Treatment of Chronic Active Antibody Mediated Rejection With Tocilizumab
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2025
CompletedFirst Submitted
Initial submission to the registry
May 27, 2025
CompletedFirst Posted
Study publicly available on registry
June 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
February 11, 2026
February 1, 2026
2 years
May 27, 2025
February 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
GFR
cc/min/1.73 m
through study completion, an average of 1 year
Study Arms (2)
Standard of care
NO INTERVENTIONPlasmapheresis plus Rituximab plus IVIG
Intervention
OTHERStandard of care plus Tocilizumab
Interventions
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.
Eligibility Criteria
You may qualify if:
- Signed written informed consent
- eGFR\> 25 cc/min
- Chronicity index \<8
- IFTA\<40%
- EBV IgG positive
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nooshin Dalili
Tehran, 1666663421, Iran
MeSH Terms
Interventions
Central Study Contacts
PI
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
May 27, 2025
First Posted
June 5, 2025
Study Start
January 1, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
February 11, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share