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Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis
NCT00004340 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG growth hormone
- DRUG calcitriol
Study Locations (1)
California
- University of California Los Angeles School of Medicine — Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 1995-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00004340
The ClinicalTrials.gov registry entry for NCT00004340 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Center for Research Resources (NCRR), which has 20 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with End Stage Renal Disease appearing as the primary indexed condition, and to 2 interventions — of which growth hormone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00004340 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00004340 about?
NCT00004340 is a clinical study titled "Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis". 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. Character...
What is the current status of trial NCT00004340?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 1995-06.
What conditions does trial NCT00004340 study?
This clinical trial studies the following conditions: End Stage Renal Disease, Renal Osteodystrophy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00004340?
The interventions under investigation include: growth hormone (DRUG), calcitriol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00004340?
This trial is sponsored by National Center for Research Resources (NCRR), which has 20 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00004340 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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