Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT03032835

Conditions

Calciphylaxis

Calcific Uremic Arteriolopathy

End Stage Renal Disease

Chronic Kidney Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Calciphylaxis, a vascular calcification disorder, is a rare and serious disorder characterized by calcification of dermal arterioles.

There are significant gaps in the understanding of the pathophysiology and risk factors for calciphylaxis. At present, there is no effective treatment. Uncertain pathobiology, rare incidence and lack of collaborative approach have been some of the major limiting factors towards treating calciphylaxis.

The Partners Calciphylaxis Biorepository (PCB) aims to address these gaps within calciphylaxis research by utilizing existing and, when necessary, developing new infrastructure to support the consent of patients and the collection of dedicated samples for a calciphylaxis repository.

Conditions

Calciphylaxis

Calcific Uremic Arteriolopathy

End Stage Renal Disease

Chronic Kidney Diseases

Study ID

NCT03032835

Start date

Jan, 2017

Status verified date

Sep, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female ≥18 years old
2. Skin lesions consistent with calciphylaxis diagnosis as determined by the treating clinician
3. Informed of the investigational nature of the study and sign written Informed consent OR are eligible for surrogate consent process based on impaired decision making

Exclusion Criteria:

1. Patients <18 years of age
2. Prisoners

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Study participants

No intervention

Primary outcome measure

  • Number of patients with improvement in calciphylaxis skin lesions [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Sagar U Nigwekar, MD, MMSc

617-726-7872snigwekar@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Sagar U Nigwekar, MD, MMSc

617-726-7872snigwekar@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

  • Calciphylaxis
  • Warfarin
  • Dialysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-09-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.