Evaluating T-cell response in patients with chronic kidney disease
Assessment of T-cell Response and In-vitro Proof-of-concept of T-cell Engineering in Chronic End-stage Kidney Disease Patients.
This study is trying to understand how the immune system works in patients with end-stage kidney disease to see if improving T-cell function can help reduce their risk of infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Régional d'Orléans Academic / other |
| Drugs / interventions | Rituximab, Eculizumab |
| Locations | 1 site (Orléans) |
| Trial ID | NCT06474169 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the immune response in patients suffering from chronic kidney disease, particularly focusing on those with end-stage kidney disease (ESKD). It seeks to define the immunodeficiency characteristics of T cells in these patients and provide an in-vitro proof-of-concept for T-cell engineering. By analyzing blood samples, the study will explore the relationship between T-cell function and the increased risk of infections in ESKD patients, which is a significant cause of mortality in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with chronic kidney disease, particularly those at the end-stage.
Not a fit: Patients with chronic progressive infections, prior organ transplants, or those who have received immunosuppressive treatments in the last two years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of immune deficiencies in chronic kidney disease patients, potentially reducing infection-related complications.
How similar studies have performed: While the approach of assessing T-cell responses in ESKD is relatively novel, similar studies have shown promise in understanding immune responses in other chronic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female ≥ 18 years 2. Informed participants who did not object to participating in the study Exclusion Criteria: 1. Chronic progressive infections 2. Prior organ transplantation (including bone marrow transplantation) 3. Previous treatment with immunosuppressive agents (such as Rituximab, Eculizumab, Tacrolimus or Ciclosporin, Cellcept or Imurel) within 2 years prior to inclusion 4. Participant under guardianship, curatorship or deprived of liberty 5. Pregnant or breastfeeding women
Where this trial is running
Orléans
- Center Hospitalier Universitaire d'Orléans — Orléans, France (Recruiting)
Study contacts
- Study coordinator: Manon DEKEYSER, PhD
- Email: manon.dekeyser@chu-orleans.fr
- Phone: +33238229870
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.