Status:
COMPLETED
A Pilot Trial of Clazakizumab in Late ABMR
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
CSL Behring
University of Alberta
Conditions:
Antibody-mediated Rejection
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief 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...
Detailed Description
Part A: Patients positive for anti-HLA donor-specific antibodies (DSA) and with biopsy-proven late ABMR (Acute/active or chronic/active phenotype according to the Banff 2015 classification) will be i...
Eligibility Criteria
Inclusion
- 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
- 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 inflammatory bowel disease
- Allergy against proton pump inhibitors
- History of alcohol or illicit substance abuse
- Serious medical or psychiatric illness likely to interfere with participation in the study
Key Trial Info
Start Date :
January 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03444103
Start Date
January 16 2018
End Date
June 30 2020
Last Update
September 9 2020
Active Locations (2)
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1
Medical University of Vienna
Vienna, Austria, 1090
2
Charité University
Berlin, Germany, 10117