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OBJECTIVES:
I. Assess the clinical safety and long term effects of recombinant human growth hormone on a defined range of nutritional indices in malnourished chronic hemodialysis and continuous ambulatory peritoneal dialysis patients.
Full description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo-controlled, cross-over study.
Prior to randomization each patient's protein and calorie intake is assessed and optimized as possible. Patients are randomized to receive either placebo or recombinant human growth hormone subcutaneously every other day for 6 months. At the end of this 6 month period, patients undergo a 4 week washout period. After the washout period, patients are crossed-over to the alternate regimen for an additional 6 months followed by another 4 week washout period.
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PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Patient Characteristics--
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Data sourced from clinicaltrials.gov
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