Observational studyPloS one2017
Sequential Targeting of CD52 and TNF Allows Early Minimization Therapy in Kidney Transplantation: From a Biomarker to Targeting in a Proof-Of-Concept Trial.
Observational study in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02711202 (A Pilot, Open Single Centre, Prospective, Parallel Trail to Evaluate the Efficacy and Safety of Immunosuppressive Regimen Without Calcineurin Inhibitors and Steroids After Induction of Anti-CD52 and Anti-TNF-α Monoclonal Antibodies in Kidney Transplant Recipients), which is not on this map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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 Pilot, Open Single Centre, Prospective, Parallel Trail to Evaluate the Efficacy and Safety of Immunosuppressive Regimen Without Calcineurin Inhibitors and Steroids After Induction of Anti-CD52 and Anti-TNF-α Monoclonal Antibodies in Kidney Transplant Recipients
Who cites it
6 citing papers in PubMed, 12 citations in OpenAlex.
- Article
- Dynamic transcriptome analysis of osteal macrophages identifies a distinct subset with senescence features in experimental osteoporosis.JCI insight · 2024Article
- Polyfunctional donor-reactive T cells are associated with acute T-cell-mediated rejection of the kidney transplant.Clinical and experimental immunology · 2023Article
- Recent advances in kidney transplantation: a viewpoint from the Descartes advisory board.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2018Review
- Operational tolerance in kidney transplantation and associated biomarkers.Clinical and experimental immunology · 2017Review
- The immunological function of CD52 and its targeting in organ transplantation.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere is high medical need for safe long-term immunosuppression monotherapy in kidney transplantation. Selective targeting of post-transplant alloantigen-(re)activated effector-T cells by anti-TNF antibodies after global T cell depletion may allow safe drug minimization, however, it is unsolved what might be the best maintenance monotherapy.
methodsIn this open, prospective observational single-centre trial, 20 primary deceased donor kidney transplant recipients received 2x20 mg Alemtuzumab (d0/d1) followed by 5 mg/kg Infliximab (d2). For 14 days all patients received only tacrolimus, then they were allocated to either receive tacrolimus (TAC, n = 13) or sirolimus (SIR, n = 7) monotherapy, respectively. Protocol biopsies and extensive immune monitoring were performed and patients were followed-up for 60 months.
resultsTAC-monotherapy resulted in excellent graft survival (5yr 92%, 95%CI: 56.6-98.9) and function, normal histology, and no proteinuria. Immune monitoring revealed low intragraft inflammation (urinary IP-10) and hints for the development of operational tolerance signature in the TAC- but not SIR-group. Remarkably, the TAC-monotherapy was successful in all five presensitized (ELISPOT+) patients. However, recruitment into SIR-arm was stopped (after n = 7) because of high incidence of proteinuria and acute/chronic rejection in biopsies. No opportunistic infections occurred during follow-up.
conclusionsIn conclusion, our novel fast-track TAC-monotherapy protocol is likely to be safe and preliminary results indicated an excellent 5-year outcome, however, a full-scale study will be needed to confirm our findings.
trial registrationEudraCT Number: 2006-003110-18.
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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.