A PLACEBO-CONTROLLED, DOUBLE-BLIND TRIAL OF GROWTH-HORMONE TREATMENT IN PREPUBERTAL CHILDREN AFTER RENAL-TRANSPLANT

Sustained growth retardation in spite of a successful renal transplant ation (RTx) is a serious problem for many pediatric allograft recipien ts. Biosynthetic growth hormone (GH) was given to 11 prepubertal child ren with severe growth retardation after RTx in a placebo-controlled d ouble-blind study, assessing its effect on height velocity (HV), bone maturation, renal function, plasma IGF-I and IGF-II, serum IGF-binding proteins (IGFBP), and lipid and carbohydrate metabolism. Six months o f GH (4 IU/m(2)/day s.c.) was either preceded or followed by six month s of placebo. The patients underwent a full examination every three mo nths. All children completed the study. Mean HV improved significantly with GH therapy (P < 0.0001), but there was also some improvement wit h placebo (P = 0.06). The GH-induced HV increment exceeded that of pla cebo by 2.9 cm/six months. Bone maturation was not accelerated. Acute renal graft rejection did not occur in any of the patients. I-125-thal amate and I-131-hippuran tests showed that mean glomerular filtration rate (GFR) and effective renal plasma flow (ERPF) did not change signi ficantly during GH therapy. GH caused a significant increase in IGF-I (P < 0.0001), which was far greater than the insignificant increase in serum IGFBP-3 levels (P = 0.16). Mean serum levels of total cholester ol, low density lipoprotein, apolipoprotein-Al and -B, which were elev ated at the start of the study compared with that of controls, did not change significantly during GH therapy. GH induced a significant incr ease in mean integrated plasma insulin levels during oral glucose tole rance test, without changing plasma glucose levels. Serum fructosamine and parathyroid hormone levels remained constant. Impressive KV incre ment can be achieved with GH therapy in children with growth retardati on after RTx, without significant changes in renal function. Bone matu ration appears unaffected, suggesting an improved final height.