Treatment of Chronic Active Antibody Mediated Rejection With Tocilizumab

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-05-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Kidney Transplant Rejection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard of care

Plasmapheresis plus Rituximab plus IVIG

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Standard of care plus Tocilizumab

Group Type OTHER

Tocilizumab

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No