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NOT YET RECRUITING
NCT07708038
PHASE1

Anti-Interleukin-6 (IL6) in Calciphylaxis

Sponsor: Boston Medical Center

View on ClinicalTrials.gov

Summary

Calciphylaxis is a rare but incredibly dangerous condition that causes small blood vessels in the skin to become blocked by calcium buildup and blood clots. This leads to painful skin sores (necrosis) that do not heal easily. Because these open wounds are prone to severe infections, the outlook for patients is often grim; more than half of those diagnosed do not survive past the first year. Currently, there are no Food and Drug Administration (FDA) approved medications specifically designed to stop the progression of this disease. However, recent research has identified a specific culprit: Interleukin-6 (IL-6). The research team is looking at a drug called Tocilizumab to turn off the progression of the disease. This project aims to investigate whether Tocilizumab can consistently stop the cycle of inflammation and clotting, providing a much-needed lifeline for patients facing this life-threatening diagnosis. Ten participants with calciphylaxis and end-stage kidney disease will be enrolled to receive 3 infusions of Tocilizumab, follow-ups on a weekly basis, during their trip to the dialysis unit, for a total of 16 weeks.

Official title: Tocilizumab for Chronic Kidney Disease (CKD)-Associated Calciphylaxis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2027-09

Completion Date

2030-06

Last Updated

2026-07-16

Healthy Volunteers

No

Conditions

Interventions

DRUG

Tocilizumab

Tocilizumab (8 mg/kg) will be administered intravenously every 4 weeks with weekly monitoring during the participant's dialysis visit. Final assessments and safety labs will be performed 4 weeks after the last dose.

Locations (1)

Boston Medical Center

Boston, Massachusetts, United States