Phase 2
Completed N=80
Anti-Cytokine Therapy for Hemodialysis InflammatION
Source: ClinicalTrials.gov NCT03141983 ↗Enrolled (actual)
80
Serious AEs
50.0%
Results posted
Mar 2023
Primary outcomePrimary: Safety and Tolerability of Anakinra, for Patients Receiving Maintenance Hemodialysis — 2.71; 2.74 events per patient-year
Summary
Anti-Cytokine Therapy for Hemodialysis InflammatION (ACTION) is a phase II multi-center study to evaluate the safety and tolerability of anakinra, an IL-1 receptor antagonist, for patients treated with maintenance hemodialysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of Anakinra, for Patients Receiving Maintenance Hemodialysis |
2.71; 2.74 | — |
| PRIMARY Change in Log-transformed Circulating CRP Concentration After 24 Weeks of Treatment for Patients Receiving Maintenance Hemodialysis |
-0.4; -0.2 | — |
| SECONDARY Number of Participants With Adverse Events That Preclude Further Treatment With the Study Agent |
3; 1 | — |
| SECONDARY Safety and Tolerability of Anakinra, for Patients Receiving Maintenance Hemodialysis - Infections |
5; 11 | — |
| SECONDARY Safety and Tolerability of Anakinra, for Patients Receiving Maintenance Hemodialysis - Neutropenia |
1; 0 | — |
| SECONDARY Safety and Tolerability of Anakinra, for Patients Receiving Maintenance Hemodialysis - Thrombocytopenia |
0; 0 | — |
| SECONDARY Safety and Tolerability of Anakinra, for Patients Receiving Maintenance Hemodialysis - Systemic Hypersensitivity Reactions |
1; 0 | — |
| SECONDARY Change in Markers of Inflammation and Oxidative Stress - IL-1β pg/ml |
0.0; 0.0 | — |
| SECONDARY Change in Markers of Inflammation and Oxidative Stress - IL-6, pg/mL |
-0.7; 0.0 | — |
| SECONDARY Change in Markers of Inflammation and Oxidative Stress - IL-10, pg/mL |
0.0; 0.0 | — |
| SECONDARY Change in Markers of Inflammation and Oxidative Stress - TNF Alpha, pg/ml |
-0.2; 0.0 | — |
| SECONDARY Change in Markers of Inflammation and Oxidative Stress - Albumin, g/dL |
0.0; 0.0 | — |
| SECONDARY Change in Patient-reported Indicators of Fatigue After 24 Weeks of Treatment |
-4.9; -0.4 | — |
| SECONDARY Change in Patient-reported Indicators of Depression After 24 Weeks of Treatment for Patients Receiving Maintenance Hemodialysis |
-0.9; -0.1 | — |
| SECONDARY Change in Burden of Patient-reported Symptoms After 24 Weeks of Treatment for Patients Receiving Maintenance Hemodialysis |
0.2; 0.3 | — |
| SECONDARY Change in Severity of Patient-reported Symptoms After 24 Weeks of Treatment for Patients Receiving Maintenance Hemodialysis |
-4.0; -0.3 | — |
| SECONDARY Change in Patient-reported Indicators of Quality of Life After 24 Weeks of Treatment for Patients Receiving Maintenance Hemodialysis |
-3.5; -3.3 | — |
| SECONDARY Change in Measure of Muscle Strength (Hand Grip Strength) After 24 Weeks of Treatment for Patients Receiving Maintenance Hemodialysis |
-0.5; -0.4 | — |
Eligibility Criteria
Inclusion Criteria
- Maintenance hemodialysis therapy 3 times per week for end-stage renal disease
- ≥6 months since hemodialysis initiation
- C-reactive protein measured by high sensitivity assay (hsCRP) ≥2.0 mg/L at screening and within 10 days prior to randomization
- Most recent single pool Kt/V > or = 1.2 within 30 days prior to first screening visit
- Negative tuberculosis interferon gamma release assay (e.g. Quantiferon-TB Gold) for tuberculosis unless documented treatment for a) positive PPD, b) positive interferon gamma release assay, or c) tuberculosis.
- Negative human immunodeficiency virus (HIV) antibody test, negative hepatitis C Ab test unless viral clearance following direct antiviral therapy is documented, and negative hepatitis B surface antigen positivity.
- For women of childbearing potential, willingness to use a highly effective method of birth control for up to 4 weeks after the last dose of anakinra.
- Ability to provide informed consent
Exclusion Criteria
- Current or anticipated use of a hemodialysis central venous catheter
- Acute bacterial infection, including vascular access infection, within 60 days prior to screening unless treated with antibiotics and resolved. Any chronic bacterial infection (e.g., osteomyelitis or bronchiectasis)
- Hospitalization within 30 days unless for vascular access procedure
- Cirrhosis
- Malignancy within the past 5 years with exception of basal or squamous cell carcinoma
- Use of an immunosuppressive drug within the past 3 months except low doses of oral corticosteroids (total daily dose ≤10 mg/day of prednisone or equivalent)
- Receipt of live vaccine within the past 3 months. Live vaccines include Varicella zoster, measles, oral polio, rotavirus, yellow fever, and the nasal spray influenza vaccine
- Absolute neutrophil count (ANC) <2, 500 cells/mm3 (2.5 x 109 cells/L)
- Platelet count <100,000/mm3 (100 x 109/L)
- Known allergy to anakinra
- Anticipated kidney transplantation, change to peritoneal dialysis, or transfer to another dialysis unit within 9 months
- Expected survival less than 9 months
- Pregnancy, anticipated pregnancy, or breastfeeding
- Incarceration
- Receipt of an investigational drug within the past 30 days
- Current or anticipated participation in another intervention study
Data sourced from ClinicalTrials.gov (NCT03141983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.