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Efficiency of everolimus for the treatment of kidney transplanted patients presenting a rejection
EU CTIS ID: 2024-513814-37-00
What this study is testing
To evaluate the effectiveness of everolimus in preventing deterioration of graft function at 6 months in adult kidney transplant patients with NK-mediated rejection
- Therapeutic use (Phase IV)
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
- Major renal transplant patient
- Patient who had a renal graft biopsy as part of the usual follow-up finding microvascular inflammatory lesions (glomerulitis + peritubular capillaritis ≥ 2) associated with moderate chronic lesions (cg < 3 and cv < 3) according to the Banff classification 2013
- Having a predictable “missing self”: patient having a mismatch between the HLA class I ligands of inhibitory KIRs present in the recipient and the ligands present in the recipient
- Patient receiving at least dual immunosuppressive therapy including: an anticalcineurin (tacrolimus or cyclosporine), an antimetabolite (mycophenolic acid (CELLCEPT or MYFORTIC) or azathioprine (IMUREL)).
- Taking effective contraception for up to 8 weeks after the end of treatment with everolimus (CERTICAN)
- Patient affiliated to a social insurance regimen
You likely can't join if
- - Patients at high immunological risk: presence of preformed specific anti-HLA antibodies or hyperimmunized patients (incompatible graft rate > 85%) on the day of the transplant.
- - Subject participating in another research including an exclusion period still in progress at pre-inclusion
- Pregnant, breastfeeding women, minors, adults under guardianship or curatorship
- - Proteinuria > 1 g/day (or 100 mg/mmol creatininuria)
- - History of poor tolerance of everolimus
- Hypersensitivity to everolimus, sirolimus or one of its excipients as mentioned in the SPC of everolimus paragraph 4.3 and 6.1.
See the full eligibility criteria
- Major renal transplant patient
- Patient who had a renal graft biopsy as part of the usual follow-up finding microvascular inflammatory lesions (glomerulitis + peritubular capillaritis ≥ 2) associated with moderate chronic lesions (cg < 3 and cv < 3) according to the Banff classification 2013
- Having a predictable “missing self”: patient having a mismatch between the HLA class I ligands of inhibitory KIRs present in the recipient and the ligands present in the recipient
- Patient receiving at least dual immunosuppressive therapy including: an anticalcineurin (tacrolimus or cyclosporine), an antimetabolite (mycophenolic acid (CELLCEPT or MYFORTIC) or azathioprine (IMUREL)).
- Taking effective contraception for up to 8 weeks after the end of treatment with everolimus (CERTICAN)
- Patient affiliated to a social insurance regimen
- An absence of anti-endothelial cell antibodies in their serum tested for by an endothelial cross match
- At least 1 confirmed missing self: the recipient has at least one functional KIR inhibitor present genotypically whose HLA class I ligand is not present in the donor
- - Patients at high immunological risk: presence of preformed specific anti-HLA antibodies or hyperimmunized patients (incompatible graft rate > 85%) on the day of the transplant.
- - Subject participating in another research including an exclusion period still in progress at pre-inclusion
- Pregnant, breastfeeding women, minors, adults under guardianship or curatorship
- - Proteinuria > 1 g/day (or 100 mg/mmol creatininuria)
- - History of poor tolerance of everolimus
- Hypersensitivity to everolimus, sirolimus or one of its excipients as mentioned in the SPC of everolimus paragraph 4.3 and 6.1.
- - Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome
- Surgery planned for the next 6 months
- - Severe chronic lesions (cg > 2 or cv > 2) according to the Banff 2013 classification on the classic histological examination of a graft biopsy
- - Presence of donor-specific anti-HLA antibodies in their serum on the day of the biopsy searched by Luminex
- Positive endothelial cross match with serum from the day of the biopsy
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, 18-64 years, 65+ 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.