Cargando…

Phase 3 trial Design of the Hepatocyte Growth Factor Mimetic ANG-3777 in Renal Transplant Recipients With Delayed Graft Function

INTRODUCTION: One-third of kidney transplantation patients experience acute kidney injury (AKI) resulting in delayed graft function (DGF), associated with increased risk of graft failure and mortality. Preclinical and phase 2 data indicate that treatment with ANG-3777 (formerly BB3), a hepatocyte gr...

Descripción completa

Detalles Bibliográficos
Autores principales: Vincenti, Flavio, Kim, Jim, Gouveia, Deborah, Pelle, Gabrielle, Mayne, Tracy J., Neylan, John F.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7879201/
https://www.ncbi.nlm.nih.gov/pubmed/33615054
http://dx.doi.org/10.1016/j.ekir.2020.11.001
_version_ 1783650484161085440
author Vincenti, Flavio
Kim, Jim
Gouveia, Deborah
Pelle, Gabrielle
Mayne, Tracy J.
Neylan, John F.
author_facet Vincenti, Flavio
Kim, Jim
Gouveia, Deborah
Pelle, Gabrielle
Mayne, Tracy J.
Neylan, John F.
author_sort Vincenti, Flavio
collection PubMed
description INTRODUCTION: One-third of kidney transplantation patients experience acute kidney injury (AKI) resulting in delayed graft function (DGF), associated with increased risk of graft failure and mortality. Preclinical and phase 2 data indicate that treatment with ANG-3777 (formerly BB3), a hepatocyte growth factor (HGF) mimetic, may improve long-term kidney function and reduce health care resource use and cost, but these data require validation in a phase 3 randomized controlled trial. METHODS: The Graft Improvement Following Transplant (GIFT) trial is a multicenter, double-blind randomized controlled trial, designed to determine the efficacy and safety of ANG-3777 in renal transplantation patients showing signs of DGF. Subjects are randomized 1:1 to ANG-3777 (2 mg/kg) administered intravenously once daily for 3 consecutive days starting within 30 hours after transplantation, or to placebo. RESULTS: The primary endpoint is estimated glomerular filtration rate (eGFR) at 12 months. Secondary endpoints include proportion of subjects with eGFR >30 at days 30, 90, 180, and 360; proportion of subjects whose graft function is slow, delayed, or primary nonfunction; length of hospitalization; and duration of dialysis through day 30. Adverse events are assessed throughout the study. CONCLUSION: GIFT will generate data that are important to advancing treatment of DGF in this medically complex population.
format Online
Article
Text
id pubmed-7879201
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher Elsevier
record_format MEDLINE/PubMed
spelling pubmed-78792012021-02-18 Phase 3 trial Design of the Hepatocyte Growth Factor Mimetic ANG-3777 in Renal Transplant Recipients With Delayed Graft Function Vincenti, Flavio Kim, Jim Gouveia, Deborah Pelle, Gabrielle Mayne, Tracy J. Neylan, John F. Kidney Int Rep Clinical Research INTRODUCTION: One-third of kidney transplantation patients experience acute kidney injury (AKI) resulting in delayed graft function (DGF), associated with increased risk of graft failure and mortality. Preclinical and phase 2 data indicate that treatment with ANG-3777 (formerly BB3), a hepatocyte growth factor (HGF) mimetic, may improve long-term kidney function and reduce health care resource use and cost, but these data require validation in a phase 3 randomized controlled trial. METHODS: The Graft Improvement Following Transplant (GIFT) trial is a multicenter, double-blind randomized controlled trial, designed to determine the efficacy and safety of ANG-3777 in renal transplantation patients showing signs of DGF. Subjects are randomized 1:1 to ANG-3777 (2 mg/kg) administered intravenously once daily for 3 consecutive days starting within 30 hours after transplantation, or to placebo. RESULTS: The primary endpoint is estimated glomerular filtration rate (eGFR) at 12 months. Secondary endpoints include proportion of subjects with eGFR >30 at days 30, 90, 180, and 360; proportion of subjects whose graft function is slow, delayed, or primary nonfunction; length of hospitalization; and duration of dialysis through day 30. Adverse events are assessed throughout the study. CONCLUSION: GIFT will generate data that are important to advancing treatment of DGF in this medically complex population. Elsevier 2020-11-13 /pmc/articles/PMC7879201/ /pubmed/33615054 http://dx.doi.org/10.1016/j.ekir.2020.11.001 Text en © 2020 International Society of Nephrology. Published by Elsevier Inc. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Clinical Research
Vincenti, Flavio
Kim, Jim
Gouveia, Deborah
Pelle, Gabrielle
Mayne, Tracy J.
Neylan, John F.
Phase 3 trial Design of the Hepatocyte Growth Factor Mimetic ANG-3777 in Renal Transplant Recipients With Delayed Graft Function
title Phase 3 trial Design of the Hepatocyte Growth Factor Mimetic ANG-3777 in Renal Transplant Recipients With Delayed Graft Function
title_full Phase 3 trial Design of the Hepatocyte Growth Factor Mimetic ANG-3777 in Renal Transplant Recipients With Delayed Graft Function
title_fullStr Phase 3 trial Design of the Hepatocyte Growth Factor Mimetic ANG-3777 in Renal Transplant Recipients With Delayed Graft Function
title_full_unstemmed Phase 3 trial Design of the Hepatocyte Growth Factor Mimetic ANG-3777 in Renal Transplant Recipients With Delayed Graft Function
title_short Phase 3 trial Design of the Hepatocyte Growth Factor Mimetic ANG-3777 in Renal Transplant Recipients With Delayed Graft Function
title_sort phase 3 trial design of the hepatocyte growth factor mimetic ang-3777 in renal transplant recipients with delayed graft function
topic Clinical Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7879201/
https://www.ncbi.nlm.nih.gov/pubmed/33615054
http://dx.doi.org/10.1016/j.ekir.2020.11.001
work_keys_str_mv AT vincentiflavio phase3trialdesignofthehepatocytegrowthfactormimeticang3777inrenaltransplantrecipientswithdelayedgraftfunction
AT kimjim phase3trialdesignofthehepatocytegrowthfactormimeticang3777inrenaltransplantrecipientswithdelayedgraftfunction
AT gouveiadeborah phase3trialdesignofthehepatocytegrowthfactormimeticang3777inrenaltransplantrecipientswithdelayedgraftfunction
AT pellegabrielle phase3trialdesignofthehepatocytegrowthfactormimeticang3777inrenaltransplantrecipientswithdelayedgraftfunction
AT maynetracyj phase3trialdesignofthehepatocytegrowthfactormimeticang3777inrenaltransplantrecipientswithdelayedgraftfunction
AT neylanjohnf phase3trialdesignofthehepatocytegrowthfactormimeticang3777inrenaltransplantrecipientswithdelayedgraftfunction