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NCT00194961 · ClinicalTrials.gov registry record · Phase 4
Effect of Growth Hormone on Leptin, Cytokines and Body Composition of Children With Growth Failure Due to Chronic Kidney Disease
A Phase 4 study, sponsored by Weill Medical College of Cornell University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT00194961: Clinical Trial Phase 4 study, sponsored by Weill Medical College of Cornell University.
NCT00194961 is a Phase 4 study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00194961, a Phase 4 study, was terminated before completion, sponsored by Weill Medical College of Cornell University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study Summary
Circulating concentrations of cytokines, such as leptin, tumor necrosis factor-alpha and interleukins 1 and 6 are increased in patients with chronic kidney disease (CKD). In light of the increasing recognition that growth hormone receptor signaling involves cytokine pathway activation, the investigators hypothesize that maladaptation of cytokine regulation in chronic kidney disease may underlie growth failure. Secondly, they hypothesize that administration of recombinant human growth hormone (rhGH) will result in growth rate stimulation in pre-pubertal children with growth impairment due to chronic kidney disease by down regulation of the cytokine pathways. This is a non-randomized open-label study to evaluate the effect of recombinant human growth hormone on biochemical/metabolic and immunologic parameters in relation to body composition pre- and post-recombinant human growth hormone therapy of pre-pubertal growth hormone naive children. The efficacy of recombinant human growth hormone to improve growth velocity in pre-pubertal children with growth failure is a secondary objective. Fifteen children are to be studied over a six month period. Each patient will serve as his/her own control. Six months of growth data prior to study is required.
Interventions
- DRUG Recombinant Human Growth Hormone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Est. Completion | 2007-12 |
| Phase | Phase 4 |
Why NCT00194961 stopped before completion
NCT00194961 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Recombinant Human Growth Hormone is the first listed.
NCT00194961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00194961 about?
NCT00194961 is a clinical study titled "Effect of Growth Hormone on Leptin, Cytokines and Body Composition of Children With Growth Failure Due to Chronic Kidney Disease". Circulating concentrations of cytokines, such as leptin, tumor necrosis factor-alpha and interleukins 1 and 6 are increased in patients with chronic kidney disease (CKD). In light of the increasing recognition that growth hormone receptor signaling involves cytokine pathway activation, the investiga...
What is the current status of trial NCT00194961?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 15 participants. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00194961?
The interventions under investigation include: Recombinant Human Growth Hormone (DRUG).
Who is sponsoring clinical trial NCT00194961?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00194961's enrollment target sits among peer trials
15 1880th of 2000 higher than 100 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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