Phase 2
N=10
Clazakizumab for Chronic and Active Antibody Mediated Rejection Post-Kidney Transplant
Antibody-mediated Rejection · Kidney Transplant; Complications · Transplant Glomerulopathy · Transplant Glomerulopathy - Late Form · Transplant Glomerulopathy - Early Form
Bottom Line
View on ClinicalTrials.gov: NCT03380377 ↗Enrolled (actual)
10
Serious AEs
20.0%
Results posted
May 2025
Primary outcome: Primary: Number of Participants With Donor Specific Antibody (DSA) Elimination or Reduction Based on Luminex HLA Testing — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Clazakizumab (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Stanley Jordan, MD
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Donor Specific Antibody (DSA) Elimination or Reduction Based on Luminex HLA Testing |
7 | — |
| PRIMARY Number of Participants With Stabilization of Clinical Features of cABMR Via BANFF Biopsy Grading Criteria. |
9 | — |
| SECONDARY Stabilization in Estimated Glomerular Filtration Rate (eGFR) |
41.6 | — |
| SECONDARY Incidence of Treatment-related Adverse Events |
— | — |
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.
Eligibility Criteria
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)
- eGFR 3X upper limit normal
- Individuals deemed unable to comply with the protocol.
- Subjects with active CMV or EBV infection as defined by CMV-specific serology (IgG or IgM) and confirmed by quantitative PCR with or without a compatible illness.
- Use of investigational agents within 4 weeks of participation.
- History or active Inflammatory Bowel Disease or Diverticular Disease or gastrointestinal perforation
- Recent infection (within past 6 weeks of screening) requiring any antibiotic use (oral, parenteral or topical).
- Present or previous (within 5 years) malignancy except for basal cell carcinoma, fully excised squamous cell carcinoma of the skin or non-recurrent (within 5 years) cervical carcinoma-in-situ.
Data sourced from ClinicalTrials.gov (NCT03380377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.