Anti-Interleukin-6 (IL6) in Calciphylaxis

Conditions

• Calciphylaxis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tocilizumab — DRUG
  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.

Study Details

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.

Key Dates

First listed

Jul 16, 2026

Start date

Sep 30, 2027

Status verified

Jul 2026

Primary completion

Mar 31, 2030

Completion

Jun 30, 2030

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Tocilizumab group
  Participants will receive a total of 3 doses of intravenous tocilizumab. One does will be administered every 4 weeks.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability [ Time Frame: weekly for 18 weeks ]

Central Contacts

• Vipul Chitalia, MD PhD
  617-638-7343
  [email protected]
• Saran Lotfollahzadeh, PhD
  [email protected]

Locations (1)

Find similar trials in Boston, MA

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