Adults 15 to 75, any sex, with Antibody-mediated Rejection or Kidney Transplant; Complications. 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.
Number of Participants With Donor Specific Antibody (DSA) Elimination or Reduction Based on Luminex HLA TestingPrimary· 12 months
Did clazakizumab eliminate or weaken donor specific antibody (DSA) mean fluorescence intensity (MFI) intensities? HLA antibodies were detected by the single antigen bead-based assay (One lambda, Los Angeles, CA). Donor HLA-specific antibodies were assessed throughout clazakizumab treatment for the first year. Detection of DSAs were only reported with MFI \>2500.
Group
Value
95% CI
Clazakizumab (Anti-IL-6 Monoclonal)
7
Number of Participants With Stabilization of Clinical Features of cABMR Via BANFF Biopsy Grading Criteria.Primary· 6 months
Does clazakizumab help stabilize pathologic features of antibody mediated rejection at 6 month protocol biopsies? Protocol kidney allograft biopsies were performed at 6 months and compared to the baseline biopsy which was assessed for study inclusion. Biopsy specimens were analyzed according to Banff 2017 classification.
Group
Value
95% CI
Clazakizumab (Anti-IL-6 Monoclonal)
9
Stabilization in Estimated Glomerular Filtration Rate (eGFR)Secondary· 12 months
Serum creatinine (mg/dl) collected to calculate eGFR
Group
Value
95% CI
Clazakizumab (Anti-IL-6 Monoclonal)
41.6
± 14.2
Incidence of Treatment-related Adverse EventsSecondary· 12 months
Adverse event monitoring in our patient population; did patients have treatment related adverse events and if so, how many events
Group
Value
95% CI
Clazakizumab (Anti-IL-6 Monoclonal)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
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
NCT03744910 — Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients
· Phase 3
· terminated
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
· NA
· 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
Other Stanley Jordan, MD trials
Trials by the same sponsor.
NCT03380962 — Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant
· Phase 1, PHASE2
· active not recruiting
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 Stanley Jordan, MD
Last refreshed: 6 May 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/NCT03380377.