Anti-Interleukin-6 (IL6) in Calciphylaxis

NCT07708038 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: H-46722
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Calciphylaxis

Keywords

chronic kidney disease (CKD); end-stage kidney disease (ESKD)

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability

  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.

  weekly for 18 weeks

• Feasibility of treatment

  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.

  18 weeks

Secondary Outcomes (2)

• Measurement of wound regression

  weekly for 18 weeks

• Pain assessment

  weekly for 18 weeks

Study Arms (1)

Tocilizumab group

EXPERIMENTAL

Participants will receive a total of 3 doses of intravenous tocilizumab. One does will be administered every 4 weeks.

Drug: Tocilizumab

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.

Tocilizumab group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Calciphylaxis; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vipul Chitalia, MD PhD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vipul Chitalia, MD PhD

CONTACT

617-638-7343; vichitali@bu.edu

Saran Lotfollahzadeh, PhD

CONTACT

slotfoll@bu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This as a pilot feasibility and short-term safety phase 1 study

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)