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

NCT00004340 | Completed Phase 2

• 2 other identifiers: 199/11899UCLA-612
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Osteodystrophy; End Stage Renal Disease

Keywords

end stage renal disease; rare disease; renal and genitourinary disorders; renal osteodystrophy

Interventions

calcitriol DRUG

growth hormone DRUG

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

University of California Los Angeles School of Medicine

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder; Kidney Failure, Chronic; Rare Diseases; Urogenital Diseases

Interventions

Calcitriol; Growth Hormone

Condition Hierarchy (Ancestors)

Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Isidro B. Salusky

  University of California, Los Angeles

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: June 1, 1995
• Last Updated: June 24, 2005

Record last verified: 2002-04

Locations

US (1)