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Article: Belatacept: the challenges with transformational drugs.

Vincenti, Flavio

2017 Volume 6, Issue 2, Page(s) 341–342

Language	English
Publishing date	2017-05-01
Publishing country	China
Document type	Journal Article ; Comment
ZDB-ID	2851630-8
ISSN	2223-4691 ; 2223-4691 ; 2223-4683
ISSN (online)	2223-4691
ISSN	2223-4691 ; 2223-4683
DOI	10.21037/tau.2017.03.07
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: State of the art in childhood nephrotic syndrome: concrete discoveries and unmet needs.

Vincenti, Flavio / Angeletti, Andrea / Ghiggeri, Gian Marco

Frontiers in immunology

2023 Volume 14, Page(s) 1167741

Abstract: Nephrotic syndrome (NS) is a clinical entity characterized by proteinuria, hypoalbuminemia, and peripheral edema. NS affects about 2-7 per 100,000 children aged below 18 years old yearly and is classified, based on the response to drugs, into steroid ... ...

Abstract	Nephrotic syndrome (NS) is a clinical entity characterized by proteinuria, hypoalbuminemia, and peripheral edema. NS affects about 2-7 per 100,000 children aged below 18 years old yearly and is classified, based on the response to drugs, into steroid sensitive (SSNS), steroid dependent, (SDNS), multidrug dependent (MDNS), and multidrug resistant (MRNS). Forms of NS that are more difficult to treat are associated with a worse outcome with respect to renal function. In particular, MRNS commonly progresses to end stage renal failure requiring renal transplantation, with recurrence of the original disease in half of the cases. Histological presentations of NS may vary from minimal glomerular lesions (MCD) to focal segmental glomerulosclerosis (FSGS) and, of relevance, the histological patterns do not correlate with the response to treatments. Moreover, around half of MRNS cases are secondary to causative pathogenic variants in genes involved in maintaining the glomerular structure. The pathogenesis of NS is still poorly understood and therapeutic approaches are mostly based on clinical experience. Understanding of pathogenetic mechanisms of NS is one of the 'unmet needs' in nephrology and represents a significant challenge for the scientific community. The scope of the present review includes exploring relevant findings, identifying unmet needs, and reviewing therapeutic developments that characterize NS in the last decades. The main aim is to provide a basis for new perspectives and mechanistic studies in NS.
MeSH term(s)	Child ; Humans ; Adolescent ; Nephrotic Syndrome/drug therapy ; Kidney Glomerulus/pathology ; Proteinuria/pathology ; Glomerulosclerosis, Focal Segmental/pathology ; Steroids/therapeutic use
Chemical Substances	Steroids
Language	English
Publishing date	2023-07-12
Publishing country	Switzerland
Document type	Journal Article ; Review ; Research Support, Non-U.S. Gov't
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2023.1167741
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Article ; Online: Belatacept and Long-Term Outcomes in Kidney Transplantation.

Vincenti, Flavio

The New England journal of medicine

2016 Volume 374, Issue 26, Page(s) 2600–2601

MeSH term(s)	Abatacept/administration & dosage ; Cyclosporine/therapeutic use ; Graft Survival ; Humans ; Immunosuppressive Agents/administration & dosage ; Kidney Failure, Chronic/surgery ; Kidney Transplantation
Chemical Substances	Immunosuppressive Agents ; Abatacept (7D0YB67S97) ; Cyclosporine (83HN0GTJ6D)
Language	English
Publishing date	2016-06-30
Publishing country	United States
Document type	Comment ; Letter
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc1602859
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Article ; Online: Burden of neutropenia and leukopenia among adult kidney transplant recipients: A systematic literature review of observational studies.

Raval, Amit D / Kistler, Kristin D / Tang, Yuexin / Vincenti, Flavio

Transplant infectious disease : an official journal of the Transplantation Society

2023 Volume 25, Issue 1, Page(s) e14000

Abstract: Background: Leukopenia and neutropenia (L/N) may affect treatment decisions, potentially resulting in poor clinical and economic outcomes among kidney transplant recipients (KTRs). The burden of L/N is poorly quantified systematically. This systematic ... ...

Abstract	Background: Leukopenia and neutropenia (L/N) may affect treatment decisions, potentially resulting in poor clinical and economic outcomes among kidney transplant recipients (KTRs). The burden of L/N is poorly quantified systematically. This systematic literature review aimed to summarize the incidence of, risk factors for, and clinical and economic outcomes associated with L/N post-KT. Methods: We systematically searched MEDLINE, Embase, and the Cochrane Library (from database inception-June 14, 2021) and conferences (past 3 years) to identify observational studies examining epidemiology, risk factors, or outcomes associated with L/N among adult KTRs. Results: Of 2081 records, 82 studies met inclusion criteria. Seventy-three studies reported the epidemiology of L/N post-KT. Pooled incidence of neutropenia, defined as absolute neutrophil counts (ANC) <1000/μl, ranged from 13% to 48% within 1-year post-transplant; ANC <500/μl ranged from 15% to 20%. Leukopenia, defined as white blood cell counts <3500/μl, was 19% to 83%. Eleven studies reported independent risk factors associated with L/N post-KT. D+/R- cytomegalovirus status, mycophenolic acid (MPA), and tacrolimus use were the most consistent risk factors across studies. Fourteen studies reported L/N-associated clinical outcomes. We noted a trend toward a positive association between neutropenia and acute rejection/opportunistic infections. Mixed findings were noted on the association between L/N and graft failure or mortality. Dosage modifications of valganciclovir, MPA, cotrimoxazole, and anti-thymoglobulin and the need for granulocyte colony-stimulating factor (G-CSF) use were common with L/N. Conclusion: Findings suggest post-transplant L/N were common and associated with frequent modifications of immunosuppressive agents, requiring G-CSF use, and rejection or opportunistic infections. Findings highlight the need for interventions to reduce risk of L/N post-KT.
MeSH term(s)	Humans ; Adult ; Kidney Transplantation/adverse effects ; Neutropenia/chemically induced ; Leukopenia/etiology ; Valganciclovir/therapeutic use ; Immunosuppressive Agents/therapeutic use ; Granulocyte Colony-Stimulating Factor/therapeutic use ; Mycophenolic Acid/therapeutic use ; Anemia/etiology ; Opportunistic Infections/drug therapy ; Transplant Recipients ; Graft Rejection/epidemiology
Chemical Substances	Valganciclovir (GCU97FKN3R) ; Immunosuppressive Agents ; Granulocyte Colony-Stimulating Factor (143011-72-7) ; Mycophenolic Acid (HU9DX48N0T)
Language	English
Publishing date	2023-01-19
Publishing country	Denmark
Document type	Systematic Review ; Journal Article
ZDB-ID	1476094-0
ISSN	1399-3062 ; 1398-2273
ISSN (online)	1399-3062
ISSN	1398-2273
DOI	10.1111/tid.14000
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Article ; Online: Open letter to Bristol Myers Squibb: Belatacept; we aren't done yet.

Vincenti, Flavio / Budde, Klemens / Grinyo, Josep / Rostaing, Lionel / Kirk, Allan D / Larsen, Christian P

American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons

2023 Volume 23, Issue 10, Page(s) 1483–1484

MeSH term(s)	Abatacept/therapeutic use ; Immunosuppressive Agents/therapeutic use ; Kidney Transplantation
Chemical Substances	Abatacept (7D0YB67S97) ; Immunosuppressive Agents
Language	English
Publishing date	2023-06-09
Publishing country	United States
Document type	Editorial
ZDB-ID	2060594-8
ISSN	1600-6143 ; 1600-6135
ISSN (online)	1600-6143
ISSN	1600-6135
DOI	10.1016/j.ajt.2023.05.033
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Zs.A 5542: Show issues

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Article ; Online: The hepatocyte growth factor mimetic, ANG-3777, in kidney transplant recipients with delayed graft function: Results from a randomized phase 3 trial.

Vincenti, Flavio / Bromberg, Jonathan / Kim, Jim / Faravardeh, Arman / Leca, Nicolae / Alperovich, Gabriela / Csomor, Philipp Andreas / Aslam, Shakil / Neylan, John

American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons

2024

Abstract: In kidney transplant recipients, delayed graft function increases the risk of graft failure and mortality. In a phase 3, randomized, double-blind, placebo-controlled trial, we investigated the hepatocyte growth factor mimetic, ANG-3777 (once daily for 3 ... ...

Abstract	In kidney transplant recipients, delayed graft function increases the risk of graft failure and mortality. In a phase 3, randomized, double-blind, placebo-controlled trial, we investigated the hepatocyte growth factor mimetic, ANG-3777 (once daily for 3 consecutive days, starting ≤30 hours posttransplant), in 248 patients receiving a first kidney transplant from a deceased donor. At day 360, estimated glomerular filtration rate (primary endpoint) was not significantly different between the ANG-3777 and placebo groups. There were no significant between-group differences in the duration of dialysis through day 30 or in the percentage of patients with an estimated glomerular filtration rate of >30 mL/min/1.73 m
Language	English
Publishing date	2024-02-20
Publishing country	United States
Document type	Journal Article
ZDB-ID	2060594-8
ISSN	1600-6143 ; 1600-6135
ISSN (online)	1600-6143
ISSN	1600-6135
DOI	10.1016/j.ajt.2024.02.014
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Book ; Online: Nonlinear Model Predictive Control for Quadrupedal Locomotion Using Second-Order Sensitivity Analysis

Kang, Dongho / De Vincenti, Flavio / Coros, Stelian

2022

Abstract: We present a versatile nonlinear model predictive control (NMPC) formulation for quadrupedal locomotion. Our formulation jointly optimizes a base trajectory and a set of footholds over a finite time horizon based on simplified dynamics models. We ... ...

Abstract	We present a versatile nonlinear model predictive control (NMPC) formulation for quadrupedal locomotion. Our formulation jointly optimizes a base trajectory and a set of footholds over a finite time horizon based on simplified dynamics models. We leverage second-order sensitivity analysis and a sparse Gauss-Newton (SGN) method to solve the resulting optimal control problems. We further describe our ongoing effort to verify our approach through simulation and hardware experiments. Finally, we extend our locomotion framework to deal with challenging tasks that comprise gap crossing, movement on stepping stones, and multi-robot control. Comment: 5 pages. 5 figures. Presented in ICRA 2022: 6th Full-Day Workshop on Legged Robots. The first two authors contributed equally to this work. The supplementary video is available in https://youtu.be/BrJSRlAJaX4
Keywords	Computer Science - Robotics
Publishing date	2022-07-21
Publishing country	us
Document type	Book ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Are calcineurin inhibitors-free regimens ready for prime time?

Vincenti, Flavio

Kidney international

2012 Volume 82, Issue 10, Page(s) 1054–1060

Abstract: The goal of research in transplant therapeutics is to achieve safe and effective immunosuppression strategies that allow durable engraftment free of toxicities. The calcineurin inhibitors (CNIs) regimens, because of their inherent toxicities (including ... ...

Abstract	The goal of research in transplant therapeutics is to achieve safe and effective immunosuppression strategies that allow durable engraftment free of toxicities. The calcineurin inhibitors (CNIs) regimens, because of their inherent toxicities (including nephrotoxicity), have been unable to meet these promises. Over the past decade acute cellular rejection decreased dramatically with a concomitant robust increase in 1-year graft survival; however, long-term graft outcome showed only modest improvement. This is due in part to the toxicities of the immunosuppressive drugs. The quest for a toxicity-free-CNI-free regimen has been both intense and frustrating. A turning point in CNIs-free therapy may have occurred with the recent approval of belatacept, which represents a new paradigm in immunosuppression: biological therapy for chronic immunosuppression devoid of the usual toxicities associated with the CNIs. Belatacept, a fusion receptor protein, blocks costimulation signals necessary for the activation of T cells. Although costimulation blockade has not been shown to induce tolerance, it can provide safe and effective immunosuppression without renal or cardiovascular toxicities. The approval of belatacept in both the United States and Europe for use in renal transplantation will finally push CNI-free regimens into prime time. Novel biologics such as ASKP1240 (a human anti-CD40 monoclonal antibody) and one small molecule, tofacitinib, may advance further the use of CNI-free regimens in organ transplantation.
MeSH term(s)	Abatacept ; Calcineurin Inhibitors ; Drug Therapy, Combination ; Graft Rejection/immunology ; Graft Rejection/prevention & control ; Graft Survival/drug effects ; Humans ; Immunoconjugates/therapeutic use ; Immunosuppressive Agents/adverse effects ; Immunosuppressive Agents/therapeutic use ; Kidney Diseases/chemically induced ; Piperidines/therapeutic use ; Pyrimidines/therapeutic use ; Pyrroles/therapeutic use ; Time Factors ; Treatment Outcome
Chemical Substances	Calcineurin Inhibitors ; Immunoconjugates ; Immunosuppressive Agents ; Piperidines ; Pyrimidines ; Pyrroles ; Abatacept (7D0YB67S97) ; tofacitinib (87LA6FU830)
Language	English
Publishing date	2012-11
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	120573-0
ISSN	1523-1755 ; 0085-2538
ISSN (online)	1523-1755
ISSN	0085-2538
DOI	10.1038/ki.2012.194
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Article ; Online: Outcomes among CMV-mismatched and highly sensitized kidney transplants recipients who develop neutropenia.

Brar, Sandeep / Berry, Reyoot / Raval, Amit D / Tang, Yuexin / Vincenti, Flavio / Skartsis, Nikolaos

Clinical transplantation

2022 Volume 36, Issue 4, Page(s) e14583

Abstract: Limited data exist on the incidence and clinical outcomes of neutropenia among kidney transplant recipients. Our study included 572 adults who received a kidney transplant at the University of California, San Francisco Medical Center between 2012 and ... ...

Abstract	Limited data exist on the incidence and clinical outcomes of neutropenia among kidney transplant recipients. Our study included 572 adults who received a kidney transplant at the University of California, San Francisco Medical Center between 2012 and 2018, and were CMV-mismatched or had a PRA ≥ 80%. Recipients with HIV, Hepatitis B and C, and primary non-function were excluded. Participants were followed for at least 1 year after transplantation. Neutropenia was defined as absolute neutrophil count < 1000 cells/μl. Cox proportional hazards regression models using neutropenia as a time-varying predictor were used to determine the risk of mycophenolic acid and valganciclovir changes, rejection, hospitalizations and use of granulocyte colony stimulating factor. Models were adjusted for demographics and transplant characteristics. Mean follow-up was 3.7 (SD, 1.8) years. The mean age of the cohort was 50.4 (13.1) years, and 57.5% were female. A total of 208 (36.3%) participants had neutropenia. Neutropenia was associated with an increased risk of valganciclovir or MPA dose reductions or discontinuations [adjusted hazard ratio, aHR: 7.78, 95% CI: 4.73-12.81], rejection [aHR 2.00, 95% CI: 1.10-3.64] and hospitalizations [aHR 3.32, 95% CI: 2.12-5.19]. Neutropenia occurs frequently after kidney transplantation and leads to more medication changes and adverse clinical outcomes.
MeSH term(s)	Adult ; Cytomegalovirus Infections/complications ; Cytomegalovirus Infections/etiology ; Female ; Graft Rejection/drug therapy ; Graft Rejection/etiology ; Humans ; Kidney Transplantation/adverse effects ; Middle Aged ; Neutropenia/drug therapy ; Neutropenia/etiology ; Retrospective Studies ; Transplant Recipients ; Valganciclovir/therapeutic use
Chemical Substances	Valganciclovir (GCU97FKN3R)
Language	English
Publishing date	2022-01-15
Publishing country	Denmark
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	639001-8
ISSN	1399-0012 ; 0902-0063
ISSN (online)	1399-0012
ISSN	0902-0063
DOI	10.1111/ctr.14583
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Article ; Online: Transplant trials with Tregs: perils and promises.

Tang, Qizhi / Vincenti, Flavio

The Journal of clinical investigation

2017 Volume 127, Issue 7, Page(s) 2505–2512

Abstract: Modern immunosuppression regimens effectively control acute rejection and decrease graft loss in the first year after transplantation; however, these regimens do not have a durable effect on long-term graft survival owing to a combination of drug ... ...

Abstract	Modern immunosuppression regimens effectively control acute rejection and decrease graft loss in the first year after transplantation; however, these regimens do not have a durable effect on long-term graft survival owing to a combination of drug toxicities and the emergence of chronic alloimmune responses. Eliminating drugs and their toxicities while maintaining graft acceptance has been the primary aim of cellular therapies. Tregs suppress both autoimmune and alloimmune responses and are particularly effective in protecting allografts in experimental transplant models. Further, Treg-based therapies are selective, do not require harsh conditioning, and do not have a risk of graft-versus-host disease. Trial designs should consider the distinct immunological features of each transplanted organ, Treg preparations, dose, and frequency, and the ability to detect and quantify Treg effects in a given transplant environment. In this Review, we detail the ongoing clinical trials of Treg therapy in liver and kidney transplantation. Integration of Treg biology gleaned from preclinical models and experiences in human organ transplantation should allow for optimization of trial design that will determine the potential efficacy of a given therapy and provide guidelines for further therapeutic development.
MeSH term(s)	Clinical Trials as Topic ; Graft Rejection/immunology ; Graft Rejection/therapy ; Humans ; Kidney Transplantation ; Liver Transplantation ; T-Lymphocytes, Regulatory/immunology ; T-Lymphocytes, Regulatory/transplantation
Language	English
Publishing date	2017-06-30
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	3067-3
ISSN	1558-8238 ; 0021-9738
ISSN (online)	1558-8238
ISSN	0021-9738
DOI	10.1172/JCI90598
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