Immune test-guided prevention of cytomegalovirus infection after kidney transplant

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who had a kidney transplant 1 to 12 days ago and who already carried CMV (cytomegalovirus) before the transplant. It compares two ways to prevent CMV infection.

Age

18 Years to 75 Years

Sex

All sexes can join.

Disease stage

Kidney transplant done 1 to 12 days before joining.

Earlier treatment

Must have had Basiliximab before the transplant to start immune-lowering treatment. People who had antithymoglobulins (a type of immune-lowering treatment that lowers white blood cells) cannot join.

Biomarker or test result

Positive CMV blood test (IgG threshold =6 AU/mL) on the day of the transplant, done before the transplant.

Main reasons for not taking part

• Active CMV infection (CMV DNA in the blood ≥ 305 IU/mL)
• Allergy to valganciclovir, ganciclovir, aciclovir or valaciclovir, or their other ingredients
• Treatment with antithymoglobulins
• Very low neutrophils (< 500/mm3), platelets (< 25,000/mm3) or hemoglobin (< 8G/L) on the day of inclusion
• No social security coverage

This trial only enrols participants who have had an organ transplant. The registry sentence this rests on: * Renal transplant patient for 1 to 12 days

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 75 years old?YesNo

What the trial wants to find out

Cytomegalovirus (CMV) establishes a chronic infection in 60% of the general population. In renal transplant recipients, it is responsible for morbidities occurring mainly in the first 6 months after transplantation. These include viral reactivations linked to immunosuppressive treatment inhibiting the anti-CMV T lymphocyte response. CMV infection, a sign of uncontrolled viral replication, is defined by the detection of viral DNA in the peripheral blood (DNAemia). CMV disease is defined as the association of an infection and symptoms attributable to the virus.

The 2 groups in the trial

• "Immuno-guided strategy" armTreatment being tested

  Participants randomized to the immuno-guided strategy arm will receive a cytomegalovirus (CMV) prevention strategy based on anti-CMV immune response assessment at Day 15 post-transplant. * Participants classified as low risk will not receive systematic antiviral prophylaxis and will undergo preemptive monitoring for CMV infection from Day 15 to Week 28 post-transplant. * Participants classified as high risk (anti-CMV immune response \<130 SFC/10⁶ cells) will receive antiviral prophylaxis with valganciclovir starting at Day 15 post-transplant. At Week 15, antiviral treatment will be discontinued in participants reclassified as low risk. Participants remaining classified as high risk will continue antiviral treatment until Week 28 post-transplant.

  Treatment: ROVALCYTE

• "Universal prophylaxis" armExisting treatment, for comparison

  Participants randomized to the universal prophylaxis arm will receive antiviral prophylaxis with valganciclovir starting at Day 15 post-transplant and continuing for 3 months following transplantation. Participants will undergo standard clinical and biological monitoring, including CMV DNAemia surveillance, for up to 6 months post-transplant according to routine practice at the participating centers.

  Treatment: ROVALCYTE