NCT03380962CompletedPhase 1/2
Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant
A Phase I/II Trial to Evaluate the Safety and Tolerability of Clazakizumab (Anti-IL-6 Monoclonal) to Eliminate Donor Specific HLA Antibodies (DSAs) and Improve Transplant Rates in Highly-HLA Sensitized Patients Awaiting Renal Transplant
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
Patients who have had a previous allograft failure represent a major problem for transplant centers as they are highly-human leukocyte antigen (HLA) sensitized and unlikely to receive another transplant without significant desensitization. This single center, phase I/II, open label single-arm exploratory study focuses on enrolling twenty patients (ages 15-75) who will begin desensitization therapy to achieve HLA incompatible (HLAi) renal transplantation. Patients who qualify will receive up to 6 doses of clazakizumab 25 mg monthly pre-transplantation. If patients receive an HLAi transplant during the study, the participants will continue to receive another 6 monthly doses of clazakizumab 25 mg, followed by a 6 month protocol biopsy. Patients will continue another 6 doses over 6 months if improvements are seen after the 6th dose of clazakizumab. Patients who develop evidence of persistent allograft dysfunction may have non-protocol biopsies for cause. Patients who receive 12 doses of clazakizumab post-transplant will receive a 12M protocol biopsy.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 30 Oct 2017
- Start date
- 27 Feb 2018
- Primary completion date
- 30 Aug 2025
- Lead sponsor
- Stanley Jordan, MD
- Diseases
- Chronic kidney disease
- NCT number
- NCT03380962
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 20
- From 27 Feb 2018 to the primary completion date, 30 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Multi-organ transplant (e.g. kidney and pancreas)
- Intolerability to clazakizumab or other interleukin-6 (IL-6) inhibitor therapies
- Recent recipients of any licensed or investigational live attenuated vaccine(s) within two months of the screening visit
- Use of investigational agents within 4 weeks of participation.
- 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
Other illness
- HIV-positive subjects.
- Subjects who test positive for hepatitis B virus (HBV) by HBVeAg/DNA or hepatitis C virus (HCV) infection \[positive Anti-HCV (EIA) and confirmatory HCV RIBA\].
- Subjects with latent or active tuberculosis. Subjects must have negative Quantiferon TB gold test result.
- Subjects with active Cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection as defined by CMV-specific serology (IgG or IgM) and confirmed by quantitative PCR with or without a compatible illness.
- 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).
Lab values
- A significantly abnormal general serum screening lab result defined as a absolute neutrophil count (ANC) \<2000, platelet count \< 100 X 10\^3/ml, an aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 1.5X upper limit normal.
Age
- Women of child-bearing age and male partners of women of child-bearing age who are not willing or able to practice FDA-approved forms of contraception during study and for 5 months after last dose.
Other
- Lactating or pregnant females.
- Individuals deemed unable to comply with the protocol.
Who the study is looking for
- Age 15-75 years at the time of screening.
- HS patients (cPRA≥50%) awaiting deceased donor (DD) or living donor (LD) kidney transplant on the UNOS list.
- Previous history of pregnancies, blood transfusion and/or renal transplant.
- Subject/Parent/Guardian must be willing to participate fully with study requirements.
- Subject/Parent/Guardian must be able to understand and provide informed consent.
- Pneumococcal vaccinated
- Negative Tuberculin (ppd) placement result or negative Quantiferon tuberculosis (TB) gold results
Age in the registry: 15 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Norko Ammerman Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.