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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004340
First Posted: October 19, 1999
Last Update Posted: December 9, 2005
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.
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of California, Los Angeles
Information provided by:
National Center for Research Resources (NCRR)
October 18, 1999
October 19, 1999
December 9, 2005
June 1995
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No Changes Posted
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Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis
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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.

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.

Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
  • Renal Osteodystrophy
  • End Stage Renal Disease
  • Drug: calcitriol
  • 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
109
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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
Sexes Eligible for Study: All
1 Year to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00004340
199/11899
UCLA-612
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National Center for Research Resources (NCRR)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of California, Los Angeles
Study Chair: Isidro B. Salusky University of California, Los Angeles
National Center for Research Resources (NCRR)
April 2002

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