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NCT02278562 · ClinicalTrials.gov registry record · Phase 2
Nutrition, Inflammation and Insulin Resistance in End Stage Renal Disease-Aim 2
A Phase 2 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
NCT02278562: Completed Phase 2 study, sponsored by VA Office of Research and Development.
NCT02278562 is a Phase 2 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 33 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02278562, a Phase 2 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
Study Summary
By 2030 an estimated 2 million people in the US will need dialysis or transplantation for advanced kidney failure. An even more disturbing statistic is that mortality in End Stage Renal Disease (ESRD) is six times higher than in the general Medicare population with adjustment for age, gender and ethnicity. Protein energy wasting is highly prevalent in these patients and is one of the most important determinants of their poor clinical outcome. Despite its well-recognized occurrence, the etiology and the mechanisms leading to protein energy wasting observed in chronic hemodialysis patients cannot be attributed to any single factor. However, irrespective of the specific etiologic mechanisms, it appears that the common pathway for all the metabolic derangements is related to exaggerated protein degradation relative to protein synthesis (47). Two well-recognized and presumably interrelated metabolic abnormalities, insulin resistance and chronic inflammation, may be the major determinants of protein catabolism in coronary heart disease (CHD) patients. There are no studies examining the effects of anti-inflammatory interventions and/or insulin sensitizers on protein homeostasis in CHD. Due to their established anti-inflammatory and other pleiotropic effects, Interleukin-1 receptor antagonist Anakinra and insulin sensitizer peroxisome proliferator-activated receptors (PPAR) agonist Actos represent two such promising interventions. By modulating inflammatory response and insulin signaling through two pharmacological interventions, the investigators will have the unique opportunity to clarify mechanisms contributing of these two particular metabolic derangements in the development of protein energy wasting observed in chronic hemodialysis patients. The overall goal is to elucidate the mechanisms by which chronic inflammation and insulin resistance influence the development of protein energy wasting in hemodialysis patients. Specific Aim: To test the hypothesis that inhibi
Interventions
- OTHER placebo
- DRUG anakinra
- DRUG actos
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2014-10-22 |
| Est. Completion | 2017-03-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02278562
The ClinicalTrials.gov registry entry for NCT02278562 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT02278562 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02278562 about?
NCT02278562 is a clinical study titled "Nutrition, Inflammation and Insulin Resistance in End Stage Renal Disease-Aim 2". By 2030 an estimated 2 million people in the US will need dialysis or transplantation for advanced kidney failure. An even more disturbing statistic is that mortality in End Stage Renal Disease (ESRD) is six times higher than in the general Medicare population with adjustment for age, gender and eth...
What is the current status of trial NCT02278562?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2014-10-22. Estimated completion is 2017-03-01.
What interventions are being tested in trial NCT02278562?
The interventions under investigation include: placebo (OTHER), anakinra (DRUG), actos (DRUG).
Who is sponsoring clinical trial NCT02278562?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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