Articles tagged "Multicenter studies"

2020 American Transplant Congress
The State of Interventional Clinical Trials in Solid Organ Transplant: Insights from a Systematic Analysis of Clinicaltrials.gov
A. C. Swaminathan¹, J. Li¹, K. Chiswell¹, W. McManigle¹, I. O’Doherty², W. Fitzsimmons³, J. L. Todd¹, S. Tibbs⁴, S. M. Palmer¹
¹Duke Clinical Research Institute, Durham, NC, ²Critical Path Institute, Tuscan, AZ, ³Fitzsimmons LLC, Chicago, IL, ⁴Duke University, Durham, NC
*Purpose: The approach to immunosuppression after solid organ transplant has remained relatively unchanged for almost 20 years, despite the high prevalence of immunosuppression-related complications and…
2020 American Transplant Congress
A Monocyte-Derived MicroRNA Signature for Antibody-Mediated Rejection in Kidney Transplantation
C. Tinel¹, B. Lamarthée¹, F. Von Tokarski¹, M. Rabant², C. Legendre¹, W. Gwinner³, M. Naesens⁴, P. Marquet⁵, D. Anglicheau¹
¹Kidney Transplantation, Inserm U1151, Necker Hospital, Paris, France, ²Pathology, Necker Hospital, Paris, France, ³Nephrology, Hannover Medical School, Hannover, Germany, ⁴Nephrology and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium, ⁵Nephrology, Dialysis and Transplantation, Inserm U850, Limoges University Hospital, Limoges, France
*Purpose: MicroRNAs (miRNAs) are small noncoding RNAs which regulate mRNA expression at the posttranscriptional level. We investigated blood miRNAs as non-invasive biomarkers in kidney transplantation…
2020 American Transplant Congress
RNA Sequencing of Urine RNA Samples for Biomarker Discovery
K. S. Keslar¹, D. Margeta¹, M. Abecassis², J. J. Friedewald², P. S. Heeger³, R. L. Fairchild¹
¹Cleveland Clinic, Cleveland, OH, ²Northwestern University, Chicago, IL, ³Icahn School of Medicine, New York, NY
*Purpose: An accurate, noninvasive assay based on urinary gene expression profiles would be a powerful tool for clinical management of kidney transplant patients. We have…
2020 American Transplant Congress
TRANSFORM Study (NCT01950819): Application of the Ibox Clinical Trial Simulation Tool to Project Long-Term Kidney Allograft Outcome
G. Divard¹, O. Aubert¹, M. Raynaud¹, J. Pascual², F. Vincenti³, P. Bernhardt⁴, C. Legendre¹, A. Loupy¹, .. on behalf of TRANSFORM Investigators⁵
¹INSERM U970, Paris Transplant Group, Paris, France, ²Department of Nephrology, Hospital del Mar/Universitat Autònoma de Barcelona, Barcelona, Spain, ³Department of Surgery/Kidney Transplant Service, University of California, San Francisco, CA, ⁴Research and Development, Novartis Pharma AG, Basel, Switzerland, ⁵TRANSFORM Investigators, Basel, Switzerland
*Purpose: The development of pharmaceutical agents in transplantation is currently limited by long waits for hard endpoints. We sought to use a risk stratification system…
2020 American Transplant Congress
Noninvasive Detection of Subclinical Rejection in Urine RNA
K. S. Keslar¹, D. Margeta¹, J. J. Friedewald², M. Abecassis², R. B. Mannon³, P. S. Heeger⁴, R. L. Fairchild¹
¹Cleveland Clinic, Cleveland, OH, ²Northwestern University, Chicago, IL, ³University of Alabama at Birmingham, Birmingham, AL, ⁴Icahn School of Medicine, New York, NY
*Purpose: Subclinical rejection may lead to long-term graft injury and can currently only be detected by repeated biopsies. A noninvasive method is needed to monitor…
2020 American Transplant Congress
Three-Month Results of a Phase 2 Trial Evaluating Clazakizumab in Late Antibody-Mediated Rejection – Early Impact of Interleukin-6 Blockade on Donor-Specific Antibody Levels, Rejection Morphology and Gene Expression
G. A. Böhmig¹, M. Dürr², B. Jilma³, F. Eskandary¹, E. Chong⁴, S. Schranz³, K. Doberer¹, M. Wahrmann¹, A. Borski¹, H. Regele⁵, J. Kläger⁵, R. Reindl-Schwaighofer¹, J. Reeve⁶, K. Budde², P. F. Halloran⁶
¹Department of Medicine III, Medical University of Vienna, Vienna, Austria, ²Nephrology Department, Charité Berlin, Berlin, Germany, ³Dept. of Clin. Pharmacology, Medical University of Vienna, Vienna, Austria, ⁴Vitaeris Inc., Vancouver, BC, Canada, ⁵Dept. of Clin. Pathology, Medical University of Vienna, Vienna, Austria, ⁶Alberta Transplant Applied Genomics Centre, ATAGC, University of Alberta, Edmonton, AB, Canada
*Purpose: Targeting Interleukin-6 (IL-6) is a promising strategy to counteract antibody-mediated rejection (ABMR). This phase 2 trial (NCT03444103) was designed to evaluate the safety and…
2020 American Transplant Congress
Care Processes and Structures Associated with Higher Medication Adherence: The Positive Adherence Study
A. Dabirzadeh¹, B. Foster¹, M. Dahhou¹, S. Mital²
¹Research Institute of the McGill University Health Centre, Montreal, QC, Canada, ²Hospital for Sick Children, Toronto, ON, Canada
*Purpose: We aimed to identify care processes and structures that are independently associated with higher medication adherence among adolescent and young adult transplant recipients.*Methods: We…
2020 American Transplant Congress
Burnout and Professional Fulfillment among Pediatric Sold Organ Transplant Clinicians Pediatric Transplant
C. Bogle¹, M. K. Cousino Hood², E. M. Fredericks³, J. Magee⁴, S. Warren¹, E. Blume¹
¹Advanced Cardiac Therapies, Boston Children's Hospital, Boston, MA, ²Pediatric Cardiology, C.S. Mott Children's Hospital, Ann Arbor, MI, ³Pediatric Psychology, C.S. Mott Children's Hospital, Ann Arbor, MI, ⁴Transplant, C.S. Mott Children's Hospital, Ann Arbor, MI
*Purpose: Burnout has been associated with worse patient outcomes with increased medical errors and nosocomial infections as well as adverse effect on healthcare providers, such…
2020 American Transplant Congress
Automated Monitoring of Four Urinary Biomarkers in Routine Surveillance Identifies Patients at Low and High Risk of Renal Allograft Injury
L. Sheward¹, J. Wedel¹, N. Rodig¹, R. Mannon², O. Bestard³, V. Dharnidharka⁴, D. Zurakowski¹, A. Kho¹, T. Blydt-Hansen⁵, M. Seifert², D. M. Briscoe¹
¹Boston Children's Hospital, Boston, MA, ²University of Alabama at Birmingham, Birmingham, AL, ³Bellvitge University Hospital, Barcelona, Spain, ⁴St Louis Children's Hospital, St Louis, MO, ⁵BC Children's Hospital, Vancouver, BC, Canada
*Purpose: Surveillance renal biopsy data indicate that up to 36% of clinically stable kidney allograft recipients have subclinical rejection, emphasizing the need to implement automated…
2020 American Transplant Congress
Impact of Extended- versus Immediate-Release Tacrolimus on One-Year Development of De Novo DSA and Chronic Immune Activation in Kidney Transplantation (ASTOUND Study)
A. Wiseman¹, D. Kaufman², A. Patel³, D. Wojciechowski⁴, A. Tambur⁵, J. Kim⁶, J. Schwartz⁶
¹University of Colorado Hospital, Aurora, CO, ²University of Wisconsin, Madison, WI, ³Henry Ford Hospital, Detroit, MS, ⁴Massachusetts General Hospital, Boston, MA, ⁵Northwestern University, Chicago, IL, ⁶Astellas Pharma Global Development, Northbrook, IL
*Purpose: To compare, using an adaptive study design, the 1-year incidence of a novel two-part composite endpoint consisting of de novo donor-specific antibody (dnDSA) formation…