title: OPPORTUNITY&trade;: a large-scale randomized clinical trial of growth hormone in hemodialysis patients.
abstract: BACKGROUND
  Adult maintenance hemodialysis (MHD) patients experience high mortality and morbidity and poor quality of life (QoL). Markers of protein-energy wasting are associated with these poor outcomes. The OPPORTUNITY™ Trial examined whether recombinant human growth hormone (hGH) reduces mortality in hypoalbuminemic MHD patients. Secondary end points were effects on number of hospitalizations, cardiovascular events, lean body mass (LBM), serum proteins, exercise capacity, QoL and adverse events.
  
  
  METHODS
  We performed a randomized, double-blind, placebo-controlled, multicenter multinational trial stratified for diabetic status. Clinically, stable adult MHD patients with serum albumin <4.0 g/dL were randomized to subcutaneous injections of hGH, 20 μg/kg/day, or placebo. Planned treatment duration was 24 months for 2500 patients. The trial was terminated early due to slow recruitment.
  
  
  RESULTS
  Seven hundred and twelve patients were randomized until trial termination; 695 patients received at least one dose of trial medication. Mean treatment duration was 20 weeks (no completers). There were no differences between groups in all-cause mortality, cardiovascular morbidity or mortality, serum albumin, LBM, physical exercise capacity or QoL. The hGH group, compared to placebo, displayed a reduction in body weight, total body fat, serum high-sensitivity C-reactive protein and possibly homocysteine and an increase in serum high-density lipoprotein-cholesterol and transferrin levels.
  
  
  CONCLUSIONS
  Although the OPPORTUNITY™ Trial was terminated early, treatment with hGH, compared to placebo, improved certain cardiovascular risk factors but did not reduce mortality, cardiovascular events or improve nutritional factors or QoL. The power for showing differences was substantially reduced due to the marked decrease in treatment duration and sample size.
authors.affiliation: Department of Medicine, Harbor-UCLA Medical Center, Torrance, CA, USA. jkopple@labiomed.org
authors.forename: Joel D
authors.initials: JD
authors.lastname: Kopple
authors.forename: Alfred K
authors.initials: AK
authors.lastname: Cheung
authors.forename: Jens Sandahl
authors.initials: JS
authors.lastname: Christiansen
authors.forename: Christian Born
authors.initials: CB
authors.lastname: Djurhuus
authors.forename: Meguid
authors.initials: M
authors.lastname: El Nahas
authors.forename: Bo
authors.initials: B
authors.lastname: Feldt-Rasmussen
authors.forename: William E
authors.initials: WE
authors.lastname: Mitch
authors.forename: Christoph
authors.initials: C
authors.lastname: Wanner
authors.forename: Marie
authors.initials: M
authors.lastname: Göthberg
authors.forename: Talat Alp
authors.initials: TA
authors.lastname: Ikizler
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D019382:Human Growth Hormone / Q000627:therapeutic use*; D006801:Humans; D034141:Hypoalbuminemia / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis; D055815:Young Adult
chemical_list: D019382:Human Growth Hormone