| Trial ID: | L0633 |
| Source ID: | NCT00420290
|
| Associated Drug: |
Kineret
|
| Title: |
Inflammation, Proteolysis and IL-1 Beta Receptor Inhibition in Chronic Hemodialysis Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00420290/results
|
| Conditions: |
End Stage Renal Disease
|
| Interventions: |
DRUG: kineret|DRUG: placebo
|
| Outcome Measures: |
Primary: High Sensitivity C-reactive Protein (hsCRP), hsCRP is a sensitive laboratory assay for serum levels of C-reactive protein, which is a biomarker of inflammation., month 1 | Secondary: Interleukin-6 (IL-6), IL-6 is a sensitive laboratory assay for serum levels of interlukin-6, which is a pro-inflammatory cytokine that is used to evaluate the inflammatory response., month 1|Serum Prealbumin, Prealbumin is a sensitive laboratory assay for serum levels of prealbumin, which is a biomarker of nutrition., month 1|Serum Albumin, Albumin is a sensitive laboratory assay for serum levels of albumin, which is a biomarker of nutrition., month 1|Lean Body Mass (LBM), LBM is a measurement of body composition in terms of lean body mass as determined using Dual Energy X-ray Absorptiometry (DEXA) performed 1 to 2 hours after dialysis., month 1
|
| Sponsor/Collaborators: |
Sponsor: Vanderbilt University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
31
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-01
|
| Completion Date: |
2010-05
|
| Results First Posted: |
2011-11-17
|
| Last Update Posted: |
2011-11-17
|
| Locations: |
Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00420290
|
