| Autor: |
Flavio Vincenti, Jim Kim, Deborah Gouveia, Gabrielle Pelle, Tracy J. Mayne, John F. Neylan |
| Jazyk: |
angličtina |
| Rok vydání: |
2021 |
| Předmět: |
|
| Zdroj: |
Kidney International Reports, Vol 6, Iss 2, Pp 296-303 (2021) |
| Druh dokumentu: |
article |
| ISSN: |
2468-0249 |
| DOI: |
10.1016/j.ekir.2020.11.001 |
| Popis: |
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. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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