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

End Stage Renal Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004340
• Other study ID #: 199/11899
• Secondary ID: UCLA-612
• Status: Completed
• Phase: Phase 2
• First received: October 18, 1999
• Last updated: June 23, 2005
• Start date: June 1995

Study information

• Verified date: April 2002
• Source: National Center for Research Resources (NCRR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Osteodystrophy

Intervention

Drug:
• calcitriol

• growth hormone

Locations

Country	Name	City	State
United States	University of California Los Angeles School of Medicine	Los Angeles	California

Sponsors (3)

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

Country where clinical trial is conducted

United States,