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Randomized Study of Recombinant Human Growth Hormone in Patients on Chronic Hemodialysis or Peritoneal Dialysis

This study has been completed.
Vanderbilt University
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: October 18, 1999
Last updated: March 24, 2015
Last verified: October 2007


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.

Condition Intervention
Kidney Failure, Chronic Drug: growth hormone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by FDA Office of Orphan Products Development:

Enrollment: 25
Study Start Date: December 1999
Study Completion Date: February 2005
Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--Disease Characteristics--

  • On hemodialysis or peritoneal dialysis for more than 3 months
  • Optimally dialyzed (urea reduction ratio greater than 65%)
  • Suboptimal nutritional status identified by one of the following criteria: -Protein catabolic rate less than 0.85 g/kg/d calculated by three point urea kinetic modeling on at least 2 occasions over the past 6 months -Progressive unintentional weight loss of more than 2.5% of the initial or ideal body weight and/or patient weighs less than 90% of ideal body weight -Biochemical parameters of malnutrition defined by two or more of the following measurements over the past 3 months: Serum albumin no greater than 3.7 g/dL Serum transferrin concentration less than 250 mg/dL Serum prealbumin concentration less than 30 mg/dL Serum IGF-1 concentration less than 0.250 mg/mL

--Patient Characteristics--

  • No active autoimmune, inflammatory, or infectious disease At least 6 months since any documented malignancy
  • No unusual dietary restrictions At least 3 months since peritonitis
  Contacts and Locations
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Please refer to this study by its identifier: NCT00004429

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2516
Sponsors and Collaborators
FDA Office of Orphan Products Development
Vanderbilt University
Study Chair: Talat Alp Ikizler Vanderbilt University Medical Center
  More Information Identifier: NCT00004429     History of Changes
Other Study ID Numbers: 199/13377
Study First Received: October 18, 1999
Last Updated: March 24, 2015

Keywords provided by FDA Office of Orphan Products Development:
end stage renal disease
rare disease
renal and genitourinary disorders

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on August 21, 2017