Biomaterial Database

Growth after discontinuation of recombinant human growth hormone therapy in children with chronic renal insufficiency. The Genentech Cooperative Study Group. 1996

R N Fine, and D F Brown, and J Kuntze, and P Wooster, and E E Kohaut

Department of Pediatrics, State University of New York at Stony Brook 11794-8111, USA.

OBJECTIVE The impact of a pause in treatment with recombinant human growth hormone (rhGH) during the course of chronic renal insufficiency (CRI) once target height (50th percentile for mid-parental height) is reached and the impact of cessation of rhGH treatment after successful renal transplantation were evaluated. Prepubertal patients with CRI included in a multicenter, randomized, double-blind, placebo-controlled trial who either reached target height or received a renal transplant, or both, were included in this report. Patients in the placebo group may have initiated pubertal development at the time rhGH treatment was begun. METHODS Growth velocity (measured in centimeters per year) and standardized height score (SDS) in 22 patients who had a pause in rhGH therapy after attainment of target height were evaluated serially before and after the pause, and 30 patients, 4 of whom were also included in the pause group, who discontinued rhGH therapy at the time of transplantation were followed as long as 68 months after transplantation. RESULTS Six of twenty-two patients (two of whom subsequently underwent transplantation) continued with the pause in treatment for a mean (+/-SD) duration of 25.5 +/- 26.9 months (group 1), and 16 of 22 resumed rhGH therapy after pausing for a mean (+/-SD) of 9.0 +/- 4.6 months (group 2). The mean (+/-SD) growth velocity during the pause in group 1 was 5.1 +/- 1.8 cm/yr and in group 22.7 +/- 1.7 cm/yr. After reinstitution of rhGH in group 2, the mean (+/-SD) growth velocity increased to 7.2 +/- 1.7 cm/yr. The mean (+/-SD) height SDS in the 30 patients who discontinued rhGH therapy at the time of transplantation was -2.8 +/- 0.9 at baseline (initiation of rhGH therapy), -1.6 +/- 1.3 at the time of transplantation, and -1.7 +/- 1.2 at last follow-up. The mean (+/-SD) growth velocity was 5.1 +/- 4.7 cm/yr after transplantation, and the mean (+/-SD) delta (delta) height SDS was -0.07 +/- 0.5 at last follow-up. CONCLUSIONS A pause in rhGH treatment in children with CRI after attainment of target height leads to maintenance of height SDS in 27% and a marked reduction in growth velocity, requiring reinstitution of rhGH therapy, in 73%; discontinuing rhGH treatment at the time of transplantation does not result in substantive posttransplantation "catch down" growth.

UI	MeSH Term	Description	Entries
D007676	Kidney Failure, Chronic	The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.	ESRD,End-Stage Renal Disease,Renal Disease, End-Stage,Renal Failure, Chronic,Renal Failure, End-Stage,Chronic Kidney Failure,End-Stage Kidney Disease,Chronic Renal Failure,Disease, End-Stage Kidney,Disease, End-Stage Renal,End Stage Kidney Disease,End Stage Renal Disease,End-Stage Renal Failure,Kidney Disease, End-Stage,Renal Disease, End Stage,Renal Failure, End Stage
D008297	Male		Males
D010919	Placebos	Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol.	Sham Treatment
D011994	Recombinant Proteins	Proteins prepared by recombinant DNA technology.	Biosynthetic Protein,Biosynthetic Proteins,DNA Recombinant Proteins,Recombinant Protein,Proteins, Biosynthetic,Proteins, Recombinant DNA,DNA Proteins, Recombinant,Protein, Biosynthetic,Protein, Recombinant,Proteins, DNA Recombinant,Proteins, Recombinant,Recombinant DNA Proteins,Recombinant Proteins, DNA
D001827	Body Height	The distance from the sole to the crown of the head with body standing on a flat surface and fully extended.	Body Heights,Height, Body,Heights, Body
D002648	Child	A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL.	Children
D002675	Child, Preschool	A child between the ages of 2 and 5.	Children, Preschool,Preschool Child,Preschool Children
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260	Female		Females
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man