Using Everolimus to Treat Kidney Transplant Patients with Unique Rejection Issues
Efficiency of Everolimus for the Treatment of Kidney Transplanted Patients Presenting a Missing Self-induced Natural Killer Cells Mediated (NK-mediated) Rejection
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT03955172 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include kidney transplant patients over 18 years old with specific microvascular inflammation lesions and no donor-specific antibodies.
Not a fit: Patients with severe chronic lesions, significant proteinuria, or a history of hypersensitivity to Everolimus may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lyon
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.