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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004429
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
Vanderbilt University
Information provided by:
FDA Office of Orphan Products Development

Brief Summary:


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 or disease Intervention/treatment Phase
Kidney Failure, Chronic Drug: growth hormone Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : December 1999
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00004429     History of Changes
Other Study ID Numbers: 199/13377
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: October 2007

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