| Outcome Measures: |
Primary: Safety and Tolerability of Anakinra, for Patients Receiving Maintenance Hemodialysis, The primary safety endpoint is serious adverse events per patient-year., 48 Weeks (after the 24-week treatment period and the 24-week post-treatment period)|Change in Log-transformed Circulating CRP Concentration After 24 Weeks of Treatment for Patients Receiving Maintenance Hemodialysis, For this outcome, CRP measurements from Baseline and Week 24 were compared., Change from Baseline to 24 Weeks (end of treatment phase) | Secondary: Number of Participants With Adverse Events That Preclude Further Treatment With the Study Agent, Adverse events were one measure used to assess safety and tolerability of anakinra, for patients receiving maintenance hemodialysis. This measure assessed the number of participants with adverse events that precluded further treatment with the study agent., 24-week treatment period|Safety and Tolerability of Anakinra, for Patients Receiving Maintenance Hemodialysis - Infections, 48 weeks|Safety and Tolerability of Anakinra, for Patients Receiving Maintenance Hemodialysis - Neutropenia, 48 weeks|Safety and Tolerability of Anakinra, for Patients Receiving Maintenance Hemodialysis - Thrombocytopenia, 48 weeks|Safety and Tolerability of Anakinra, for Patients Receiving Maintenance Hemodialysis - Systemic Hypersensitivity Reactions, 48 weeks|Change in Markers of Inflammation and Oxidative Stress - IL-1β pg/ml, Change in circulating markers of inflammation and oxidative stress between baseline and end of treatment, change after 24 weeks of treatment|Change in Markers of Inflammation and Oxidative Stress - IL-6, pg/mL, change after 24 weeks of treatment|Change in Markers of Inflammation and Oxidative Stress - IL-10, pg/mL, change after 24 weeks of treatment|Change in Markers of Inflammation and Oxidative Stress - TNF Alpha, pg/ml, change after 24 weeks of treatment|Change in Markers of Inflammation and Oxidative Stress - Albumin, g/dL, change after 24 weeks of treatment|Change in Patient-reported Indicators of Fatigue After 24 Weeks of Treatment, Change in patient reported outcomes using the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale from Baseline to Week 24. To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue. All participants were assessed with the same scoring system., 24 Weeks (end of treatment phase)|Change in Patient-reported Indicators of Depression After 24 Weeks of Treatment for Patients Receiving Maintenance Hemodialysis, Change in patient reported outcomes using the Beck Depression Inventory - II (BDI-II) scale at baseline, Weeks 12, 24 and 28. The instrument uses a 21-item self-report inventory measuring the severity of depression in adolescents and adults.The standard cut-offs are as follows: 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms., 24 Weeks (end of treatment phase)|Change in Burden of Patient-reported Symptoms After 24 Weeks of Treatment for Patients Receiving Maintenance Hemodialysis, Mean change in patient reported outcomes using the Dialysis Symptom Index, Burden subscale The DSI is a 30-question instrument assessing whether participants report a particular symptom during the past week and the severity of that symptom. Symptom burden is assessed using 30 "yes/no" questions. The scale is a count of the number of "yes" responses. The minimum is 0. The maximum is 30. The mean change in score after 24 weeks of treatment was measured. A lower score is better as a higher score indicates greater symptom burden., Change after 24 weeks of treatment|Change in Severity of Patient-reported Symptoms After 24 Weeks of Treatment for Patients Receiving Maintenance Hemodialysis, Change in patient reported outcomes using the Dialysis Symptom Index, Severity subscale The DSI severity subscale includes 30-questions assessing whether a symptom is present (previous outcome - burden subscale). The severity of each symptom that was reported as being present was assessed by asking patients to rate the degree to which the symptom was bothersome using a five-point Likert scale (1 = "not at all bothersome" to 5 = "bothers very much"). Higher scores indicating greater symptom severity. The minimum score is 30, the maximum score is 150. The mean change was used to measure this outcome., Change after 24 weeks of treatment|Change in Patient-reported Indicators of Quality of Life After 24 Weeks of Treatment for Patients Receiving Maintenance Hemodialysis, Change in patient reported outcomes using the Kidney Disease - Quality of Life subscale of the SF-12 (KDQOL SF-12) at baseline, Weeks 12, 24 and 28. A higher score reflects a more favorable health state. The questionnaire consists of 24 questions and the total possible score sum is 0-100. Items in the same scale are averaged to create scale scores., 24 Weeks (end of treatment phase)|Change in Measure of Muscle Strength (Hand Grip Strength) After 24 Weeks of Treatment for Patients Receiving Maintenance Hemodialysis, Change in measurement of hand grip strength using a standard dynamometer at baseline, Weeks 12, 24 and 28. This was measured in kg using the dominant hand., 24 Weeks (end of treatment phase)
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| Locations: |
The George Washington University, Washington, District of Columbia, 20037, United States|Brigham & Women's Hospital, Boston, Massachusetts, 02120, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States|University of Washington Kidney Research Institute, Seattle, Washington, 98104, United States
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