Comparing two treatments for chronic-active antibody-mediated rejection in kidney transplant patients
Comparison Between Rituximab + PLX + IVIG With and Without Bortezomib in the Treatment of Antibody Mediated Kidney Transplanted Rejection
This study is testing if adding bortezomib to a standard treatment can help kidney transplant patients with chronic-active antibody-mediated rejection feel better and keep their kidneys working longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | Shahid Beheshti University of Medical Sciences Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Tehran) |
| Trial ID | NCT03737136 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a treatment regimen combining plasmapheresis, intravenous immunoglobulins, and rituximab with or without bortezomib in kidney transplant recipients diagnosed with chronic-active antibody-mediated rejection (cAMR). The study will involve 20 participants who will be randomly assigned to one of two treatment groups: one receiving the standard therapy and the other receiving the same therapy plus bortezomib. The primary outcomes will include kidney survival rates and functional outcomes assessed six months after diagnosis, along with histological features and donor-specific antibody characteristics. This approach seeks to improve treatment options for patients suffering from cAMR, a significant cause of allograft loss.
Who should consider this trial
Good fit: Ideal candidates for this study are kidney transplant recipients diagnosed with chronic-active antibody-mediated rejection without T-cell-mediated rejection.
Not a fit: Patients with mixed antibody-mediated rejection and T-cell rejection or those who do not consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients experiencing chronic-active antibody-mediated rejection after kidney transplantation.
How similar studies have performed: While the use of bortezomib in this context is relatively novel, previous studies have shown success with similar therapeutic regimens for acute antibody-mediated rejection.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients presented with renal biopsy demonstrating ABMR in the absence of T-cell-mediated rejection Exclusion Criteria: * Mixed AMR and T cell rejection * do not sign the consent
Where this trial is running
Tehran
- Sbmu — Tehran, Iran, Islamic Republic of (Recruiting)
Study contacts
- Principal investigator: Shahid Beheshti MU sbmu — Shahid Beheshti University of Medical Sciences
- Study coordinator: Nooshin Dalili, Dr
- Email: nooshindalili4@gmail.com
- Phone: 00989122404331
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.