New immune duo shows promise in preventing Post-Transplant infection
NCT ID NCT04934527
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new way to prevent CMV infection in 42 CMV-positive kidney transplant patients. Researchers combined an antibody infusion with a specific type of immune cell (gamma delta T cells) to see if it could stop the virus from reactivating. The goal was to find a safer alternative to standard antiviral drugs.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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42 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female over 18 years of age, 2. Patient candidate for a first transplant or a re-transplantation, registered on the national waiting list of the Biomedicine Agency. 3. CMV seropositive patients (positive serology at pre-transplant assessment or at D0 of transplantation) 4. Patients receiving a kidney transplant from a deceased or living donor. 5. Women of childbearing age with a negative pregnancy test at inclusion and agreeing to the use of effective contraception throughout the study period and two months after the end of the follow-up period. 6. Patient affiliated to or benefiting from a social security scheme. Exclusion Criteria: 1. CMV negative (R-) patients. 2. Historical or current Graft Incompatible Rate (GIR) \> 85%. 3. Patients who have received anti-CMV therapy within 28 days prior to transplantation. 4. Indication for induction therapy with anti-lymphocyte globulin, rituximab, polyvalent intravenous immunoglobulin or any other immunomodulatory molecule, and mTOR inhibitor therapy, which have been described to be associated with a decreased incidence of CMV infection 5. Patients who have received or are receiving a solid organ transplant other than a kidney transplant. 6. Patients known to be seropositive for human immunodeficiency virus (HIV), hepatitis B virus (HBV; HbS Ag positive) or hepatitis C virus (HCV; HCV antibody positive), 7. Known allergy, contraindication or intolerance to specific anti-HCV Ig, mycophenolic acid, basiliximab, corticosteroids, cyclosporine A, tacrolimus or to excipients of these products. 8. Any form of substance abuse, psychiatric disorder or condition that, in the opinion of the investigator, may complicate communication during follow-up. 9. Foreseeable inability to comply with planned protocol visits/reviews. 10. Patients under guardianship/guardianship 11. Pregnant or breastfeeding woman 12. Patients with a contraindication to receiving Cytotect
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hopital Pellegrin
Bordeaux, 33000, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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