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

NCT ID: NCT00004429

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-12-31
• Study Completion Date: 2005-02-28

Brief Summary

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.

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.

Conditions

Kidney Failure, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

growth hormone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: collaborator

FDA Office of Orphan Products Development

FED

Sponsor Role: lead

Principal Investigators

Talat Alp Ikizler

Role: STUDY_CHAIR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

VUMC-FDR000943

Identifier Type: -

Identifier Source: secondary_id

199/13377

Identifier Type: -

Identifier Source: org_study_id