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

This study has been completed.
Sponsor:
Collaborator:
Vanderbilt University
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004429
First received: October 18, 1999
Last updated: October 1, 2007
Last verified: October 2007

October 18, 1999
October 1, 2007
December 1999
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Complete list of historical versions of study NCT00004429 on ClinicalTrials.gov Archive Site
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Randomized Study of Recombinant Human Growth Hormone in Patients on Chronic Hemodialysis or Peritoneal Dialysis
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OBJECTIVES:

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.

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.

Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Kidney Failure, Chronic
Drug: growth hormone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
February 2005
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PROTOCOL ENTRY CRITERIA:

--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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004429
199/13377, VUMC-FDR000943
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FDA Office of Orphan Products Development
Vanderbilt University
Study Chair: Talat Alp Ikizler Vanderbilt University
FDA Office of Orphan Products Development
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP