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NCT00420290 · ClinicalTrials.gov registry record · NA
Inflammation, Proteolysis and IL-1 Beta Receptor Inhibition in Chronic Hemodialysis Patients
A NA study of End Stage Renal Disease, sponsored by Vanderbilt University.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT00420290: Completed NA study of End Stage Renal Disease, sponsored by Vanderbilt University.
NCT00420290 is a NA study of End Stage Renal Disease that has completed, run by Vanderbilt University. The registered enrollment target is 31 participants, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00420290, a NA study of End Stage Renal Disease, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
Chronic hemodialysis (CHD) patients display multiple metabolic abnormalities related to advanced uremia. Despite vigorous attempts to prevent these abnormalities and their consequences, most CHD patients suffer from a unique form of nutritional derangement, which can be termed as "uremic wasting". Several studies have demonstrated that the presence of uremic wasting, especially the degree of loss of muscle mass, sharply increases mortality and hospitalization rate in CHD patients. Several factors have been thought to be associated with uremic wasting, including hormonal derangement, anorexia, physical inactivity, and concurrent illnesses. Chronic inflammation, also highly prevalent in these patients, causes muscle catabolism in animal models and certain clinical conditions. Epidemiological studies show an association between chronic inflammation and uremic wasting in hemodialysis patients indicating a possible causal relationship. The cause for the activated inflammatory state in CHD patients is believed to be multi-factorial. Nevertheless, it is certainly important for the host to limit its biological activity by eliciting a stronger anti-inflammatory response, for example through the production of naturally occurring receptor antagonist. Interleukin 1 beta, one of the major pro-inflammatory cytokines has been shown to be associated with protein catabolism in several chronic disease states, including advanced uremia. A balance between interleukin 1 beta (agonist) and its naturally occurring receptor antagonist IL-1ra may play a pivotal role in controlling the inflammatory response and its consequences in this population. The overall goal of this particular grant application is to examine the short-term effects of the administration of the recombinant form of IL-1ra on 1) chronic inflammatory state and 2) protein homeostasis in chronically inflamed CHD patients. We have updated our protocol to perform an interim analysis. The interim analysis will be performed a
Primary Outcome
hsCRP is a sensitive laboratory assay for serum levels of C-reactive protein, which is a biomarker of inflammation.
Conditions Studied
Interventions
- DRUG placebo
- DRUG kineret
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2008-01 |
| Est. Completion | 2010-05 |
| Phase | NA |
What the finished NCT00420290 record still lists
NCT00420290 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (96% lower).
The record links to 1 condition, with End Stage Renal Disease appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00420290 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT00420290 about?
NCT00420290 is a clinical study titled "Inflammation, Proteolysis and IL-1 Beta Receptor Inhibition in Chronic Hemodialysis Patients". Chronic hemodialysis (CHD) patients display multiple metabolic abnormalities related to advanced uremia. Despite vigorous attempts to prevent these abnormalities and their consequences, most CHD patients suffer from a unique form of nutritional derangement, which can be termed as "uremic wasting". S...
What is the current status of trial NCT00420290?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2008-01. Estimated completion is 2010-05.
What conditions does trial NCT00420290 study?
This clinical trial studies the following conditions: End Stage Renal Disease.
What interventions are being tested in trial NCT00420290?
The interventions under investigation include: placebo (DRUG), kineret (DRUG).
Who is sponsoring clinical trial NCT00420290?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00420290 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00420290's enrollment target sits among peer trials
31 60th of 86 higher than 27 of 86 other End Stage Renal Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other End Stage Renal Disease 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.
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