CalciphylaxisPhase 1NCT07708038
Anti-Interleukin-6 (IL6) in Calciphylaxis
A Phase 1 study testing Tocilizumab in people with Calciphylaxis, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calciphylaxis
- What is being tested?
- Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2027to Jun 2030
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saran Lotfollahzadeh, PhD contact
About this study
Official title: 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.
- Conditions
- Calciphylaxis
- Being tested
- Tocilizumab
- Keywords
- chronic kidney disease (CKD), end-stage kidney disease (ESKD)
- Medical subject headings
- Calciphylaxis, Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
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 group | Role | What they receive |
|---|---|---|
| Tocilizumab group | Experimental | Participants will receive a total of 3 doses of intravenous tocilizumab. One does will be administered every 4 weeks. Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: weekly for 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study startSep 2027 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CalciphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This as a pilot feasibility and short-term safety phase 1 study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vipul Chitalia, MD PhD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708038
- Sponsor's protocol ID
- H-46722
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No