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RECRUITING
NCT07006532
NA

Treatment of Chronic Active Antibody Mediated Rejection With Tocilizumab

Sponsor: Shahid Beheshti University of Medical Sciences

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-01-01

Completion Date

2027-05-01

Last Updated

2026-02-11

Healthy Volunteers

No

Interventions

DRUG

Tocilizumab

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.

Locations (1)

Nooshin Dalili

Tehran, Iran