RECOMBINANT HUMAN GROWTH-HORMONE IN INFANTS AND YOUNG-CHILDREN WITH CHRONIC RENAL-INSUFFICIENCY

Children with chronic renal insufficiency (CRI) secondary to congenita l structural abnormalities frequently have significant growth retardat ion by 2 years of age. In a multicenter placebo-controlled study of th e use of recombinant human growth hormone (rhGH), 30 of 125 (24%) part icipants were < 2.5 years of age at enrollment, Since the treatment ar ms of the study were balanced for age at randomization, data for these patients were examined for efficacy and safety. During the first 2 ye ars of the study, approximately two-thirds of the patients (n = 19) re ceived rhGH 0.05 mg/kg per day subcutaneously and one-third (n = 11) r eceived placebo injections, At entry into the study, the mean (+/- SD) calculated creatinine clearance was 29.2 +/- 14.3 (range 12.0 - 63.7) ml/min per 1.73 m(2) in the rhGH-treated group and 23.3 +/- 15.1 (ran ge 8.0 - 59.4) ml/min per 1.73 m(2) in the placebo-treated group, The 1st year growth rate was 14.1 +/- 2.6 cm/year for the rhGH-treated gro up and 9.3 +/- 1.5 cm/year in the placebo-treated group (P < 0.00005). During the 2nd year of the study, the growth rate was 8.6 +/- 1.2 cm/ year in the rhGH-treated group compared with 6.9 +/- 1.0 in the placeb o group (P = 0.025). The Delta height standard deviation score was +2. 0 +/- 0.7 for the rhGH-treated group compared with -0.2 +/- 1.1 in the placebo-treated group (P < 0.00005) during the 2 years of the study. Minor adverse events occurred with similar frequency in both groups. T hese data suggest that rhGH is efficacious and safe in children with C RI under age 2.5 years. rhGH therapy may correct significant loss of g rowth at this age when used in conjunction with optimal medical manage ment.