GROWTH AFTER RECOMBINANT HUMAN GROWTH-HORMONE TREATMENT IN CHILDREN WITH CHRONIC-RENAL-FAILURE - REPORT OF A MULTICENTER RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY

Objective: To determine whether treatment with recombinant human growth hormone (rhGH) enhances growth rate in growth-retarded children with chronic renal failure. Design: One hundred twenty-five prepubertal growth-retarded children with chronic renal failure were randomly assigned to receive either rhGH (n = 82) or placebo (n = 43) for 2 years. Setting: The study was undertaken at 17 pediatric nephrology centers in the United States. Measurements: Growth rate, standardized height, bone age, fasting and 2-hour postprandial glucose and insulin levels, biochemical values, and insulin-like growth factor I and anti-growth hormone antibody levels were evaluated serially during the 2-year study period. Results: Standardized height increased from -2.94 to -1.55 in the rhGH group after 24 months of treatment, and decreased from -2.82 to -2.94 in the placebo group (p <0.00005). Patients in the rhGH group who completed 24 months of study (n = 55) had a greater growth rate during the first year (10.7 +/- 3.1 cm/yr) than during the second year (7.8 +/- 2.1 cm/yr) of treatment. These growth rates were significantly greater than those in the placebo group (n = 27) in the first (6.5 +/- 2.6 cm/yr) and second (5.5 +/- 1.9 cm/yr) years (p <0.00005 for both years). The mean Delta height age minus the Delta bone age was positive in the rhGH group, suggesting improved final height potential. There was no significant difference in the change in calculated creatinine clearance over baseline values in the rhGH group from that in the placebo group after 24 months of study (p = 0.63). Mean fasting and postprandial insulin values were elevated at 12 months but not at 24 months in the rhGH-treated patients. Mean tasting and 2-hour postprandial glucose values at 24 months were not significantly elevated over baseline values in either group.