Treatment of Chronic Active Antibody Mediated Rejection With Tocilizumab

Shahid Beheshti University of Medical Sciences

Status: Enrolling

Conditions: Kidney Transplant Rejection

Treatments: Drug: Tocilizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT07006532

SBMU-1404-2/2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Standard of care

No Intervention group

Description:

Plasmapheresis plus Rituximab plus IVIG

Intervention

Other group

Description:

Standard of care plus Tocilizumab

Treatment:

Drug: Tocilizumab