Immune-guided versus universal antiviral prevention for CMV after kidney transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial enrolls adults who are CMV seropositive and have received a kidney transplant within 1–12 days, with non‑depleting induction (basiliximab) and no detectable CMV DNAemia at baseline. Participants are assigned to an immune‑guided prevention strategy—using immune and/or DNAemia monitoring to trigger antiviral therapy—or to universal prophylaxis with valganciclovir (Rovalcyte) for the first three months post‑transplant. The study follows patients through the early high‑risk post‑transplant period to record CMV DNAemia, CMV disease, and safety outcomes including blood count abnormalities. The aim is to see if targeted antiviral use can prevent CMV disease while reducing unnecessary drug exposure and toxicity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Renal transplant patient for 1 to 12 days
* CMV seropositivity on the day of transplantation: IgG threshold =6 AU/mL CMIA CMV IgG, Architect i4000 (Abbott)) (Serology performed on D0, before the transplant)
* Non-depleting inducing immunosuppressive treatment (Basiliximab) (implementation before the transplant)
* Affiliation to a social security scheme
* Patient having read and understood the information letter and signed the consent form

Exclusion Criteria:

* Active CMV infection (detectable CMV DNAemia - peripheral CMV DNAemia ≥ 305 IU/mL)
* Patient with hypersensitivity to valganciclovir, ganciclovir, aciclovir or valaciclovir or to any of the excipients
* Lympho-depleting inducing immunosuppressive treatment (antithymoglobulins)
* Neutropenia (neutrophils \< 500/mm3) or thrombocytopenia (platelets \< 25,000/mm3) or anemia (hemoglobin \< 8G/L) identified on routine care samples taken on the day of inclusion

Where it's running

• Chu Rouen
  Rouen, France Recruiting

Study contacts

• Study coordinator: Dominique Bertrand
• Email: dominique.bertrand@chu-rouen.fr
• Phone: 0232885452

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using letermovir to prevent CMV infection in kidney and pancreas transplant patients

  This study is testing if letermovir can help prevent CMV infections in adult kidney and pancreas transplant patients who are at high risk, while reducing their need for another medication called ganciclovir.

  Recruiting Phase 3 University of Wisconsin, Madison · Madison, Wisconsin · NCT06407232

• Comparing 7 days versus 14 days of antibiotics for kidney transplant patients with acute pyelonephritis

  This study is testing if kidney transplant patients with a certain type of kidney infection can be treated safely with just 7 days of antibiotics instead of the usual 14 days.

  Recruiting at 4 sites Phase 3 Assistance Publique - Hôpitaux de Paris · Bordeaux and 8 other locations · NCT05597540

• Treating BK Virus Infections in Kidney Transplant Recipients

  This study is testing if changing the way we manage immune suppression and giving a special treatment can help kidney transplant patients with BK virus infections feel better and keep their transplants healthy.

  Recruiting at 13 sites Phase 3 The University of Queensland · Canberra, Australian Capital Territory and 12 other locations · NCT05325008

• Understanding COVID-19 in kidney transplant recipients in Brazil

  This study looks at how COVID-19 affects kidney transplant patients in Brazil to see what challenges they face and what happens to them after getting the virus.

  Recruiting Hospital do Rim e Hipertensão · São Paulo, Aão Paulo · NCT04494776

• Omnisol-preserved kidneys before transplant (hypothermic machine perfusion)

  This study tests whether using Omnisol during hypothermic machine perfusion before kidney transplant can improve early graft function compared with standard preservation.

  Recruiting Vivalyx GmbH · Rotterdam · NCT07792317

• How Propofol and Sevoflurane Affect miRNA in Living Kidney Donors

  This study tests whether using propofol or sevoflurane during donor nephrectomy changes levels of miRNAs in living kidney donors.

  Recruiting University of Gaziantep · Gaziantep, Sahinbey · NCT07760402

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.