ArticleTrials2022
Clazakizumab for the treatment of chronic active antibody-mediated rejection (AMR) in kidney transplant recipients: Phase 3 IMAGINE study rationale and design.
Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03744910 (A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for the Treatment of Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients), which is not on this map. Cited by 24 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for the Treatment of Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients
Who cites it
24 citing papers in PubMed, 37 citations in OpenAlex.
- Iron, ESA, and HIF-Inhibitors: Are There Other Opportunities to Improve Anemia of CKD?Journal of clinical medicine · 2026Review
- Therapeutic Applications of Immunobiologics in Autoimmune and Inflammatory Diseases.Pharmaceutics · 2026Review
- Profiling Localized Immunomodulation and Drug Biodistribution within a Subcutaneous Vascularized Niche for Cell Transplantation.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Treatment of antibody-mediated rejection in heart transplantation: from empirical combination to multi-target precision intervention.Frontiers in immunology · 2026Review
- Anti-CD38 Daratumumab Treatment of Chronic Active Antibody-Mediated Kidney Allograft Rejection.Kidney international reports · 2025Article
- Review
- Review
- Targeting IL-6 in antibody-mediated kidney transplant rejection.Clinical kidney journal · 2025Review
- Chronic Allograft Nephropathy-A Narrative Review of Its Pathogenesis, Diagnosis, and Evolving Management Strategies.Biomedicines · 2025Review
- Ziltivekimab for anemia and atherosclerosis in chronic kidney disease: a new hope?Journal of nephrology · 2025Review
- New Immunosuppressants in Pediatric Kidney Transplantation: What's in the Pipeline for Kids?Pediatric transplantation · 2025Review
- Biomarker integration and biosensor technologies enabling AI-driven insights into biological aging.Frontiers in aging · 2025Review
- Tocilizumab-Based Treatment of Microvascular Inflammation in Kidney Transplant Recipients: A Retrospective Study.Transplant international : official journal of the European Society for Organ Transplantation · 2025Article
- Granulomatous Tubulointerstitial Nephritis in a Kidney Allograft: Treatment with Interleukin-6 Receptor Antagonist Stabilises Kidney Function.Journal of clinical medicine · 2024Review
- New treatment for antibody-mediated rejection: interleukin-6 inhibitors.Clinical transplantation and research · 2024Review
- Article
- Deciphering the Complexity of the Immune Cell Landscape in Kidney Allograft Rejection.Transplant international : official journal of the European Society for Organ Transplantation · 2024Review
- Transplant Trial Watch.Transplant international : official journal of the European Society for Organ Transplantation · 2024Article
- Pretransplant, Th17 dominant alloreactivity in highly sensitized kidney transplant candidates.Frontiers in transplantation · 2024Article
- De Novo Donor-Specific Antibodies after Heart Transplantation: A Comprehensive Guide for Clinicians.Journal of clinical medicine · 2023Review
Corrections and comments
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Authors and funding
10 authors at 8 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundChronic active antibody-mediated rejection (AMR) is a major cause of graft loss with no approved drugs for its treatment. Currently, off-label regimens are used, reflecting the high unmet need for effective therapies based on well-controlled trials. Clazakizumab is a high-affinity, humanized monoclonal antibody that binds interleukin-6 and decreases donor-specific antibody (DSA) production and inflammation. Phase 2 pilot studies of clazakizumab in kidney transplant recipients with chronic active AMR suggest modulation of DSA, stabilization of glomerular filtration rate (GFR), and a manageable safety profile. We report the design of the Phase 3 IMAGINE study (NCT03744910) to evaluate the safety and efficacy of clazakizumab for the treatment of chronic active AMR.
methodsIMAGINE is a multicenter, double-blind trial of approximately 350 kidney transplant recipients with chronic active AMR (Banff chronic glomerulopathy [cg] >0 with concurrent positive human leukocyte antigen DSA) randomized 1:1 to receive clazakizumab or placebo (12.5 mg subcutaneous once every 4 weeks). The event-driven trial design will follow patients until 221 occurrences of all-cause graft loss are observed, defined as return to dialysis, graft nephrectomy, re-transplantation, estimated GFR (eGFR) <15 mL/min/1.73m DISCUSSION: IMAGINE represents the first Phase 3 clinical trial investigating the safety and efficacy of clazakizumab in kidney transplant recipients with chronic active AMR, and the largest placebo-controlled trial in this patient population. This trial includes prognostic biomarker enrichment and uniquely utilizes the eGFR slope at 1 year as a surrogate endpoint for graft loss, which may accelerate the approval of a novel therapy for patients at risk of graft loss. The findings of this study will be fundamental in helping to address the unmet need for novel therapies for chronic active AMR.
trial registrationClinicalTrials.gov NCT03744910 . Registered on November 19, 2018.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.