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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

growth hormone

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic focused on measuring end stage renal disease, rare disease, renal and genitourinary disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Vanderbilt University Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004429

First Posted

October 18, 1999

Last Updated

March 24, 2015

Sponsor

FDA Office of Orphan Products Development

Collaborators

Vanderbilt University

1. Study Identification

Unique Protocol Identification Number

NCT00004429

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Completed

Study Start Date

December 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

FDA Office of Orphan Products Development

Collaborators

Vanderbilt University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Failure, Chronic

Keywords

end stage renal disease, rare disease, renal and genitourinary disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

growth hormone

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Talat Alp Ikizler

Organizational Affiliation

Vanderbilt University Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-2516

Country

United States

Kidney Failure, Chronic

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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