Efficacy of a novel inhibitor of vascular adhesion protein-1 in reducing albuminuria in patients with diabetic kidney disease (ALBUM): a randomised, placebo-controlled, phase 2 trial

Publication date: Available online 6 November 2018Source: The Lancet Diabetes & EndocrinologyAuthor(s): Dick de Zeeuw, Ronny W Renfurm, George Bakris, Peter Rossing, Vlado Perkovic, Fan Fan Hou, Masaomi Nangaku, Kumar Sharma, Hiddo J L Heerspink, Alberto Garcia-Hernandez, Tobias E LarssonSummaryBackgroundMany patients with diabetic kidney disease have residual albuminuria and are at risk of disease progression. The ALBUM trial investigated the efficacy of a novel, orally active inhibitor of vascular adhesion protein-1, ASP8232, compared with placebo for reducing albuminuria in individuals with type 2 diabetes and chronic kidney disease.MethodsIn this randomised, double-blind, placebo-controlled phase 2 trial, we randomly assigned individuals (aged 18–85 years) from 64 clinical sites in nine European countries to receive ASP8232 40 mg or placebo orally once daily for 12 weeks using a web-based randomisation schedule (block size 4), stratified by country. Eligible patients had a urinary albumin-to-creatinine ratio (UACR) of 200–3000 mg/g, an estimated glomerular filtration rate of at least 25 mL/min per 1·73 m2 but lower than 75 mL/min per 1·73 m2, HbA1c less than 11·0% (97 mmol/mol), and stable treatment with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and antidiabetic medication for 3 months or more. The primary endpoint was mean change from baseline to week 12 in log-transformed first morning void UACR, which was assessed in all patients ...
Source: The Lancet Diabetes and Endocrinology - Category: Endocrinology Source Type: research