Randomized Study to Investigate the Effects on Growth and the Safety of the Treatment with Recombinant Growth Hormone in 1 to 2-year-old Children with Growth Retardation Due to Chronic Kidney Failure

Title of the Study RANDOMIZED STUDY TO INVESTIGATE THE EFFECTS ON GROWTH AND THE SAFETY OF THE TREATMENT WITH RECOMBINANT GROWTH HORMONE IN 1 TO 2-YEAR-OLD CHILDREN WITH GROWTH RETARDATION DUE TO CHRONIC KIDNEY FAILURE Investigator(s) Multicenter Coordinator: Dr. Fernando Santos Investigating Center(s) Multicenter Coordinating center: Hospital Central de Asturias, Oviedo Publications Study Period January 1998 to September 2005 Phase IV Objectives Growth retardation due to chronic renal failure. Methodology Stratified, randomized, open-label study, in parallel and comparative with a control group without treatment Number of expected and analyzed subjects y 16 children have been included in the study. One patient is eliminated from the intent-to-treat (ITT) analysis due to abandoning the study before the first follow-up visit and because no postbaseline data was available, although this patient was included in the safety analysis Diagnosis and Main Inclusion Criteria Children with growth retardation (height ≤ -2 SDS for chronological age and sex and rate of growth in height < P50 for chronological age and sex) due to chronic renal failure (glomerular filtration rate ≤ 60 ml/min./1.73 m). Product under study, dose and method of administration, batch numbers rhGH. One daily dose of rhGH (0.33 mg/kg/week) administered subcutaneously between 8 p.m. and 10 p.m..