Adults 18 to 75, any sex, with Antibody-mediated Rejection. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline to Week 52 in Estimated Glomerular Filtration Rate (eGFR)Primary· From Baseline to Week 52
This primary outcome measure was the one from the first interim analysis.
Group
Value
95% CI
Clazakizumab
-8.0
-10.2 – -5.8
Placebo
-5.2
-7.4 – -3.1
Number of Participants With Composite All-cause Allograft Loss or Irreversible Loss of Allograft FunctionPrimary· From Baseline to 4 years
Composite all-cause allograft loss or irreversible loss of allograft function, defined as time to first occurrence of any of the following components:
* eGFR \< 15 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2)\*
* return to dialysis\*
* allograft nephrectomy
* retransplantation
* death from any cause, or
* a sustained (greater than or equal to \[\>=\] 60 days) 40% decline in eGFR from Baseline.
(\*Total cumulative duration of sustained eGFR \< 15 mL/min/1.73 m\^2 AND / OR dialysis \>= 60 days.)
If the eGFR \< 15 mL/min/1.73 m\^2 was the only component reached, the value m
Group
Value
95% CI
Clazakizumab
26
Placebo
22
Percentage of Participants With Composite All-cause Allograft Loss or Irreversible Loss of Allograft FunctionPrimary· From Baseline to 4 years
Composite all-cause allograft loss or irreversible loss of allograft function, defined as time to first occurrence of any of the following components:
* eGFR \< 15 mL/min/1.73 m\^2\*
* return to dialysis\*
* allograft nephrectomy
* retransplantation
* death from any cause, or
* a sustained (greater than or equal to \[\>=\] 60 days) 40% decline in eGFR from Baseline.
(\*Total cumulative duration of sustained eGFR \< 15 mL/min/1.73 m\^2 AND / OR dialysis \>= 60 days.)
If the eGFR \< 15 mL/min/1.73 m\^2 was the only component reached, the value must be sustained over at least 60 days and must
Group
Value
95% CI
Clazakizumab
28.3
Placebo
22.2
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and Adverse Events of Special Interest (AESIs)Primary· Up to 4 years
TEAEs
Group
Value
95% CI
Clazakizumab
89
Placebo
88
Serious TEAEs
Group
Value
95% CI
Clazakizumab
39
Placebo
39
AESIs
Group
Value
95% CI
Clazakizumab
56
Placebo
52
Percentage of Participants With TEAEs, Serious TEAEs, and AESIsPrimary· Up to 4 years
TEAEs
Group
Value
95% CI
Clazakizumab
95.7
Placebo
88.0
Serious TEAEs
Group
Value
95% CI
Clazakizumab
41.9
Placebo
39.0
AESIs
Group
Value
95% CI
Clazakizumab
60.2
Placebo
52.0
Number of Participants Who Tested Positive for Polyoma BK Virus (BKV), Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV)Primary· From baseline up to 4 years
Number of participants who tested positive for BKV, CMV or EBV according to the maximum measured viral amount (International Units/mL \[IU/mL\]) after baseline are reported here.
BKV >Lower limit of quantification (LLOQ) to <320 IU/mL
Group
Value
95% CI
Clazakizumab
3
Placebo
2
BKV >=320 IU/mL to <3200 IU/mL
Group
Value
95% CI
Clazakizumab
1
Placebo
0
BKV >=3200 IU/mL
Group
Value
95% CI
Clazakizumab
1
Placebo
0
CMV >LLOQ to <1000 IU/mL
Group
Value
95% CI
Clazakizumab
5
Placebo
1
CMV >=1000 IU/mL to <5000 IU/mL
Group
Value
95% CI
Clazakizumab
2
Placebo
2
CMV >=5000 IU/mL
Group
Value
95% CI
Clazakizumab
0
Placebo
0
EBV >LLOQ to <10200 IU/mL
Group
Value
95% CI
Clazakizumab
8
Placebo
7
EBV >=10200 IU/mL to <20400 IU/mL
Group
Value
95% CI
Clazakizumab
0
Placebo
0
Number of Participants With Abnormal Laboratory Test ResultsPrimary· Up to 4 years
Laboratory tests included liver function test (LFTs), complete blood count (CBC), plasma lipids, high-sensitivity C-reactive protein (hsCRP). Only participants with abnormal laboratory test results are reported here. Here, ULN = upper limit of normal, LLN = lower limit of normal, ALT = Alanine aminotransferase and AST = Aspartate aminotransferase.
ALT : >ULN to 3 x ULN
Group
Value
95% CI
Clazakizumab
15
Placebo
6
ALT : > 3 to 5 × ULN
Group
Value
95% CI
Clazakizumab
0
Placebo
1
AST : >ULN to 3 x ULN
Group
Value
95% CI
Clazakizumab
11
Placebo
4
AST : > 3 to 5 × ULN
Group
Value
95% CI
Clazakizumab
1
Placebo
0
AST : > 5 × ULN
Group
Value
95% CI
Clazakizumab
0
Placebo
2
Bilirubin: > ULN to 2 × ULN
Group
Value
95% CI
Clazakizumab
20
Placebo
6
Bilirubin: > 2 × ULN
Group
Value
95% CI
Clazakizumab
5
Placebo
0
Neutrophils: < 2.5 to 1.5 10^9/L
Group
Value
95% CI
Clazakizumab
33
Placebo
21
Percentage of Participants With Abnormal Laboratory Test ResultsPrimary· Up to 4 years
Laboratory tests included LFTs, CBC, plasma lipids, hsCRP. Only percentage of participants with abnormal laboratory test results are reported here. Here, ULN = upper limit of normal, LLN = lower limit of normal, ALT = Alanine aminotransferase and AST = Aspartate aminotransferase.
ALT : >ULN to 3 x ULN
Group
Value
95% CI
Clazakizumab
16.1
Placebo
6.1
ALT : > 3 to 5 × ULN
Group
Value
95% CI
Clazakizumab
0
Placebo
1.0
AST : >ULN to 3 x ULN
Group
Value
95% CI
Clazakizumab
11.8
Placebo
4.0
AST : > 3 to 5 × ULN
Group
Value
95% CI
Clazakizumab
1.1
Placebo
0
AST : > 5 × ULN
Group
Value
95% CI
Clazakizumab
0
Placebo
2.0
Bilirubin: > ULN to 2 × ULN
Group
Value
95% CI
Clazakizumab
21.5
Placebo
6.1
Bilirubin: > 2 × ULN
Group
Value
95% CI
Clazakizumab
5.4
Placebo
0
Neutrophils: < 2.5 to 1.5 10^9/L
Group
Value
95% CI
Clazakizumab
35.5
Placebo
21.2
Number of Participants With Clinically Significant Change in Vital Signs, Electrocardiograms (ECGs), and Physical ExaminationPrimary· Up to 4 years
Group
Value
95% CI
Clazakizumab
0
Placebo
0
Number of Participants With Positive Anti-drug AntibodiesPrimary· Baseline, Weeks 12, 24, and 48
Baseline
Group
Value
95% CI
Clazakizumab
5
Placebo
10
Week 12
Group
Value
95% CI
Clazakizumab
3
Placebo
8
Week 24
Group
Value
95% CI
Clazakizumab
2
Placebo
7
Week 48
Group
Value
95% CI
Clazakizumab
0
Placebo
4
Percentage of Participants With Positive Anti-drug AntibodiesPrimary· Baseline, Weeks 12, 24, and 48
Baseline
Group
Value
95% CI
Clazakizumab
5.7
Placebo
10.3
Week 12
Group
Value
95% CI
Clazakizumab
4.1
Placebo
9.8
Week 24
Group
Value
95% CI
Clazakizumab
2.9
Placebo
9.7
Week 48
Group
Value
95% CI
Clazakizumab
0
Placebo
7.7
Number of Participants With Composite All-cause Allograft LossSecondary· From Baseline to 4 years
Composite all-cause allograft loss, defined as, time to first occurrence of any of the following components:
* eGFR \< 15 mL/min/1.73 m\^2\*
* return to dialysis\*
* allograft nephrectomy
* retransplantation, or
* death from any cause.
(\*Total cumulative duration of sustained eGFR \< 15 mL/min/1.73 m\^2 AND / OR dialysis \>= 60 days.) If the eGFR \< 15 mL/min/1.73 m\^2 was the only component reached, the value must be sustained over at least 60 days and must be confirmed by a repeat measurement after \>= 60 days from the first measurement. The number of participants with composite all-cause
Group
Value
95% CI
Clazakizumab
17
Placebo
14
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 4 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This trial investigates the efficacy and safety of clazakizumab \[an anti-interleukin (IL)-6 monoclonal antibody (mAb)\] for the treatment of CABMR in recipients of a kidney transplant.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04381052 — Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection
· Phase 2
· terminated
NCT04348500 — Clazakizumab (Anti-Interleukin 6 (IL-6) Monoclonal) Compared to Placebo for Coronavirus Disease 2019 (COVID-19)
· Phase 2
· completed
NCT04129931 — PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study
· Phase 2
· completed
NCT03380962 — Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant
· Phase 1, PHASE2
· active not recruiting
Other recruiting trials for Antibody-mediated Rejection
Currently open trials in the same condition.
NCT06685757 — A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have A
· Phase 3
· recruiting
NCT06112951 — A Prospective Randomized Trial of ECP in Subclinical AMR
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· recruiting
NCT05004493 — Biorepository and Registry for Plasma Exchange Patients
· recruiting
NCT05184426 — MuLtimodality EvaluatiOn of aNtibody mEdiated Damage in Heart Transplantation (LEONE-HT)
· active not recruiting
NCT03380962 — Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant
· Phase 1, PHASE2
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by CSL Behring
Last refreshed: 23 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03744910.