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OPPORTUNITY^TM: A Randomized Clinical Trial of Growth Hormone on Outcome in Hemodialysis Patients

Joel D. Kopple^*, Alfred K. Cheung, Jens Sandahl Christiansen, Christian Born Djurhuus, Meguid El Nahas^||, Bo Feldt-Rasmussen^¶, Martin Lange, William E. Mitch^**, Christoph Wanner, Jonas Wiedemann, and T. Alp Ikizler

^* Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, David Geffen School of Medicine at UCLA and the UCLA School of Public Health, Torrance, California; Department of Medicine, University of Utah and Medical Service, Veterans Affairs Salt Lake City Healthcare System, Salt Lake City, Utah; Department of Endocrinology, M. Aarhus University Hospital, Aarhus, Denmark; NovoNordisk A/S, Copenhagen, Denmark; ^|| Sheffield Kidney Institute, Sheffield, United Kingdom; ^¶ Division of Nephrology, Rigshospitalet, University of Copenhagen, Denmark; ^** Division of Nephrology, Baylor College of Medicine, Houston, Texas; Department of Medicine, University of Wuerzburg, Wuerzburg, Germany; and Division of Nephrology, Vanderbilt University Medical Center, Nashville, Tennessee

Correspondence: Dr. Joel D. Kopple, Department of Medicine and Public Health, David Geffen School of Medicine at UCLA and UCLA School of Public Health, Division of Nephrology and Hypertension, Harbor-UCLA Medical Center, 1000 West Carson Street, Box 406, Torrance, CA 90509. Phone: 310-222-3891; Fax: 310-782-1837; E-mail: jkopple{at}labiomed.org

Background: The mortality rate of maintenance hemodialysis (MHD) patients remains high. Measures of protein-energy wasting, including hypoalbuminemia, are strongly associated with their high mortality. Growth hormone (GH) may improve lean body mass (LBM) and serum albumin levels, and health-related quality of life (HRQoL), which are significantly and positively associated with survival in MHD patients. The OPPORTUNITY^TM Trial will examine whether GH reduces mortality and morbidity and improves overall health in hypoalbuminemic MHD patients.

Hypothesis: The primary hypothesis is that daily recombinant human GH injections, compared with placebo, improve survival in hypoalbuminemic MHD patients. Secondary hypotheses are that GH improves morbidity and health, including number of hospitalized days, time to cardiovascular events, LBM, serum protein and inflammatory marker levels, exercise capacity, and HRQoL, and has a favorable safety profile.

Design/Measurements: This is a prospective, double-blind, multicenter, randomized clinical trial involving 2500 MHD patients, up to 50% with diabetes mellitus, from 22 countries. Patients are randomized in a 1:1 ratio to receive daily injections of GH (20 µg/kg per day) or placebo for 104 weeks. Key inclusion criteria include clinically stable and well-dialyzed (Kt/V 1.2) adult MHD patients with serum albumin <4.0 g/dl. Exclusion criteria include active malignancy, active proliferative or severe nonproliferative diabetic retinopathy, uncontrolled hypertension, chronic use of high-dose glucocorticoids, or immunosuppressive agents and pregnancy.

Conclusions: The OPPORTUNITY^TM Trial is the first large-scale randomized clinical trial in adult MHD patients evaluating the response to GH of such clinical endpoints as mortality, morbidity, markers of body protein mass, inflammation, exercise capacity, and HRQoL.