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Growth Hormone Treatment during Hemodialysis in a Randomized Trial Improves Nutrition, Quality of Life, and Cardiovascular Risk

Bo Feldt-Rasmussen^*, Martin Lange, Wladyslaw Sulowicz, Uzi Gafter, Kar Neng Lai^||, Jonas Wiedemann^**, Jens Sandal Christiansen^¶, Meguid El Nahas and the Adult Patients in Chronic Dialysis (APCD) Study Group

^* Department of Nephrology, Copenhagen University Hospital, Copenhagen, Denmark; Novo Nordisk Inc, Princeton, New Jersey; Department of Nephrology, Jagiellonian University, Krakow, Poland; Department of Nephrology and Hypertension, Rabin Medical Center, Petah Tikva, Israel; ^|| Department of Medicine, University of Hong Kong, Hong Kong; ^¶ Department of Endocrinology and Diabetes, Århus University Hospital, Århus, Denmark; ^** Novo Nordisk A/S, Bagsvaerd, Denmark; and Sheffield Kidney Institute, Northern General Hospital, Sheffield, United Kingdom

Correspondence: Dr. Bo Feldt-Rasmussen, Rigshospitalet Copenhagen University Hospital, 9, Blegdamsvej, Department of Nephrology P2132, DK-2100 Copenhagen, Denmark. Phone: +45-3545-2135; Fax: +45-3545-2607; E-mail: bfr{at}rh.dk

Received for publication November 6, 2006. Accepted for publication April 13, 2007.

Nutritional markers, such as lean body mass (LBM) and serum albumin, predict outcome in dialysis patients, in whom protein-energy malnutrition is associated with increased morbidity and mortality. The metabolic effects of human growth hormone (hGH) may improve the nutritional and cardiovascular health of these patients and consequently reduce morbidity and mortality. The aim of this study was to establish clinical proof of concept of hGH treatment for the improvement of the nutritional status in adult patients who are on maintenance hemodialysis. A total of 139 adult patients who were on maintenance hemodialysis and had serum albumin levels 40 g/L were randomly assigned to 6 mo of treatment with placebo or 20, 35, or 50 µg/kg per d hGH. Change in LBM and serum albumin (primary outcomes), health-related quality of life, and secondary efficacy and safety parameters were monitored. The study showed that hGH treatment increased LBM significantly at all dosage levels (2.5 kg [95% confidence interval 1.8 to 3.1] versus –0.4 kg [95% confidence interval –1.4 to 0.6]; P < 0.001 for pooled hGH groups versus placebo). Serum albumin tended to increase (P = 0.076), serum transferrin (P = 0.001) and serum HDL (P < 0.038) increased, and plasma homocysteine was reduced (P = 0.029). TNF- also tended to decrease with treatment (P = 0.134). An improvement in the Role Physical SF-36 quality-of-life subscale was observed (P = 0.042). There were no differences in clinically relevant adverse events between groups. In conclusion, hGH therapy safely improves LBM, other markers of mortality and morbidity, and health-related quality of life in adult patients who are on maintenance hemodialysis. A long-term study is warranted to investigate whether these treatment benefits result in reduced mortality and morbidity.

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