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Renal Function Improvement Following ANG-3777 Treatment in Patients at High Risk for Delayed Graft Function After Kidney Transplantation.
- Source :
-
Transplantation [Transplantation] 2021 Feb 01; Vol. 105 (2), pp. 443-450. - Publication Year :
- 2021
-
Abstract
- Background: Patients (20%-50%) undergoing renal transplantation experience acute kidney injury resulting in delayed graft function. ANG-3777 is an hepatocyte growth factor mimetic that binds to the c-MET receptor. In animal models, ANG-3777 decreases apoptosis, increases proliferation, and promotes organ repair and function.<br />Methods: This was a randomized, double-blind, placebo-controlled, phase 2 trial of patients undergoing renal transplantation with <50 cc/h urine output for 8 consecutive hours over the first 24 hours posttransplantation, or creatinine reduction ratio <30% from pretransplantation to 24 hours posttransplantation. Subjects were randomized as 2:1 to 3, once-daily IV infusions of ANG-3777, 2 mg/kg (n = 19), or placebo (n = 9). Primary endpoint: time in days to achieve ≥1200 cc urine for 24 hours.<br />Results: Patients treated with ANG-3777 were more likely to achieve the primary endpoint of 1200 cc urine for 24 hours by 28 days posttransplantation (83.3% versus 50% placebo; log-rank test: χ2 = 2.799, P = 0.09). Compared with placebo, patients in the ANG-3777 arm had larger increases in urine output; lower serum creatinine; greater reduction in C-reactive protein and neutrophil gelatinase-associated lipocalin; fewer dialysis sessions and shorter duration of dialysis; fewer hospital days; significantly less graft failure; and higher estimated glomerular filtration rate. Adverse events occurred in a similar percentage of subjects in both arms. Events per subject were twice as high in the placebo arm.<br />Conclusions: There was an efficacy signal for improved renal function in subjects treated with ANG-3777 relative to placebo, with a good safety profile.<br /> (Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc.)
- Subjects :
- Acute Kidney Injury etiology
Acute Kidney Injury physiopathology
Adult
Aged
Creatinine blood
Delayed Graft Function etiology
Delayed Graft Function physiopathology
Double-Blind Method
Female
Glomerular Filtration Rate drug effects
Humans
Kidney physiopathology
Male
Middle Aged
Pyrazoles adverse effects
Recovery of Function
Thiophenes adverse effects
Time Factors
Treatment Outcome
United States
Urodynamics drug effects
Acute Kidney Injury drug therapy
Delayed Graft Function drug therapy
Kidney drug effects
Kidney surgery
Kidney Transplantation adverse effects
Pyrazoles therapeutic use
Thiophenes therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1534-6080
- Volume :
- 105
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Transplantation
- Publication Type :
- Academic Journal
- Accession number :
- 32265417
- Full Text :
- https://doi.org/10.1097/TP.0000000000003255