Phase 3 trial Design of the Hepatocyte Growth Factor Mimetic ANG-3777 in Renal Transplant Recipients With Delayed Graft Function
| Autor: | Gabrielle Pelle, John F. Neylan, Tracy J. Mayne, Deborah Gouveia, Flavio Vincenti, Jim Kim |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
medicine.medical_treatment Population 030232 urology & nephrology Urology Renal function kidney transplantation 030204 cardiovascular system & hematology lcsh:RC870-923 law.invention 03 medical and health sciences 0302 clinical medicine delayed graft function Randomized controlled trial law Clinical Research medicine Clinical endpoint eGFR education Kidney transplantation Dialysis education.field_of_study business.industry Acute kidney injury medicine.disease lcsh:Diseases of the genitourinary system. Urology Transplantation hepatocyte growth factor acute kidney injury Nephrology business ANG-3777 |
| Zdroj: | Kidney International Reports, Vol 6, Iss 2, Pp 296-303 (2021) Kidney International Reports |
| ISSN: | 2468-0249 |
| 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. Graphical abstract |
| Databáze: | OpenAIRE |
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