Divard G, Aubert O, Raynaud M, et al. TRANSFORM study (NCT01950819): application of the iBOX clinical trial simulation tool to project long-term kidney allograft outcome. Am J Transplant. 2020;20(Suppl 3): Abstract 223.
European Medicines Agency (2008). Guideline on clinical investigation of immunosuppressants for solid organ transplantation. Published July 24, 2008; Effective from January 2, 2009. Accessed 21 June 2020. https://www.ema.europa.eu/en/clinical-investigation-immunosuppressants-solid-organ-transplantation.
Foucher Y, Daguin P, Akl A, et al. A clinical scoring system highly predictive of long-term kidney graft survival. Kidney Int. 2010;78:1288-94.
Haas M, Loupy A, Lefaucher C, et al. The Banff 2017 Kidney Meeting Report: revised diagnostic criteria for chronic active T cell–mediated rejection, antibody-mediated rejection, and prospects for integrative endpoints for next-generation clinical trials. Am J Transplant. 2018;18:293-307.
Kaboré R, Haller MC, Harambat J, et al. Risk prediction models for graft failure in kidney transplantation: a systematic review. Nephrol Dial Transplant. 2017;32:ii68-76.
Kasiske BL, Israni AK, Snyder JJ, et al. A simple tool to predict outcomes after kidney transplant. Am J Kid Dis. 2010;56:947-60.
Loupy A, Aubert O, Orandi BJ, et al. Prediction system for risk of allograft loss in patients receiving kidney transplants: international derivation and validation study. BMJ. 2019;366:14923.
Mannon RB, Morris RE, Abecassis M, et al. Use of biomarkers to improve immunosuppressive drug development and outcomes in renal organ transplantation: A meeting report. Am J Transplant. 2020;20:1495-1502.
Meier-Kriesche HU, Schold JD, Srinivas TR, et al. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am J Transplant. 2004;4:378‐383.
Moore J, He X, Shabir S, et al. Development and evaluation of a composite risk score to predict kidney transplant failure. Am J Kid Dis. 2011;57:744-751.
Naesens M, Thaunat O. BENEFIT of belatacept: kidney transplantation moves forward. Nat Rev Nephrol. 2016;12:261-262.
National Institutes of Health (NIH) website. ClinicalTrials.gov identifier: NCT03663335. Study of efficacy, safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) of an anti-CD40 monoclonal antibody, CFZ533, in kidney transplant recipients (CIRRUS I). Updated March 12, 2020. Accessed 21 June 2020. https://www.clinicaltrials.gov/ct2/show/NCT03663335
Neuberger JM, Bechstein WO, Kuypers DRJ, et al. Practical recommendations for long-term management of modifiable risks in kidney and liver transplant recipients: a guidance report and clinical checklist by the consensus on managing modifiable risk in transplantation (COMMIT) group. Transplantation. 2017;101:S1-S56.
Prémaud A, Filloux M, Gatault P, et al. An adjustable predictive score of graft survival in kidney transplant patients and the levels of risk linked to de novo donor-specific anti-HLA antibodies. PLoS ONE. 2017;12:e0180236.
Schnitzler MA, Lentine KL, Gheroghian A, et al. Renal function following living, standard criteria deceased and expanded criteria deceased donor kidney transplantation: impact on graft failure and death. Transpl Int. 2012;25:179-191.
Shabir S, Halimi J-M, Cherukuri A, et al. Predicting 5-year risk of kidney transplant failure: a prediction instrument using data available at 1 year posttransplantation. Am J Kid Dis. 2014;63:643-651.
Stegall M, Morris Re, Alloway RR, et al. Developing new immunosuppression for the next generation of transplant recipients: the path forward. Am J Transplant. 2016;16:1094-1101.

WebMD Global requires each individual who is in a position to control the content of one of its educational activities to disclose any relevant financial relationships occurring within the past 12 months that could create a conflict of interest.

Faculty

Alexandre Loupy, MD, PhD

Professor of Nephrology
Head of Team at National Institute of Medical Research
Paris, France

Disclosures

Disclosure: Alexandre Loupy, MD, PhD, has disclosed no relevant financial relationships.

Stefan Berger, MD, PhD

Professor Head, Nephrology Department
University Medical Centre Groningen
Groningen, Netherlands

Disclosures

Disclosure: Stefan Berger, MD, PhD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: Novartis Pharmaceuticals Corporation
Served as a speaker or a member of a speakers bureau for: Novartis Pharmaceuticals Corporation
Received grants for clinical research from: Chiesi Pharmaceuticals, Inc.; Novartis Pharmaceuticals Corporation

Maarten Naesens, MD, PhD

Professor of Microbiology
Immunology, and Transplantation
KU Leuven
Nephrologist, University Hospitals Leuven
Leuven, Belgium

Disclosures

Disclosure: Maarten Naesens, MD, PhD, has disclosed no relevant financial relationships.

Editors

Marinella Calle, PhD, CMPP

Medical Education Director, WebMD Global, LLC

Disclosures

Disclosure: Marinella Calle, PhD, CMPP, has disclosed no relevant financial relationships.

Ryan Blanchard, PhD

Medical Education Director, WebMD Global, LLC

Disclosures

Disclosure: Ryan Blanchard, PhD, has disclosed no relevant financial relationships.

Content Reviewer

Robert Morris, PharmD

Associate Director, Accreditation and Compliance

Disclosures

Disclosure: Robert Morris, PharmD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: ViiV Healthcare
Owns stock, stock options, or bonds from: GlaxoSmithKline

CPD

New Tools for Optimizing Medical Decision-Making and Clinical Trial Designs in Kidney Transplantation

Authors: Alexandre Loupy, MD, PhD; Stefan Berger, MD, PhD; Maarten Naesens, MD, PhD
CPD Released: 7/22/2020
THIS ACTIVITY HAS EXPIRED FOR CREDIT
Valid for credit through: 7/22/2021, 11:59 PM EST

Start Activity

Target Audience and Goal Statement

This educational activity is intended for an international audience of nephrologists, transplant surgeons, allergists, and clinical immunologists.

The goal of this activity is to educate physicians on the development of new tools that can help optimizing medical decision-making and advancing personalized treatment in kidney transplant patients

Upon completion of this activity, participants will:

Have increased knowledge regarding the
- Rationale for developing new tools to predict the risk of kidney transplant loss
- Clinical evidence for using prediction tool scores as surrogate endpoints in clinical trials vs traditional endpoints
Have greater competence related to
- Interpreting scores for individual patients with validated prediction tools

Disclosures

Faculty

Alexandre Loupy, MD, PhD

Professor of Nephrology
Head of Team at National Institute of Medical Research
Paris, France

Disclosures

Disclosure: Alexandre Loupy, MD, PhD, has disclosed no relevant financial relationships.

Stefan Berger, MD, PhD

Professor Head, Nephrology Department
University Medical Centre Groningen
Groningen, Netherlands

Disclosures

Disclosure: Stefan Berger, MD, PhD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: Novartis Pharmaceuticals Corporation
Served as a speaker or a member of a speakers bureau for: Novartis Pharmaceuticals Corporation
Received grants for clinical research from: Chiesi Pharmaceuticals, Inc.; Novartis Pharmaceuticals Corporation

Maarten Naesens, MD, PhD

Professor of Microbiology
Immunology, and Transplantation
KU Leuven
Nephrologist, University Hospitals Leuven
Leuven, Belgium

Disclosures

Disclosure: Maarten Naesens, MD, PhD, has disclosed no relevant financial relationships.

Editors

Marinella Calle, PhD, CMPP

Medical Education Director, WebMD Global, LLC

Disclosures

Disclosure: Marinella Calle, PhD, CMPP, has disclosed no relevant financial relationships.

Ryan Blanchard, PhD

Medical Education Director, WebMD Global, LLC

Disclosures

Disclosure: Ryan Blanchard, PhD, has disclosed no relevant financial relationships.

Content Reviewer

Robert Morris, PharmD

Associate Director, Accreditation and Compliance

Disclosures

Disclosure: Robert Morris, PharmD, has disclosed the following relevant financial relationships:
Served as an advisor or consultant for: ViiV Healthcare
Owns stock, stock options, or bonds from: GlaxoSmithKline

Accreditation Statements

For Physicians

The Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom (FPM) has reviewed and approved the content of this educational activity and allocated it 0.50 continuing professional development credits (CPD).

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From Medscape Education

CPD

New Tools for Optimizing Medical Decision-Making and Clinical Trial Designs in Kidney Transplantation

Authors: Alexandre Loupy, MD, PhD; Stefan Berger, MD, PhD; Maarten Naesens, MD, PhDFaculty and Disclosures

THIS ACTIVITY HAS EXPIRED FOR CREDIT

CPD Released: 7/22/2020

Valid for credit through: 7/22/2021, 11:59 PM EST

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Educational Impact Challenge

The goal of this activity is to educate physicians on the development of new tools that can help optimizing medical decision-making and advancing personalized treatment in kidney transplant patients

Before you begin this activity, please assess your clinical knowledge by completing this brief survey. Answering these questions again after the activity will allow you to see what you learned and to compare your answers with those of your peers.

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Disclaimer

The educational activity presented above may involve simulated, case-based scenarios. The patients depicted in these scenarios are fictitious and no association with any actual patient, whether living or deceased, is intended or should be inferred. The material presented here does not necessarily reflect the views of Medscape, LLC, or any individuals or commercial entities that support companies that support educational programming on medscape.org. These materials may include discussion of therapeutic products that have not been authorized by the European Medicines Agency for use in Europe, off-label uses of authorized products, or data that were presented in abstract form. These data should be considered preliminary until published in a peer-reviewed journal. Readers should verify all information and data before treating patients or employing any therapies described in this or any educational activity. A qualified healthcare professional should be consulted before using any therapeutic product discussed herein.

References

Faculty and Disclosures

Faculty

Alexandre Loupy, MD, PhD

Stefan Berger, MD, PhD

Maarten Naesens, MD, PhD

Editors

Marinella Calle, PhD, CMPP

Ryan Blanchard, PhD

Content Reviewer

Robert Morris, PharmD

CPD

New Tools for Optimizing Medical Decision-Making and Clinical Trial Designs in Kidney Transplantation

Target Audience and Goal Statement

Disclosures

Faculty

Alexandre Loupy, MD, PhD

Stefan Berger, MD, PhD

Maarten Naesens, MD, PhD

Editors

Marinella Calle, PhD, CMPP

Ryan Blanchard, PhD

Content Reviewer

Robert Morris, PharmD

Accreditation Statements

For Physicians

Instructions for Participation and Credit

New Tools for Optimizing Medical Decision-Making and Clinical Trial Designs in Kidney Transplantation

Educational Impact Challenge