title: Treatment of growth failure with growth hormone in children with chronic kidney disease: an open-label long-term study.
abstract: OBJECTIVE
  To assess long-term efficacy and safety of recombinant human growth hormone (GH) in children with chronic kidney disease (CKD).
  
  
  METHODS
  An open-label, international, multicenter study. Children with CKD and growth failure received GH (0.35 mg/kg/week). The primary efficacy endpoint was a significant change in height velocity (HV) and height standard deviation score (SDS) versus baseline after 12 months of treatment, extended to 24 months, then to 5 years.
  
  
  RESULTS
  In total, 81 patients enrolled (CKD Stage 4 - 5 = 37, on dialysis = 27, post-transplant = 17). After 12 and 24 months of treatment, increases were seen in mean (SD) HV (4.6 (3.1) to 9.0 (3.6) cm/year and 4.5 (3.3) to 7.5 (2.9) cm/year, respectively; both p < 0.001), mean (SD) height SDS (-3.7 (1.7) to -3.0 (1.7) and -3.6 (1.5) to -2.5 (1.5), respectively; both p < 0.001) and mean (SD) HV SDS (-2.4 (2.5) to 3.8 (4.5) and -2.4 (2.2) to 1.1 (3.8), respectively; both p < 0.001). A normal height SDS was seen in 1% of children at baseline, 17% after 12 months and 43% after 24 months of treatment. Improvements were similar across CKD subgroups with the greatest improvements in CKD Stage 4 - 5. Among 31 patients who completed about 5 years of treatment, four reached final height. There was no undue bone age acceleration and no deterioration of kidney function. Ten adverse events were related to GH treatment.
  
  
  CONCLUSIONS
  In this long-term study, GH treatment was associated with significant improvements in growth and height in children with CKD and growth failure, and was well tolerated.
authors.affiliation: Paediatric Nephrology, University Medical Center, Hamburg, Germany. muellerw@uke.uni-hamburg.de
authors.forename: D
authors.initials: D
authors.lastname: Müller-Wiefel
authors.forename: H
authors.initials: H
authors.lastname: Frisch
authors.forename: T
authors.initials: T
authors.lastname: Tulassay
authors.forename: L
authors.initials: L
authors.lastname: Bell
authors.forename: Z
authors.initials: Z
authors.lastname: Zadik
mesh_terms: D000704:Analysis of Variance; D001827:Body Height / Q000187:drug effects; D002648:Child; D002657:Child Development / Q000187:drug effects*; D005260:Female; D006130:Growth Disorders / Q000188:drug therapy* / Q000503:physiopathology; D019382:Human Growth Hormone / Q000627:therapeutic use*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000503:physiopathology* / Q000628:therapy; D007677:Kidney Function Tests; D016030:Kidney Transplantation; D008297:Male; D006435:Renal Dialysis; D016896:Treatment Outcome
chemical_list: D019382:Human Growth Hormone