Journal Article

OPPORTUNITY™: a large-scale randomized clinical trial of growth hormone in hemodialysis patients

Joel D. Kopple, Alfred K. Cheung, Jens Sandahl Christiansen, Christian Born Djurhuus, Meguid El Nahas, Bo Feldt-Rasmussen, William E. Mitch, Christoph Wanner, Marie Göthberg and Talat Alp Ikizler

in Nephrology Dialysis Transplantation

Published on behalf of European Renal Association - European Dialysis and Transplant Assoc

Volume 26, issue 12, pages 4095-4103
Published in print December 2011 | ISSN: 0931-0509
Published online July 2011 | e-ISSN: 1460-2385 | DOI: http://dx.doi.org/10.1093/ndt/gfr363
OPPORTUNITY™: a large-scale randomized clinical trial of growth hormone in hemodialysis patients

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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.

Keywords: cardiovascular disease; dialysis; growth factors; lean body mass; mortality

Journal Article.  5683 words.  Illustrated.

Subjects: Nephrology

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