Using Tocilizumab to Reduce Allo-sensitization After Kidney Graft Removal
Evaluation of the Safety of Use of Anti-IL6 Receptor Antibodies to Reduce Allo-sensitization Post Allograft Nephrectomy ; a Pilot Phase II Study.
PHASE2 · University Hospital, Toulouse · NCT04779957
This study is testing if giving a single dose of Tocilizumab before or after kidney graft removal can help prevent serious infections and reduce antibody levels in kidney transplant patients who may need another transplant later.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse (other) |
| Drugs / interventions | Rituximab, Eculizumab, Tocilizumab |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT04779957 on ClinicalTrials.gov |
What this trial studies
This phase II pilot study evaluates the safety of a single dose of Tocilizumab, an anti-IL6 receptor antibody, administered before or after graft nephrectomy in adult kidney transplant recipients. The study aims to assess the occurrence of serious infectious complications following nephrectomy and the effectiveness of Tocilizumab in reducing anti-HLA antibodies one year post-surgery. By targeting the inflammatory response associated with graft nephrectomy, the study seeks to improve outcomes for patients requiring retransplantation.
Who should consider this trial
Good fit: Ideal candidates are adult kidney transplant recipients who require a graft nephrectomy and have plans for retransplantation.
Not a fit: Patients with combined transplantations, high panel-reactive antibody levels, or active infections at the time of nephrectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of allo-sensitization and improve the chances of successful kidney retransplantation.
How similar studies have performed: While the use of Tocilizumab has shown promise in reducing allo-antibodies in kidney transplantation, this specific application post-nephrectomy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult recipients, * affiliated to the social security * requiring a graft nephrectomy, with a project to retransplantation Exclusion Criteria: * combined transplantations, PRA \>20%. * Patient under protective measures, * Rituximab used for immunosuppression induction * Previous transplants not removed, * Active infectious complications at graft nephrectomy, need for immunosuppressive treatments after graft nephrectomy, * Participation to another interventional studies using Rituximab, polyclonal antibodies, Eculizumab, or Tocilizumab. * adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision, * pregnancy or breastfeeding.
Where this trial is running
Toulouse
- CHU Toulouse — Toulouse, France (RECRUITING)
Study contacts
- Principal investigator: Arnaud DEL BELLO, MD — University Hospital, Toulouse
- Study coordinator: Arnaud DEL BELLO, MD
- Email: delbello.a@chu-toulouse.fr
- Phone: 0561323923
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.
Conditions: Kidney Transplantation, Graft Failure, Kidney transplantation, allosensitization, graft nephrectomy, Donor-Specific Antibodies