Completed

Recombinant Human Growth Hormone and Calcitriol Effects on Children and Adolescents on Maintenance Dialysis

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

calcitriol

+ growth hormone

Drug
Who is being recruted

Avitaminosis+28

+ Bone Diseases

+ Bone Diseases, Metabolic

From 1 to 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 1995
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 1995

Actual date on which the first participant was enrolled.

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.

NCT00004340
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

109 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AvitaminosisBone DiseasesBone Diseases, MetabolicCalcium Metabolism DisordersChronic DiseaseDeficiency DiseasesEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsHyperparathyroidismHyperparathyroidism, SecondaryKidney DiseasesMetabolic DiseasesMusculoskeletal DiseasesNutrition DisordersNutritional and Metabolic DiseasesParathyroid DiseasesPathologic ProcessesRicketsPathological Conditions, Signs and SymptomsUrologic DiseasesVitamin D DeficiencyDisease AttributesMalnutritionRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesUrogenital DiseasesKidney Failure, ChronicChronic Kidney Disease-Mineral and Bone DisorderRare Diseases

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of California Los Angeles School of Medicine

Los Angeles, United StatesOpen University of California Los Angeles School of Medicine in Google Maps
CompletedOne Study Center
Recombinant Human Growth Hormone and Calcitriol Effects on Children and Adolescents on Maintenance Dialysis | PatLynk