---
title: Anti-Cytokine Therapy for Hemodialysis InflammatION
nct_id: NCT03141983
overall_status: COMPLETED
phase: PHASE2
sponsor: University of Pennsylvania
study_type: INTERVENTIONAL
primary_condition: End-Stage Renal Disease
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03141983.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03141983"
ct_last_update_post_date: 2023-03-14
last_seen_at: "2026-05-12T06:20:04.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Anti-Cytokine Therapy for Hemodialysis InflammatION

**Official Title:** Anti-Cytokine Therapy for Hemodialysis InflammatION (ACTION): 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

**NCT ID:** [NCT03141983](https://clinicaltrials.gov/study/NCT03141983)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 80
- **Lead Sponsor:** University of Pennsylvania
- **Collaborators:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- **Conditions:** End-Stage Renal Disease
- **Start Date:** 2017-12-15
- **Completion Date:** 2021-09-02
- **CT.gov Last Update:** 2023-03-14

## Brief 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.

## Detailed Description

The ACTION Trial will enroll 80 participants being treated with maintenance hemodialysis for end-stage renal disease. Participants will be randomized to receive Anakinra, 100 mg administered intravenously 3 times per week at the end of the hemodialysis session, or matched placebo. The duration of study drug administration is 24 weeks. There will be an additional 24 weeks of follow-up after study drug administration has been completed.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Maintenance hemodialysis therapy 3 times per week for end-stage renal disease
2. ≥6 months since hemodialysis initiation
3. C-reactive protein measured by high sensitivity assay (hsCRP) ≥2.0 mg/L at screening and within 10 days prior to randomization
4. Most recent single pool Kt/V \> or = 1.2 within 30 days prior to first screening visit
5. 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.
6. 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.
7. 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.
8. Ability to provide informed consent

Exclusion Criteria:

1. Current or anticipated use of a hemodialysis central venous catheter
2. 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)
3. Hospitalization within 30 days unless for vascular access procedure
4. Cirrhosis
5. Malignancy within the past 5 years with exception of basal or squamous cell carcinoma
6. 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)
7. 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
8. Absolute neutrophil count (ANC) \<2,500 cells/mm3 (2.5 x 109 cells/L)
9. Platelet count \<100,000/mm3 (100 x 109/L)
10. Known allergy to anakinra
11. Anticipated kidney transplantation, change to peritoneal dialysis, or transfer to another dialysis unit within 9 months
12. Expected survival less than 9 months
13. Pregnancy, anticipated pregnancy, or breastfeeding
14. Incarceration
15. Receipt of an investigational drug within the past 30 days
16. Current or anticipated participation in another intervention study
```

## Arms

- **Anakinra** (ACTIVE_COMPARATOR) — Anakinra (Kineret®) is a therapeutic agent that blocks the effects of IL-1 alpha and IL-1 beta by competitively binding to the interleukin-1 type I receptor (IL-1RI). Anakinra is a recombinant, non-glycosylated form of the naturally occurring human interleukin-1 receptor antagonist (IL-1Ra).

Anakinra will be supplied in pre-filled syringes as a sterile, clear, colorless-to-white, preservative free solution. Each syringe will contain 100 mg in 0.67 ml solution (pH 6.5) containing disodium EDTA (0.12 mg), sodium chloride (5.48 mg), sodium citrate (1.29 mg), and polysorbate 80 (0.70 mg) in Water for Injection, USP.
- **Placebo** (PLACEBO_COMPARATOR) — Saline (0.9%) will be used as the placebo, supplied in pre-filled syringes as a sterile, clear, colorless-to-white, preservative free solution.

## Interventions

- **Anakinra** (DRUG) — Anakinra (Kineret®) is a therapeutic agent that blocks the effects of IL-1α and IL-1β by competitively binding to the interleukin-1 type I receptor (IL-1RI). It is a recombinant, non-glycosylated form of the naturally occurring human interleukin-1 receptor antagonist (IL-1Ra) but differs from human IL-1Ra in that it has the addition of a single methionine residue at the amino terminus. It is supplied commercially in single use 1 ml prefilled glass syringes as a sterile, clear, colorless-to-white, preservative free solution. Each syringe contains: 0.67 ml (100 mg) of anakinra in a solution (pH 6.5) containing sodium citrate (1.29 mg), sodium chloride (5.48 mg), disodium EDTA (0.12 mg) and polysorbate 80 (0.70 mg) in Water for Injection, USP.
- **Placebo** (DRUG) — Saline (0.9%) will be used as the placebo, in single use 1 ml prefilled glass syringes as a sterile, clear, colorless-to-white, preservative free solution.

## Primary Outcomes

- **Safety and Tolerability of Anakinra, for Patients Receiving Maintenance Hemodialysis** _(time frame: 48 Weeks (after the 24-week treatment period and the 24-week post-treatment period))_ — The primary safety endpoint is serious adverse events per patient-year.
- **Change in Log-transformed Circulating CRP Concentration After 24 Weeks of Treatment for Patients Receiving Maintenance Hemodialysis** _(time frame: Change from Baseline to 24 Weeks (end of treatment phase))_ — For this outcome, CRP measurements from Baseline and Week 24 were compared.

## Secondary Outcomes

- **Number of Participants With Adverse Events That Preclude Further Treatment With the Study Agent** _(time frame: 24-week treatment period)_
- **Safety and Tolerability of Anakinra, for Patients Receiving Maintenance Hemodialysis - Infections** _(time frame: 48 weeks)_
- **Safety and Tolerability of Anakinra, for Patients Receiving Maintenance Hemodialysis - Neutropenia** _(time frame: 48 weeks)_
- **Safety and Tolerability of Anakinra, for Patients Receiving Maintenance Hemodialysis - Thrombocytopenia** _(time frame: 48 weeks)_
- **Safety and Tolerability of Anakinra, for Patients Receiving Maintenance Hemodialysis - Systemic Hypersensitivity Reactions** _(time frame: 48 weeks)_
- **Change in Markers of Inflammation and Oxidative Stress - IL-1β pg/ml** _(time frame: change after 24 weeks of treatment)_
- **Change in Markers of Inflammation and Oxidative Stress - IL-6, pg/mL** _(time frame: change after 24 weeks of treatment)_
- **Change in Markers of Inflammation and Oxidative Stress - IL-10, pg/mL** _(time frame: change after 24 weeks of treatment)_
- **Change in Markers of Inflammation and Oxidative Stress - TNF Alpha, pg/ml** _(time frame: change after 24 weeks of treatment)_
- **Change in Markers of Inflammation and Oxidative Stress - Albumin, g/dL** _(time frame: change after 24 weeks of treatment)_
- **Change in Patient-reported Indicators of Fatigue After 24 Weeks of Treatment** _(time frame: 24 Weeks (end of treatment phase))_
- **Change in Patient-reported Indicators of Depression After 24 Weeks of Treatment for Patients Receiving Maintenance Hemodialysis** _(time frame: 24 Weeks (end of treatment phase))_
- **Change in Burden of Patient-reported Symptoms After 24 Weeks of Treatment for Patients Receiving Maintenance Hemodialysis** _(time frame: Change after 24 weeks of treatment)_
- **Change in Severity of Patient-reported Symptoms After 24 Weeks of Treatment for Patients Receiving Maintenance Hemodialysis** _(time frame: 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** _(time frame: 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** _(time frame: 24 Weeks (end of treatment phase))_

## Locations (4)

- The George Washington University, Washington D.C., District of Columbia, United States
- Brigham & Women's Hospital, Boston, Massachusetts, United States
- Vanderbilt University Medical Center, Nashville, Tennessee, United States
- University of Washington Kidney Research Institute, Seattle, Washington, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the george washington university|washington d.c.|district of columbia|united states` — added _(2026-05-12)_
- `locations.brigham & women's hospital|boston|massachusetts|united states` — added _(2026-05-12)_
- `locations.vanderbilt university medical center|nashville|tennessee|united states` — added _(2026-05-12)_
- `locations.university of washington kidney research institute|seattle|washington|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03141983.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03141983*  
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