RecruitingNot ApplicableNCT07006532

Treatment of Chronic Active Antibody Mediated Rejection With Tocilizumab

Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients With Tocilizumab ,IVIG, Plasmapheresis, Rituximab Versus IVIG, Plasmapheresis , Rituximab

Sponsor

Shahid Beheshti University of Medical Sciences

Enrollment

50 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Kidney Transplant Rejection

Summary

Chronic active antibody mediated rejection (CAMR) is a therapeutic challenge in transplant recipients that does not respond well to conventional treatments for acute antibody mediated rejection (AMR). Annually, 5000 kidney transplants are lost in the United States due to CAMR. The two-year graft survival rate in CAMR is approximately 20%, highlighting the need for a more efficient therapy for CAMR and directly targeting donor specific antibody (DSA) producing cells and reducing CAMRThere is no established treatment for this problem. While many centers intensify and optimize the dosage of immunosuppressive drugs, treatments such as plasmapheresis, IVIG, and rituximab, although effective in treating AMR, have not been successful in reducing DSA or improving kidney graft survival in CAMR patients. Despite these treatments, two-year graft survival can increase up to 55%. The use of anti-plasma cell treatments like bortezomib has also yielded inconsistent results.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Signed written informed consent
eGFR\> 25 cc/min
Chronicity index \<8
IFTA\<40%
EBV IgG positive

Exclusion Criteria4

Active or recurrent infections
History of malignancy, unless in remission for more than 2 years with no relapse
abnormal liver function tests
Platelet \< 100,000

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Interventions

DRUGTocilizumab

The trial is an open-labeled randomized clinical trial that evaluates the safety and efficacy of Tocilizumab as an add-on therapy to standard of care treatment of Plasmapheresis, IVIG, and Rituximab in treatment of CAMR in kidney transplant recipients.