Kidney Transplant RejectionNCT07006532
Treatment of Chronic Active Antibody Mediated Rejection With Tocilizumab
A study testing Tocilizumab in people with Kidney Transplant Rejection, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- Tocilizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2025to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- eGFR> 25 cc/min
- Chronicity index <8
- IFTA<40%
- EBV IgG positive
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
PI contact
Iran1 site, 1 recruiting
- Recruiting
Nooshin Dalili
Tehran, 1666663421
Nooshin Dalili, Dr, 00989122404331, nooshindalili4@gmail.com
About this study
Official title: Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients With Tocilizumab ,IVIG, Plasmapheresis, Rituximab Versus IVIG, Plasmapheresis , Rituximab
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.
Read the 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.
- Conditions
- Kidney Transplant Rejection
- Being tested
- Tocilizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
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 group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Plasmapheresis plus Rituximab plus IVIG |
| Intervention | Other | Standard of care plus Tocilizumab Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
GFR
cc/min/1.73 m
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nooshin dalili, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006532
- Sponsor's protocol ID
- SBMU-1404-2/2
- Status last verified
- Feb 2026
- First submitted
- 27 May 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients With Tocilizumab ,IVIG, Plasmapheresis, Rituximab Versus IVIG, Plasmapheresis , Rituximab
- ClinicalTrials.gov ID
- NCT07006532
- Acronym / sponsor ID
- SBMU-1404-2/2
- Conditions
- Kidney Transplant Rejection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Plasmapheresis plus Rituximab plus IVIG |
| Intervention | Other | Drug: TocilizumabStandard of care plus Tocilizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed written informed consent
- eGFR> 25 cc/min
- Chronicity index <8
- IFTA<40%
- EBV IgG positive
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocilizumabThe 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. | Drug | Intervention |
Primary outcome
GFR
Time frame: through study completion, an average of 1 year
cc/min/1.73 m
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
PI contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tocilizumab in people with Kidney Transplant Rejection, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PI (00989122404331, dr.nooshindalili@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GFR (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.