A Pilot Trial of Clazakizumab in Late ABMR (NCT03444103) | Clinical Trial Compass
CompletedPhase 2
A Pilot Trial of Clazakizumab in Late ABMR
Austria, Germany20 participantsStarted 2018-01-16
Plain-language summary
This bi-center study (Medical University of Vienna \& Charité Berlin) is an investigator-driven pilot trial designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy (preliminary assessment) of humanized anti-IL-6 monoclonal antibody clazakizumab in kidney transplant recipients with late antibody-mediated rejection (ABMR). The study is designed as a phase 2 trial and has two subsequent sub-parts, a randomized placebo-controlled trial (part A) of 12 weeks, where recipients are allocated to receive either anti-IL-6 antibody clazakizumab (n=10) or placebo (n=10), followed by an open-label prospective study, where all 20 study patients will receive clazakizumab for a period of 40 weeks. Study protocol biopsies will be performed at the end of part A and part B.
Who can participate
Age range
18 Years – 100 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:
* Voluntary written informed consent
* Age \>18 years
* Functioning living or deceased donor allograft after ≥365 days post-transplantation
* eGFR \>30 ml/min/1.73 m2
* Detection of HLA class I and/or II antigen-specific antibodies (preformed and/or de novo DSA).
* Acute/active or chronic/active ABMR (±C4d in PTC) according to Banff 2013/2015
* Molecular ABMR score (ABMRpm) ≥0.2
Exclusion Criteria:
* Patients actively participating in another clinical trial
* Age ≤18 years
* Female subject is pregnant or lactating
* Index biopsy results:
* T-cell-mediated rejection classified Banff grade ≥I
* De novo or recurrent severe thrombotic microangiopathy
* Polyoma virus nephropathy
* De novo or recurrent glomerulonephritis
* Acute rejection treatment \<3 month before screening
* Acute deterioration of graft function (eGFR decline within 1-3 months \>25%)
* Nephrotic range proteinuria \>3500 mg/g protein/creatinine ratio
* Active viral, bacterial or fungal infection precluding intensified immunosuppression
* Active malignant disease precluding intensified immunosuppressive therapy
* Abnormal liver function tests (ALT, AST, bilirubin \> 1.5 x upper limit of normal)
* Other significant liver disease
* Latent or active tuberculosis (positive QuantiFERON-TB-Gold test, Chest X-ray)
* Administration of a live vaccine within 6 weeks of screening
* Neutropenia (\<1 G/L) or thrombocytopenia (\<100 G/L)
* History of gastrointestinal perforation, diverticulitis, or inflamm…
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 adverse events and severe adverse events (AE's, SAE's)