title: Open-labeled randomized controlled trial to compare diuretic therapy with recombinant human serum albumin and diuretic therapy for therapeutic treatment of ascites in patients with advanced liver cirrhosis: An exploratory trial.
abstract: OBJECTIVE
  There have been only a few trials demonstrating additional effects of human serum albumin (HSA) on diuretic therapy in patients with cirrhotic ascites. We aimed to evaluate the safety and efficacy of recombinant HSA, KD-294, treatment in patients with cirrhotic ascites.
  
  
  METHODS
  The inclusion criteria were patients 20-75 years of age, with cirrhotic ascites and a serum albumin concentration of less than 3.0 g/dL. Eighty-five patients were registered and 71 patients underwent randomization. Enrolled patients received oral spironolactone at 50 mg/day and i.v. furosemide at 20 mg/day in addition to low-sodium diet. They were divided randomly into a KD-294 treatment group (n = 35) or non-treatment control group (n = 36). Patients in the KD-294 group received KD-294 at 25 g/day for up to 5 days and those in the control group continued the diuretic therapy. They were followed up for 5 weeks.
  
  
  RESULTS
  KD-294 was well tolerated. A correlation between the increases in serum albumin and decreases in bodyweight was not shown. However, changes of plasma renin concentration (PRC) showed a significant decrease in the KD-294 group compared with the control group. As a result of this exploratory analysis, patients with high PRC showed a significant correlation between increases in serum albumin and decreases in bodyweight.
  
  
  CONCLUSIONS
  The present data do not show efficacy in all patients with cirrhotic ascites, however, they suggest that additional effects of HSA on diuretic therapy are expected in high PRC patients.
authors.affiliation: Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan; Liver Cancer Division, Research Center for Innovative Cancer Therapy, Kurume University, Kurume, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Nakamura
authors.forename: Michio
authors.initials: M
authors.lastname: Sata
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Suzuki
authors.forename: Hisataka
authors.initials: H
authors.lastname: Moriwaki
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Fukui
authors.forename: Shigetoshi
authors.initials: S
authors.lastname: Fujiyama
authors.forename: Michio
authors.initials: M
authors.lastname: Imawari
keywords: KD-294; ascites; liver cirrhosis; recombinant human serum albumin