Evaluation of Vitamin K Supplementation for Calcific Uremic Arteriolopathy
VitK-CUA
1 other identifier
interventional
26
1 country
1
Brief Summary
Calcific uremic arteriolopathy a.k.a. calciphylaxis is a vascular calcification disorder seen in dialysis patients. Calcific uremic arteriolopathy has 60-80% one-year mortality and significant morbidity associated with non-healing and extremely painful skin lesions. At present, there is no effective treatment for calcific uremic arteriolopathy. Vitamin K is an important vitamin for inhibiting vascular calcification. It is known to increase the circulating levels of carboxylated Matrix Gla Protein, a potent inhibitor of vascular calcification. However, the effects of vitamin K supplementation in patients with calcific uremic arteriolopathy are unknown. The purpose of this study is to conduct a pilot randomized controlled trial to examine the effects of oral vitamin K supplementation on circulating levels of anti-calcification factor (carboxylated Matrix Gla Protein) and clinical outcomes in patients with calcific uremic arteriolopathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2014
CompletedFirst Posted
Study publicly available on registry
October 30, 2014
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedSeptember 17, 2019
September 1, 2019
4.4 years
October 27, 2014
September 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in circulating MGP level at 12 weeks
Baseline and 12 weeks
Secondary Outcomes (3)
Change from baseline in largest lesion size at 12 weeks
Baseline and every month for 3 months
Change from baseline in combined area of all lesions at 12 weeks
Baseline and every month for 3 months
Change from baseline in pain at 12 weeks
Baseline and every month for 3 months
Other Outcomes (1)
Adverse events
Baseline and every month for 3 months
Study Arms (2)
Vitamin K
ACTIVE COMPARATORVitamin K1 (phytonadione) 10 mg orally three times a week after dialysis for 12 weeks
Placebo
PLACEBO COMPARATORIdentical appearing placebo orally three times a week after dialysis for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Calcific uremic arteriolopathy (a.k.a. calciphylaxis)
You may not qualify if:
- Warfarin discontinuation contra-indicated (e.g. mechanical heart valve)
- Prior allergic reaction to vitamin K
- Prior history of venous thromboembolism\*
- Pregnancy and lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- National Kidney Foundation, United Statescollaborator
- American Heart Associationcollaborator
- Harvard Universitycollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (7)
Nigwekar SU, Brunelli SM, Meade D, Wang W, Hymes J, Lacson E Jr. Sodium thiosulfate therapy for calcific uremic arteriolopathy. Clin J Am Soc Nephrol. 2013 Jul;8(7):1162-70. doi: 10.2215/CJN.09880912. Epub 2013 Mar 21.
PMID: 23520041BACKGROUNDNigwekar SU, Bhan I, Turchin A, Skentzos SC, Hajhosseiny R, Steele D, Nazarian RM, Wenger J, Parikh S, Karumanchi A, Thadhani R. Statin use and calcific uremic arteriolopathy: a matched case-control study. Am J Nephrol. 2013;37(4):325-32. doi: 10.1159/000348806. Epub 2013 Mar 21.
PMID: 23548843BACKGROUNDNigwekar 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: 28049648BACKGROUNDNigwekar 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: 27080977BACKGROUNDCozzolino M, Mangano M, Galassi A, Ciceri P, Messa P, Nigwekar S. Vitamin K in Chronic Kidney Disease. Nutrients. 2019 Jan 14;11(1):168. doi: 10.3390/nu11010168.
PMID: 30646590BACKGROUNDD Shirsat P, Sonavane K, Botana LR, Sachdeva B. Calciphylaxis in the Upper GI Tract in an ESRD Patient: An Atypical Presentation and Review of Literature. Case Rep Nephrol. 2025 Dec 11;2025:3967671. doi: 10.1155/crin/3967671. eCollection 2025.
PMID: 41472909DERIVEDKrishnasamy R, Jardine MJ; BEAT-Calci Trialists. Adaptive Designs for Clinical Trials in Nephrology. J Am Soc Nephrol. 2025 Jan 1;36(1):147-149. doi: 10.1681/ASN.0000000000000497. Epub 2024 Aug 26. No abstract available.
PMID: 39186385DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sagar Nigwekar, MD, MMSc
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Physician
Study Record Dates
First Submitted
October 27, 2014
First Posted
October 30, 2014
Study Start
March 1, 2015
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
September 17, 2019
Record last verified: 2019-09