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Effectiveness of a preventive strategy for cytomegalovirus infection guided differently from a universal prophylactic strategy in kidney transplant patients - CYTOPREV
EU CTIS ID: 2024-515925-27-00
What this study is testing
Demonstrate, in CMV+ transplant patients, the effectiveness of an immuno-guided preventive strategy compared to the universal prophylactic strategy, in terms of CMV infection in the 6 months following kidney transplantation.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18 years ≤ Age ≤ 75 years
- 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
You likely can't join if
- Age < 18 or > 75
- 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/dl) identified on routine care samples taken on the day of inclusion
- Pregnant or parturient or breast-feeding woman or absence of proven contraception
See the full eligibility criteria
- 18 years ≤ Age ≤ 75 years
- 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
- For women: - Woman of childbearing potential using effective contraception (Cf. CTFG) (estrogen-progestin or intrauterine device or tubal ligation) for at least 1 month and a negative β-HCG blood pregnancy test at inclusion, throughout the duration of study treatment and for at least 30 days after stopping study treatment. - Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months before the inclusion visit) - Surgically sterile woman (absence of ovary and/or uterus)
- Pour les hommes : - Stérilité chirurgicale, ou - Contraception mécanique (préservatif) pendant toute la durée du traitement à l’étude et pendant au moins 90 jours après la fin du traitement à l’étude, ou - Avec une partenaire en âge de procréer prenant une contraception efficace (Cf. CTFG) (oestro-progestatifs ou dispositif intra-utérin ou ligature de trompes) depuis au moins 1 mois à l’inclusion, pendant toute la durée du traitement à l’étude et pendant au moins 90 jours après l’arrêt du traitement, ou - Avec une partenaire ménopausée : diagnostic de confirmation (aménorrhée non médicalement induite depuis au moins 12 mois avant la visite d’inclusion), ou - Avec une partenaire chirurgicalement stérile (absence d’ovaire et/ou d’utérus).
- Age < 18 or > 75
- 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/dl) identified on routine care samples taken on the day of inclusion
- Pregnant or parturient or breast-feeding woman or absence of proven contraception
- Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship
- History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for their participation in the protocol or preventing them from giving their informed consent
- Person participating in another interventional trial (Medicinal product)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.