ClinicalTrials.gg
RecruitingNCT03032835PCBUpdated Sep 14, 2026

Partners Calciphylaxis Biobank

An observational study in Calciphylaxis, Calcific Uremic Arteriolopathy and End Stage Renal Disease, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Massachusetts General Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

This repository is working in collaboration with the Partners Biobank as they will still be receiving samples from the PCB and storing them and distributing them according to their own procedures.

02

Conditions studied

  • Calciphylaxis
  • Calcific Uremic Arteriolopathy
  • End Stage Renal Disease
  • Chronic Kidney Diseases

Keywords

  • Calciphylaxis
  • Warfarin
  • Dialysis
03

In context

Calciphylaxis

23 studies on the registry are indexed under Calciphylaxis; 10 are open to participants now.

This study's planned enrollment of 300 is below the median of 450 across 10 observational studies indexed under Calciphylaxis.

Browse Calciphylaxis studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with skin lesions consistent with calciphylaxis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 nature of the study and sign written OR are eligible for surrogate consent process based on impaired decision making

Exclusion criteria

Exclusion Criteria:

  1. Patients \<18 years of age
  2. Prisoners
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
20 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Study participants

    No intervention

06

What researchers measure

Primary outcomes

  1. Number of patients with improvement in calciphylaxis skin lesions

    Skin lesions will be assessed by investigators at baseline (entry into study) and at 6 months to determine whether there is improvement. The investigators will determine clinical, laboratory and genetic predictors of this outcome in calciphylaxis patients.

    Time frame: 6 months

Secondary outcomes

  1. Number of patients with >30% improvement in pain severity

    Pain severity will be assessed by investigators at baseline (entry into study) and at 4 weeks to determine whether there is improvement. Pain is measured using Wong-Baker Faces pain rating scale. The investigators will examine clinical, laboratory and genetic predictors of this outcome in calciphylaxis patients.

    Time frame: 4weeks

  2. Time to death in patients with calciphylaxis

    Time to death is defined as time from the diagnosis of calciphylaxis to death (or to the end of follow up). The investigators will examine clinical, laboratory and genetic predictors of this outcome in calciphylaxis patients.

    Time frame: Up to 5 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Nigwekar SU, Bloch DB, Nazarian RM, Vermeer C, Booth SL, Xu D, Thadhani RI, Malhotra R. Vitamin K-Dependent Carboxylation of Matrix Gla Protein Influences the Risk of Calciphylaxis. J Am Soc Nephrol. 2017 Jun;28(6):1717-1722. doi: 10.1681/ASN.2016060651. Epub 2017 Jan 3. PubMed 28049648 ↗
  • Nigwekar SU, Zhao S, Wenger J, Hymes JL, Maddux FW, Thadhani RI, Chan KE. A Nationally Representative Study of Calcific Uremic Arteriolopathy Risk Factors. J Am Soc Nephrol. 2016 Nov;27(11):3421-3429. doi: 10.1681/ASN.2015091065. Epub 2016 Apr 14. PubMed 27080977 ↗
  • Nigwekar SU, Kroshinsky D, Nazarian RM, Goverman J, Malhotra R, Jackson VA, Kamdar MM, Steele DJ, Thadhani RI. Calciphylaxis: risk factors, diagnosis, and treatment. Am J Kidney Dis. 2015 Jul;66(1):133-46. doi: 10.1053/j.ajkd.2015.01.034. Epub 2015 May 7. PubMed 25960299 ↗
  • Wen W, Krinsky S, Kroshinsky D, Durant O, He J, Seethapathy R, Hillien SAS, Mengesha B, Malhotra R, Chitalia V, Nazarian RM, Goverman J, Lyons KS, Nigwekar SU. Patient-Reported and Clinical Outcomes Among Patients With Calciphylaxis. Mayo Clin Proc Innov Qual Outcomes. 2023 Jan 24;7(1):81-92. doi: 10.1016/j.mayocpiqo.2022.12.006. eCollection 2023 Feb. PubMed 36712824 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2017, a primary completion of Dec 2030 and a completion of Dec 2030. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 23, 2017
First posted
Jan 26, 2017
Start
Jan 2017
Primary completionEst.
Dec 2030
CompletionEst.
Dec 2030
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03032835
Responsible party
Sagar U. Nigwekar, MD, MMSc (Assistant in Medicine, Massachusetts General Hospital) — Principal investigator
First posted
Jan 26, 2017
Start date
Jan 2017
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Sep 14, 2026

Study contacts

Sagar U Nigwekar, MD, MMSc
Contact
snigwekar@mgh.harvard.edu
617-726-7872
Sagar U Nigwekar, MD, MMSc
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion