Trial reportTransplantation2021
Imlifidase Desensitization in Crossmatch-positive, Highly Sensitized Kidney Transplant Recipients: Results of an International Phase 2 Trial (Highdes).
Trial report in Transplantation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
51 citing papers in PubMed, 109 citations in OpenAlex.
- Five Years Follow-up of Imlifidase Desensitized Kidney Transplant Recipients.Transplant international : official journal of the European Society for Organ Transplantation · 2025Trial
- Immunoadsorption-Based HLA Desensitization in Patients Awaiting Deceased Donor Kidney Transplantation: An Interventional, Non-Randomised, Single Cohort Study.Transplant international : official journal of the European Society for Organ Transplantation · 2023Trial
- Outcomes at 3 years posttransplant in imlifidase-desensitized kidney transplant patients.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2021Trial
- AI-enabled clinical trials.Nature reviews bioengineering · 2026Article
- Molecular Diagnosis of Early Equivocal Alloimmune Injury After Imlifidase Desensitization in a Kidney Transplant Recipient.Transplantation direct · 2026Article
- Clinical implications of imlifidase interference in antibody screening and transfusion management.Transfusion · 2026Article
- Safety of Adeno-Associated Viral Vectors in Gene Therapy: Mechanisms of Toxicity, Clinical Risks, and Strategies for Their Minimization.International journal of molecular sciences · 2026Review
- Polypharmacology of S-1117, an Fc-fused IgG-selective degrading enzyme, for chronic treatment of autoantibody-mediated diseases.Proceedings of the National Academy of Sciences of the United States of America · 2026Article
- Humoral rejection in heart transplantation in the current era.JHLT open · 2026Article
- Highly sensitized kidney transplant candidates: integrating acceptable mismatch, desensitization, imlifidase, and emerging immune-cell targeting strategies.Frontiers in immunology · 2026Review
- Article
- Risk-adapted HLA delisting and imlifidase-enabled deceased-donor kidney transplantation in highly sensitized kidney transplant candidates: a German expert consensus report.Frontiers in immunology · 2026Article
- Understanding the role of non-HLA antibodies in kidney transplantation: a literature review.Frontiers in immunology · 2026Review
- Evolving Therapeutic Approaches for Treatment of Antibody-Mediated Rejection in Renal Allograft Recipients.Results and problems in cell differentiation · 2026Review
- Long-term Graft and Patient Survival in Kidney Transplant Recipients With High Levels of Preformed DSAs (MFI > 3000): A Propensity Score-matched Analysis.Transplantation direct · 2025Article
- Therapeutic IgG- and IgM-specific proteases disarm the acetylcholine receptor autoantibodies that drive myasthenia gravis pathology.Proceedings of the National Academy of Sciences of the United States of America · 2025Article
- Desensitization With Imlifidase: Overcoming Immunological Barriers in Kidney Transplantation.Kidney medicine · 2025Article
- Desensitization in HLA-incompatible kidney transplant recipients: current strategies and emerging perspectives.Clinical kidney journal · 2025Review
- IdeZ protease does not prevent convertase stabilization by C3 nephritic factors in C3 glomerulopathy.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025Article
- Functional and phenotypic profiles of HLA-specific antibodies in relation to antibody-mediated kidney transplant rejection.Human immunology · 2025Article
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Authors and funding
16 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHighly HLA sensitized patients have limited access to life-saving kidney transplantation because of a paucity of immunologically suitable donors. Imlifidase is a cysteine protease that cleaves IgG leading to a rapid decrease in antibody level and inhibition of IgG-mediated injury. This study investigates the efficacy and safety of imlifidase in converting a positive crossmatch test to negative, allowing highly sensitized patients to be transplanted with a living or deceased donor kidney.
methodsThis open-label, single-arm, phase 2 trial conducted at 5 transplant centers, evaluated the ability of imlifidase to create a negative crossmatch test within 24 h. Secondary endpoints included postimlifidase donor-specific antibody levels compared with predose levels, renal function, and pharmacokinetic/pharmacodynamic profiles. Safety endpoints included adverse events and immunogenicity profile.
resultsOf the transplanted patients, 89.5% demonstrated conversion of baseline positive crossmatch to negative within 24 h after imlifidase treatment. Donor-specific antibodies most often rebounded 3-14 d postimlifidase dose, with substantial interpatient variability. Patient survival was 100% with graft survival of 88.9% at 6 mo. With this, 38.9% had early biopsy proven antibody-mediated rejection with onset 2-19 d posttransplantation. Serum IgG levels began to normalize after ~3-7 d posttransplantation. Antidrug antibody levels were consistent with previous studies. Seven adverse events in 6 patients were classified as possibly or probably related to treatment and were mild-moderate in severity.
conclusionsImlifidase was well tolerated, converted positive crossmatches to negative, and enabled patients with a median calculated panel-reactive antibody of 99.83% to undergo kidney transplantation resulting in good kidney function and graft survival at 6 mo.
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Registered trials
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.