Observational study on CMV infection after kidney transplant in adults in the UK

Investigation of Refractory CMV (Cytomegalovirus) Infection or Disease, After Kidney Transplantation, Using UK (United Kingdom) National Registry of Rare Kidney Diseases (RaDaR)

This study looks at how common and manageable cytomegalovirus infections are in adults who had kidney transplants in the UK over the past seven years.

Quick facts

• Study type: Observational
• Enrollment: 672 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Takeda (Industry-sponsored)
• Locations: 1 site (Bristol, Southwestern England)
• Trial ID: NCT06568055 on ClinicalTrials.gov

What this trial studies

This observational study aims to retrospectively analyze data on cytomegalovirus (CMV) infection management in adults who have undergone kidney transplants in the UK over a seven-year period from 2017 to 2024. The study will estimate the prevalence and annual rate of refractory CMV infections and describe treatment effectiveness and tolerability. It will also examine the demographic and clinical characteristics of participants with both refractory and non-refractory CMV infections using data from the Registry of Rare Kidney Diseases (RaDaR). No new interventions will be administered, as the study will solely review existing clinical data.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are kidney transplant recipients with either refractory or non-refractory CMV infections.

Not a fit: Patients who have undergone multi-organ transplants or are participating in anti-CMV prophylaxis or treatment clinical trials since 2010 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of CMV infection management in kidney transplant recipients, potentially leading to improved treatment strategies.

How similar studies have performed: Other studies have explored CMV management in transplant populations, but this specific observational approach focusing on refractory cases is relatively novel.

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.

Where this trial is running

Bristol, Southwestern England

• RaDaR (part of the UK Kidney Association) — Bristol, Southwestern England, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Takeda Contact

Conditions Cytomegalovirus; Drug Therapy