Optimal Dose of Anti-lymphocyte Globulin in Kidney Transplant Recipients With Low Immunological Risk

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE BESANCON · Dec 16, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to find the best dose of a medication called anti-lymphocyte globulin (Grafalon®) for patients receiving a kidney transplant who have a low risk of rejection. The goal is to see if a lower dose can still help prevent complications related to low levels of certain immune cells after the transplant, which can lead to a higher risk of infections and other health issues. The study will include adult patients from the Besançon transplant unit who are having their first kidney transplant and meet specific criteria, like being 18 years or older and not having a history of certain high-risk factors.

Participants in the study can expect to receive treatment starting on the day of their transplant and will have regular check-ups to monitor their health and the effects of the medication over a year. The study will last a total of two years, with one year focused on enrolling patients and another year for follow-up. It’s important to note that this trial is not yet recruiting patients, but it will be an opportunity for those who qualify to contribute to important research that could improve kidney transplant outcomes for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• * Females must be using highly effective contraceptive measures (see Section V-9), and have a negative pregnancy test prior to the start of dosing if of childbearing potential, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening :
• • Post-menopausal is defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.
• • Women under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution.
• • Women with documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
• • Male patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and for 6 months following discontinuation of study drug. Patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing study treatment.
• • Patient affiliated to or beneficiary of French social security system
• • Signed and dates informed consent
• • Patient receiving first kidney transplantation
• Exclusion Criteria:
• • Current participation in a study of an investigational agent or in the period of exclusion
• • Pregnant or breast-feeding subjects,
• • Patient under guardianship, curatorship or under the protection of justice
• • Subject not able to cooperate properly in the study judged by the investigator.
• • Patients with bacterial, viral or mycotic and parasitic infections,History of opportunistic infection that required intensive care hospitalization in the two years preceding the transplant
• * Patients with a high immunological risk of rejection:
• • African-American ethnicity
• • Presence of a donor-specific antibody
• • Blood group incompatibility
• • Delayed onset of graft function (i.e donor after cardiac death)
• • Cold ischemia time \>24 hours
• • Anti-HLA immunization (Flow PRA \> or = 20%, presence of donor specific antibody before and/or at time of transplantation and with a positive CDC and FXM with historical and/or transplant day sera)
• • Related donor with two-haplotype HLA matched kidneys
• • Multi-organ transplant
• • Previous transplant(s)
• • History of cancer
• • Thrombocytopenia \< 50 000 platelets/µl
• • Hypersensitivity to the active substance or to the excipients of Grafalon (monosodium phosphate dihydrate, phosphoric acid).