Three Times Weekly (TIW) Growth Hormone Therapy in Children on Hemodialysis
Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
Hypotheses:
1. The provision of thrice weekly subcutaneous (SQ) recombinant growth hormone (rGH)
therapy to children receiving in-center hemodialysis (HD) will result in improved
growth.
2. The provision of thrice weekly SQ rGH therapy to children receiving in-center HD will
result in improved lean body mass, nutritional status and quality of life.
TIW rGH treatment regimen (0.35 mg/kg/week divided into 3 doses, each dose being given at the
conclusion of the dialysis treatment) for up to 2 years; growth response, Dual energy X-ray
absorptiometry (DEXA), and quality of life (QOL) will be measured. The goal is to enroll 20
children who are Tanner 1 with decreased height SDS and/or decreased height velocity standard
deviation scoreS (SDS).
If this therapy is demonstrated to be efficacious and improves growth and QOL, this therapy
could be easily implemented for all eligible children on HD, since parental acceptance should
be better without having to administer the rGH at home and compliance for the child will be
assured.
The investigators thus propose an important study that has the ability to advance their
understanding and provide evidence for the best methods to promote growth in children on
dialysis. The results of this study will result in important information that will be of
value to the entire pediatric nephrologist community, including health care professionals,
patients, and families. In a real sense, this study will build on the 2006 Consensus
Conference guidelines for evaluation and treatment of growth failure in children with chronic
kidney disease (CKD). This will provide evidence for critical management decisions that can
help insure better growth opportunities to more children with CKD.