Randomized Study of Recombinant Human Growth Hormone in Patients on Chronic Hemodialysis or Peritoneal Dialysis
I. Assess the clinical safety and long term effects of recombinant human growth hormone on a defined range of nutritional indices in malnourished chronic hemodialysis and continuous ambulatory peritoneal dialysis patients.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Study Start Date:||December 1999|
|Study Completion Date:||February 2005|
PROTOCOL OUTLINE: This is a randomized, double blind, placebo-controlled, cross-over study.
Prior to randomization each patient's protein and calorie intake is assessed and optimized as possible. Patients are randomized to receive either placebo or recombinant human growth hormone subcutaneously every other day for 6 months. At the end of this 6 month period, patients undergo a 4 week washout period. After the washout period, patients are crossed-over to the alternate regimen for an additional 6 months followed by another 4 week washout period.
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232-2516|
|Study Chair:||Talat Alp Ikizler||Vanderbilt University|