Synergy between T lymphocytes and anti-CMV immunoglobulins in the prevention of CMV infection.

Phase 1

• Conditions: CMV infection in transplantation; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2020-005582-13-FR
• Lead Sponsor: CHU de Bordeaux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-03
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1) Man or woman over 18 years old,
2) Patient candidate for a first transplant or re-transplantation, registered on the national waiting list of the Biomedicine Agency.
3) Patients seropositive for CMV (positive serology during the pre-transplant assessment or on D0 transplant)
4) Patients receiving a kidney transplant from a deceased donor or a living donor.
5) Women of childbearing age presenting a negative pregnancy test on inclusion and giving their consent to the establishment of effective contraception throughout the study period and two months after stopping the period of monitoring.
6) Patient affiliated or beneficiary of a social security insurance.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

1) Patients seronegative for CMV (R-).
2) Historical or current Incompatible Graft rate (TGI)> 85%.
3) Patients who received anti-CMV treatment within 28 days of transplantation.
4) Indication for induction therapy with anti-lymphocyte globulin, rituximab, polyvalent intravenous immunoglobulins or any other immunomodulatory molecule, and treatment with inhibitor mTOR, themselves described associated with a decrease in the incidence of CMV infections
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; Ag HbS positive) or hepatitis C virus (HCV; anti-HCV antibodies positive),
7) Allergy, contraindication or known intolerance to specific anti-CMV Ig, mycophenolic acid, basiliximab, corticosteroids, cyclosporine A, tacrolimus or to excipients of these products.
8) Any form of substance abuse, psychiatric disorder or any condition, which, according to the investigator, may complicate communication during follow-up.
9) Foreseeable inability to comply with the visits / check-ups planned in the protocol.
10) Patients under guardianship / curatorship

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified