Partners Calciphylaxis Biobank

NCT03032835 | Recruiting

• 1 other identifier: 2016P002690
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

Calciphylaxis; Warfarin; Dialysis

Outcome Measures

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.

  6 months

Secondary Outcomes (2)

• Number of patients with >30% improvement in pain severity

  4weeks

• Time to death in patients with calciphylaxis

  Up to 5 years

Study Arms (1)

Study participants

No intervention

Eligibility Criteria

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

Study Population

Patients with skin lesions consistent with calciphylaxis

You may qualify if:

• Male or female ≥18 years old
• Skin lesions consistent with calciphylaxis diagnosis as determined by the treating clinician
• 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

You may not qualify if:

• Patients \<18 years of age
• Prisoners

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 28049648 BACKGROUND

• 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.

  PMID: 27080977 BACKGROUND

• 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.

  PMID: 25960299 BACKGROUND

• 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.

  PMID: 36712824 DERIVED

Related Links

• Link to publications

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, DNA and tissue samples (e.g. skin)

MeSH Terms

Conditions

Calciphylaxis; Kidney Failure, Chronic; Renal Insufficiency, Chronic

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

• Sagar U Nigwekar, MD, MMSc

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sagar U Nigwekar, MD, MMSc

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Medicine

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: January 26, 2017
• Study Start: January 1, 2017
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)