Clazakizumab for Chronic and Active Antibody Mediated Rejection Post-Kidney Transplant (NCT03380377) | Clinical Trial Compass
CompletedPhase 1/2
Clazakizumab for Chronic and Active Antibody Mediated Rejection Post-Kidney Transplant
United States10 participantsStarted 2018-02-21
Plain-language summary
Antibody mediated rejection (ABMR) is a unique, significant and often severe form of allograft rejection. This single center, phase I/II, open label single-arm exploratory study focuses on enrolling ten patients with biopsy proven chronic antibody medicated rejection and/or donor specific antibody present at time of biopsy. Patients who qualify will be receiving clazakizumab (anti-IL6 monoclonal antibody) monthly x six doses. A protocol biopsy will be performed at 6 months and if improvement is seen, patients will continue another six doses for up to 12 months. For those completing 12 doses, there will be a 12 month protocol biopsy. For those who only received six doses, the next and last study visit will be at 12 months from enrollment. Total study duration is 12 months.
Who can participate
Age range
15 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 15-75 years at the time of screening.
. Biopsy proven cABMR with TG on biopsy as defined by Banff 2015 and DSA positive at time of biopsy
. Subject/Parent/Guardian must be able to understand and provide informed consent.
. Pneumococcal vaccinated
. Negative tuberculin ppd result or negative Quantiferon TB gold
Exclusion criteria
. Multi-organ transplant (e.g. kidney and pancreas)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Donor Specific Antibody (DSA) Elimination or Reduction Based on Luminex HLA Testing
Timeframe: 12 months
2
Number of Participants With Stabilization of Clinical Features of cABMR Via BANFF Biopsy Grading Criteria.
. Previous allergic reactions to monoclonal antibodies.
. Lactating or pregnant females.
. Women of child-bearing age who are not willing or able to practice FDA-approved forms of contraception during study and for 5 months after last dose.
. HIV-positive subjects.
. Subjects who test positive for HBV by HBVeAg/DNA or HCV infection \[positive Anti-HCV (EIA) and confirmatory HCV RIBA\].