| Trial ID: | L1522 |
| Source ID: | NCT02278562
|
| Associated Drug: |
Anakinra
|
| Title: |
Nutrition, Inflammation and Insulin Resistance in End Stage Renal Disease-Aim 2
|
| Acronym: |
INSPIRED
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02278562/results
|
| Conditions: |
ESRD
|
| Interventions: |
DRUG: anakinra|DRUG: actos|OTHER: placebo
|
| Outcome Measures: |
Primary: Change in Leucine Disposal Rate (LDR), LDR is a sensitive laboratory assessment of amino acid metabolism, baseline and 3 months | Secondary: Change in Whole-body Net Protein Balance, Whole-body net protein balance is the difference between protein synthesis (anabolism) and protein breakdown (catabolism) in the whole body, baseline and 3 months|Change in Skeletal Muscle Net Protein Balance, Skeletal muscle net protein balance is the difference between protein synthesis (anabolism) and protein breakdown (catabolism) in the skeletal muscles., baseline and 3 months
|
| Sponsor/Collaborators: |
Sponsor: VA Office of Research and Development
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
33
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-10-22
|
| Completion Date: |
2017-03-01
|
| Results First Posted: |
2018-04-02
|
| Last Update Posted: |
2025-02-06
|
| Locations: |
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN, Nashville, Tennessee, 37212-2637, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02278562
|
