Anti-Interleukin-6 (IL6) in Calciphylaxis

This study is investigating Tocilizumab (a drug) for people with calciphylaxis. Calciphylaxis is a serious condition where calcium and blood clots block small blood vessels in the skin, causing painful, non-healing sores. Currently, there are no FDA-approved treatments for this condition. Researchers believe that a substance called Interleukin-6 (IL-6) plays a role in calciphylaxis, and Tocilizumab aims to target this. You may be eligible if you have a clinical diagnosis of calciphylaxis confirmed by a dermatologist or surgeon, and a skin biopsy showing specific changes. The main goal is to see how safe and tolerable Tocilizumab is, and if it's practical to give this treatment over 18 weeks.

Study design: This is an interventional study with a planned enrollment of 10 participants. The phase of the study is not specified.
What's involved: You would receive Tocilizumab intravenously every 4 weeks, with weekly monitoring during dialysis visits. Final assessments and safety labs will be done 4 weeks after your last dose.
Compensation: Not stated in the trial record.
Follow-up: Final assessments and safety labs will be performed 4 weeks after the last dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Anti-Interleukin-6 (IL6) in Calciphylaxis

Not Yet Recruiting

PHASE1Ages 18+InterventionalTreatment

Boston Medical Center

~10 participants

Updated 2026-07-16 on ClinicalTrials.gov

What's tested:Tocilizumab

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability

Measured over weekly for 18 weeks

+1 more outcome measured

Conditions

Calciphylaxis

NCT07708038

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Boston Medical Center
Boston, Massachusettsno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Vipul Chitalia, MD PhD · PRINCIPAL_INVESTIGATOR · Boston Medical Center

Who to contact

Vipul Chitalia, MD PhD

[email protected]

617-638-7343

Email the study team

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Eligibility criteria

Inclusion

Must have a clinical diagnosis of calciphylaxis (calcific uremic arteriolopathy) as determined by a board-certified dermatologist or surgeon.

Diagnosis must be supported by either:

Histopathology: A skin biopsy showing characteristic medial arteriolar calcification, subintimal fibrosis, or microvascular thrombosis.

Clinical Presentation: In cases where a biopsy is clinically contraindicated, the presence of characteristic ischemic or necrotic skin lesions in a distribution typical for calciphylaxis (e.g., adipose-rich areas like the abdomen, thighs, or buttocks).

Must have advanced kidney disease, defined as:

End-Stage Kidney Disease (ESKD): Requiring maintenance hemodialysis or peritoneal dialysis.

Chronic Kidney Disease (CKD): Stage 4 or 5 \[estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73m²\].

Participants must be able to understand and provide written informed consent. in accordance with local institutional and regulatory guidelines.

Subjects of childbearing potential must agree to use highly effective contraception for the duration of the study and for at least 3 months following the final dose of Tocilizumab.

Must be willing to undergo blood draws for systemic biomarker analysis (CRP, sTF) as outlined in the study schedule, and safety monitoring.

Exclusion

Presence of any active, clinically significant infection (bacterial, viral, fungal, or opportunistic) that, in the opinion of the investigator, would pose an unacceptable risk to the patient during IL-6 inhibition.

Known history of diverticulitis, intestinal perforation, or active gastrointestinal ulceration, due to the increased risk of GI perforation associated with tocilizumab.

Evidence of active tuberculosis (TB) or untreated latent TB \[confirmed via positive Interferon-Gamma Release Assay (IGRA) or purified protein derivative (PPD) skin test\].

Evidence of active Hepatitis B \[HBsAg positive, or HBcAb positive with detectable hepatitis B virus (HBV) DNA) or active Hepatitis C (HCV RNA positive\]

Absolute Neutrophil Count (ANC) \< 1,500 cells/mm³.

Platelet count \< 100,000 cells/mm³.

Hemoglobin \< 8.0 g/dL.

Baseline elevations of (alanine aminotransferase test (ALT) or aspartate aminotransferase test (AST) \> 1.5 times the upper limit of normal (ULN).

Known active malignancy or a history of malignancy within the last 5 years (excluding successfully treated non-melanoma skin cancer or carcinoma in situ of the cervix).

History of multiple sclerosis or other central demyelinating disorders.

Recent or planned use of other biological response modifiers (e.g., tumor necrosis factor (TNF)-alpha inhibitors, IL-1 receptor antagonists, or B-cell depleting agents) within 3 months prior to enrollment.

Receipt of a live or attenuated vaccine within 4 weeks prior to the first dose, or planned vaccination during the study period and for 4 weeks following the final dose.

Known hypersensitivity to tocilizumab or any of its excipients.

Pregnant or breastfeeding women, or those planning to become pregnant during the study period.

Individuals who are unable to provide personal informed consent and do not have a Legally Authorized Representative (LAR) available to provide consent on their behalf

Any other concurrent medical or psychiatric condition that, in the investigator's judgment, would make the subject inappropriate for the study or interfere with safety evaluations.

Prisoners

What this trial measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerabilityweekly for 18 weeks
Safety will be measured through the incidence and severity of Treatment-Emergent Adverse Events (TEAEs), graded according to the CTCAE v5.0, with focused vigilance on serious infections, gastrointestinal complications, and infusion-related hypersensitivity.
Feasibility of treatment18 weeks
Feasibility will be evaluated through specific operational metrics, including the ratio of successfully enrolled participants to those screened and the percentage of participants who complete the full 18-week study procedure schedule.

Trialytics