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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:
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)
ClinicalTrials.gov Identifier:
NCT00004340
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: April 2002
History of Changes

October 18, 1999
June 23, 2005
June 1995
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Complete list of historical versions of study NCT00004340 on ClinicalTrials.gov Archive Site
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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
Both
1 Year to 18 Years
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