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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: June 24, 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)
  Purpose

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.


Condition Intervention Phase
Renal Osteodystrophy End Stage Renal Disease Drug: calcitriol Drug: growth hormone Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment: 109
Study Start Date: June 1995
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004340


Locations
United States, California
University of California Los Angeles School of Medicine
Los Angeles, California, United States, 90095
Sponsors and Collaborators
National Center for Research Resources (NCRR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of California, Los Angeles
Investigators
Study Chair: Isidro B. Salusky University of California, Los Angeles
  More Information

ClinicalTrials.gov Identifier: NCT00004340     History of Changes
Other Study ID Numbers: 199/11899
UCLA-612
First Submitted: October 18, 1999
First Posted: October 19, 1999
Last Update Posted: June 24, 2005
Last Verified: April 2002

Keywords provided by National Center for Research Resources (NCRR):
end stage renal disease
rare disease
renal and genitourinary disorders
renal osteodystrophy

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Chronic Kidney Disease-Mineral and Bone Disorder
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hyperparathyroidism, Secondary
Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases
Hormones
Calcitriol
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins