Anti-Interleukin-6 (IL6) in Calciphylaxis

Tocilizumab for Chronic Kidney Disease (CKD)-Associated Calciphylaxis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Calciphylaxis
• Intervention / Treatment: Drug: Tocilizumab

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Vipul Chitalia, MD PhD; Phone Number: 617-638-7343; Email: vichitali@bu.edu
• Study Contact Backup: Name: Saran Lotfollahzadeh, PhD; Email: slotfoll@bu.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tocilizumab group; Participants will receive a total of 3 doses of intravenous tocilizumab. One does will be administered every 4 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of wound regression	Quantitative measurement of the surface area (length x width) of the primary calciphylaxis lesion(s) using digital photography and standardized planimetry software will be done to track quantitative changes in ulcer surface area indicator of reduced ischemic necrosis.	weekly for 18 weeks
Pain assessment	Patient-reported Visual Analog Scale (VAS) scores for pain intensity. These intensity ratings will be cross-referenced with weekly Morphine Milligram Equivalent (MME) calculations and daily pain logbook entries to determine whether the intervention successfully reduces the overall systemic opioid burden. Higher VAS scores are associated with greater pain intensity.	weekly for 18 weeks

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Vipul Chitalia, MD PhD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: chronic kidney disease (CKD); end-stage kidney disease (ESKD)
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Renal Insufficiency; Calcium Metabolism Disorders; Calcinosis; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Calciphylaxis; tocilizumab
• Other Study ID Numbers: H-46722

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes