Treatment of Chronic Active Antibody Mediated Rejection With Tocilizumab

Not Applicable

Recruiting

• Conditions: Kidney Transplant Rejection
• Interventions: Drug: Tocilizumab

• Registration Number: NCT07006532
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2025-01-01
• Study First Submitted: 2025-05-27
• Study First Submitted QC: 2025-05-27
• Status Verified: 2025-06
• Study First Posted: 2025-06-05
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-10
• Primary Completion: 2026-01-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Signed written informed consent
2. eGFR> 25 cc/min
3. Chronicity index <8
4. IFTA<40%
5. EBV IgG positive

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Tocilizumab	Standard of care plus Tocilizumab

Primary Outcome Measures

Name	Time	Method
GFR	through study completion, an average of 1 year	cc/min/1.73 m

Trial Locations

Locations (1)

Nooshin Dalili; 🇮🇷 Tehran, Iran, Islamic Republic of