Treatment of Chronic Active Antibody Mediated Rejection With Tocilizumab

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShahid Beheshti University of Medical Sciences

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Signed written informed consent

eGFR> 25 cc/min

Chronicity index <8

IFTA<40%

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tocilizumab

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Standard of careNo intervention 0 interventions
Group B: InterventionOther 1 intervention

Trial outcomes

Primary outcomes

1

GFR

cc/min/1.73 m

Time frame
through study completion, an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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