Actively Recruiting
Efficiency of Everolimus for the Treatment of Kidney Transplanted Patients Presenting a Missing Self-induced Natural Killer Cells Mediated (NK-mediated) Rejection
Led by Hospices Civils de Lyon · Updated on 2024-06-06
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying kidney transplant patients who experience a particular kind of rejection involving natural killer (NK) cells. This rejection happens when the body's NK cells detect missing self markers on the transplanted kidney, which may lead to chronic vascular damage. The study aims to evaluate the effectiveness of a drug called everolimus, an mTOR inhibitor, in treating this NK cell-mediated rejection and improving graft function. Participants will receive everolimus orally for six months, with the dose adjusted to maintain specific blood levels. This drug will replace their previous anti-proliferative medication (such as azathioprine or mycophenolic acid) while continuing treatment with corticosteroids and a calcineurin inhibitor. The study involves monitoring patients during this six-month treatment period to assess the effects of adding everolimus. During the study, researchers will track kidney function by measuring the estimated glomerular filtration rate, examine biopsy samples to assess rejection lesions, evaluate NK cell activity, and monitor protein levels in urine. These assessments will be done before and after the six-month treatment period to understand how the drug affects the rejection process and kidney health.
CONDITIONS
Brief Title
Efficiency of Everolimus for the Treatment of Kidney Transplanted Patients Presenting a Missing Self-induced NK-mediated Rejection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Proteinuria/urinary creatinin > 100 mg/mmol
- Antecedent of poor tolerance or hypersensibility to everolimus or sirolimus
- Severe chronic lesions
- Presence of donor specific antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants receive everolimus orally to replace their previous anti-proliferative drug, along with corticosteroids and a calcineurin inhibitor, for 6 months.
Trial Site Locations
Total: 1 location
1
Service de transplantation, néphrologie et immunologie clinique, Hôpital Edouard Herriot (HCL)
Lyon, France, 69003
Actively Recruiting
Research Team
A
Alice KOENIG, MD
D
Daniel SPERANDIO, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here