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Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis

Primary Purpose

Renal Osteodystrophy, End Stage Renal Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
calcitriol
growth hormone
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Osteodystrophy focused on measuring end stage renal disease, rare disease, renal and genitourinary disorders, renal osteodystrophy

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- End-stage renal disease undergoing continuous cycling peritoneal dialysis at the University of California at Los Angeles --Prior/Concurrent Therapy-- No concurrent prednisone No concurrent cytotoxic agents At least 12 months since parathyroidectomy --Patient Characteristics-- Other: No documented history of poor compliance with medical treatment regimens

Sites / Locations

  • University of California Los Angeles School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 18, 1999
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT00004340
Brief Title
Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2002
Overall Recruitment Status
Completed
Study Start Date
June 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, Los Angeles

4. Oversight

5. Study Description

Brief Summary
OBJECTIVES: I. Evaluate the separate and combined skeletal effects of recombinant human growth hormone (GH) and calcitriol in patients with adynamic renal osteodystrophy. II. Assess whether calcium-regulated changes in parathyroid hormone secretion predict changes in bone formation. III. Characterize the response to GH in cancellous bone and in growth plate cartilage in patients with secondary hyperparathyroidism during calcitriol therapy.
Detailed Description
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by bone lesion turnover and secondary hyperparathyroidism. Patients in the first group are treated with recombinant human growth hormone subcutaneously every day for 8 months. Patients in the second group are treated with calcitriol for 8 months, administered as a daily oral dose or an intraperitoneal dose three times a week. Patients in the third group are treated with growth hormone and calcitriol (same dosages as above). A control group does not receive any hormonal therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Osteodystrophy, End Stage Renal Disease
Keywords
end stage renal disease, rare disease, renal and genitourinary disorders, renal osteodystrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
109 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
calcitriol
Intervention Type
Drug
Intervention Name(s)
growth hormone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- End-stage renal disease undergoing continuous cycling peritoneal dialysis at the University of California at Los Angeles --Prior/Concurrent Therapy-- No concurrent prednisone No concurrent cytotoxic agents At least 12 months since parathyroidectomy --Patient Characteristics-- Other: No documented history of poor compliance with medical treatment regimens
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isidro B. Salusky
Organizational Affiliation
University of California, Los Angeles
Official's Role
Study Chair
Facility Information:
Facility Name
University of California Los Angeles School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis

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