Using Everolimus to Treat Kidney Transplant Patients with Unique Rejection Issues
Official title: Efficiency of Everolimus for the Treatment of Kidney Transplanted Patients Presenting a Missing Self-induced Natural Killer Cells Mediated (NK-mediated) Rejection
Run by Hospices Civils de Lyon · NCT03955172 · Data updated 2026-11-12
This study is testing if the drug Everolimus can help kidney transplant patients who have a specific type of rejection that isn't well understood, to see if it improves their kidney function and overall health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Status | Recruiting |
| Started | December 3, 2020 |
| Main results expected | December 3, 2027 |
| Study ends | December 3, 2027 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT03955172 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include kidney transplant patients over 18 years old with specific microvascular inflammation lesions and no donor-specific antibodies.
✕Probably not a fit
Patients with severe chronic lesions, significant proteinuria, or a history of hypersensitivity to Everolimus may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of Everolimus, an mTOR inhibitor, in kidney transplant patients who exhibit a specific type of rejection characterized by missing self-induced NK cell activity. The research aims to address the limitations of current understanding of organ rejection, which traditionally focuses on the adaptive immune response. By targeting innate immune mechanisms, the study seeks to improve graft function and patient outcomes in those with microvascular inflammation and mild chronic lesions without donor-specific antibodies. The approach is based on previous findings that suggest mTOR inhibitors can prevent this novel rejection type.
Why it matters
Potential benefit: If successful, this treatment could enhance the long-term success of kidney transplants by addressing a previously overlooked mechanism of rejection.
How similar studies have gone: While the approach of targeting innate immune mechanisms in transplant rejection is relatively novel, previous studies have shown promise in using mTOR inhibitors for similar conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged \> 18 years * Kidney transplanted patient * Having microvascular inflammation lesion on his graft biopsy associated to mild chronic lesions * In absence of donor specific antibodies * In presence of a missing self Exclusion Criteria: * Proteinuria/urinary creatinin \> 100 mg/mmol * Antecedent of poor tolerance or hypersensibility to everolimus or sirolimus * Severe chronic lesions * Presence of donor specific antibodies
Where it's running
-
Service de transplantation, néphrologie et immunologie clinique, Hôpital Edouard Herriot (HCL)
Lyon, France Recruiting
Study contacts
- Study coordinator: Alice KOENIG, MD
- Email: alice.koenig@chu-lyon.fr
- Phone: 472110178
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Inducing immunological tolerance in kidney transplant patients using stem cell infusion
This study is testing whether giving stem cells from the same donor to kidney transplant patients can help them stop taking their immunosuppressive medications safely.
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Treating BK Virus Infections in Kidney Transplant Recipients
This study is testing if changing the way we manage immune suppression and giving a special treatment can help kidney transplant patients with BK virus infections feel better and keep their transplants healthy.
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Investigating tacrolimus metabolism in kidney transplant patients
This study looks at how kidney transplant patients process a medication called tacrolimus over four years to see if it affects their kidney health and how genetics might play a role.
-
Belimumab to mobilize memory B cells to help delistings for highly sensitized kidney transplant candidates
A short belimumab course is being tested to see if it can reveal memory B cells that target donor HLAs, helping to decide which donors to exclude and potentially speed up getting a transplant for highly sensitized patients.
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Frexalimab versus tacrolimus to prevent kidney transplant rejection
This trial will test whether frexalimab injections given for up to five years work as well and are as safe as tacrolimus capsules at preventing rejection in adults getting their first kidney transplant who have low-to-moderate immune risk.
-
Platelet aggregation for diagnosing acute kidney transplant rejection
This study will test whether changes in platelet activation measured from blood can help detect acute rejection in adult kidney transplant recipients.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.