham Maelor Hospital

Wrexham LL13 7TD, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Stuart RobertsonPrincipal Investigator

How to Get in Touch

Takeda Contact

Sponsor contact

CONTACT

+1-877-825-3327 medinfoUS@takeda.com
Data sourced from ClinicalTrials.gov · Last verified: 2025-12