European Calciphylaxis Registry Network

NCT02635373 | Unknown

• 1 other identifier: 13-093
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Observational, registry, prospective, non-interventional collection of CUA patient data. Patient treatment is carried out within clinical routine, at the discretion of the physicians and according to existing treatment guidelines. Participating physicians will not be subject to any instructions with regard to the diagnosis and therapy of their patients.

Conditions

Calcific Uremic Arteriolopathy (CUA); Calciphylaxis

Keywords

Calciphylaxis; Rare disease (ORPHA280062); Renal insufficiency; ESRD; Calcification; Chronic kidney disease; Dialysis; Vascular disease

Outcome Measures

Primary Outcomes (1)

• Prognosis of patients with calciphylaxis (survival time)

  Survival time is defined as 1) time between diagnosis of calciphylaxis and death (or end of follow-up) or 2) - in case time of diagnosis is not recorded - time between registry recording and death (or end of follow-up). Analysis of survival time is done using the Kaplan-Meier survival analysis and Kaplan-Meier plot. With a Cox hazard model, we will try to identify additional factors influencing survival time. Hereby it is possible to take into consideration interaction between the parameters.

  5 years

Secondary Outcomes (4)

• Diagnosis of calciphylaxis

  5 years

• Risk factors

  5 years

• Factors influencing prognosis of patients with calciphylaxis

  5 years

• Novel therapeutic options

  5 years

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 diagnosed CUA

You may qualify if:

• diagnosed CUA according to the judgement of locally treating physicians, who have the option to ask for external diagnostic advice from the country-specific sub-investigators
• Male or female aged \> 18 years
• Written informed consent prior to study participation
• The subject is not mentally or legally incapacitated

You may not qualify if:

• The subject is not able to give informed consent

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

Related Publications (14)

• Weenig RH. Pathogenesis of calciphylaxis: Hans Selye to nuclear factor kappa-B. J Am Acad Dermatol. 2008 Mar;58(3):458-71. doi: 10.1016/j.jaad.2007.12.006. Epub 2008 Jan 18.

  PMID: 18206262 BACKGROUND

• Brandenburg VM, Cozzolino M, Ketteler M. Calciphylaxis: a still unmet challenge. J Nephrol. 2011 Mar-Apr;24(2):142-8. doi: 10.5301/jn.2011.6366.

  PMID: 21337312 BACKGROUND

• Meissner M, Gille J, Kaufmann R. Calciphylaxis: no therapeutic concepts for a poorly understood syndrome? J Dtsch Dermatol Ges. 2006 Dec;4(12):1037-44. doi: 10.1111/j.1610-0387.2006.06127.x. English, German.

  PMID: 17176411 BACKGROUND

• Hafner J, Keusch G, Wahl C, Sauter B, Hurlimann A, von Weizsacker F, Krayenbuhl M, Biedermann K, Brunner U, Helfenstein U. Uremic small-artery disease with medial calcification and intimal hyperplasia (so-called calciphylaxis): a complication of chronic renal failure and benefit from parathyroidectomy. J Am Acad Dermatol. 1995 Dec;33(6):954-62. doi: 10.1016/0190-9622(95)90286-4.

  PMID: 7490365 BACKGROUND

• Mazhar AR, Johnson RJ, Gillen D, Stivelman JC, Ryan MJ, Davis CL, Stehman-Breen CO. Risk factors and mortality associated with calciphylaxis in end-stage renal disease. Kidney Int. 2001 Jul;60(1):324-32. doi: 10.1046/j.1523-1755.2001.00803.x.

  PMID: 11422768 BACKGROUND

• Janigan DT, Hirsch DJ, Klassen GA, MacDonald AS. Calcified subcutaneous arterioles with infarcts of the subcutis and skin ("calciphylaxis") in chronic renal failure. Am J Kidney Dis. 2000 Apr;35(4):588-97. doi: 10.1016/s0272-6386(00)70003-5.

  PMID: 10739777 BACKGROUND

• Kramann R, Brandenburg VM, Schurgers LJ, Ketteler M, Westphal S, Leisten I, Bovi M, Jahnen-Dechent W, Knuchel R, Floege J, Schneider RK. Novel insights into osteogenesis and matrix remodelling associated with calcific uraemic arteriolopathy. Nephrol Dial Transplant. 2013 Apr;28(4):856-68. doi: 10.1093/ndt/gfs466. Epub 2012 Dec 6.

  PMID: 23223222 BACKGROUND

• Fine A, Zacharias J. Calciphylaxis is usually non-ulcerating: risk factors, outcome and therapy. Kidney Int. 2002 Jun;61(6):2210-7. doi: 10.1046/j.1523-1755.2002.00375.x.

  PMID: 12028462 BACKGROUND

• Weenig RH, Sewell LD, Davis MD, McCarthy JT, Pittelkow MR. Calciphylaxis: natural history, risk factor analysis, and outcome. J Am Acad Dermatol. 2007 Apr;56(4):569-79. doi: 10.1016/j.jaad.2006.08.065. Epub 2006 Dec 1.

  PMID: 17141359 BACKGROUND

• Brandenburg VM, Floege J, Ketteler M. Kalzifizierende urämische Arteriolopathie. Der Nephrologe 2009; 4(1):65-66

  BACKGROUND

• Krueger T, Westenfeld R, Schurgers L, Brandenburg V. Coagulation meets calcification: the vitamin K system. Int J Artif Organs. 2009 Feb;32(2):67-74. doi: 10.1177/039139880903200202.

  PMID: 19363777 BACKGROUND

• Jahnen-Dechent W, Schafer C, Ketteler M, McKee MD. Mineral chaperones: a role for fetuin-A and osteopontin in the inhibition and regression of pathologic calcification. J Mol Med (Berl). 2008 Apr;86(4):379-89. doi: 10.1007/s00109-007-0294-y. Epub 2007 Dec 15.

  PMID: 18080808 BACKGROUND

• Cranenburg EC, Vermeer C, Koos R, Boumans ML, Hackeng TM, Bouwman FG, Kwaijtaal M, Brandenburg VM, Ketteler M, Schurgers LJ. The circulating inactive form of matrix Gla Protein (ucMGP) as a biomarker for cardiovascular calcification. J Vasc Res. 2008;45(5):427-36. doi: 10.1159/000124863. Epub 2008 Apr 10.

  PMID: 18401181 BACKGROUND

• Schafer C, Heiss A, Schwarz A, Westenfeld R, Ketteler M, Floege J, Muller-Esterl W, Schinke T, Jahnen-Dechent W. The serum protein alpha 2-Heremans-Schmid glycoprotein/fetuin-A is a systemically acting inhibitor of ectopic calcification. J Clin Invest. 2003 Aug;112(3):357-66. doi: 10.1172/JCI17202.

  PMID: 12897203 BACKGROUND

MeSH Terms

Conditions

Calciphylaxis; Rare Diseases; Renal Insufficiency; Kidney Failure, Chronic; Calcinosis; Renal Insufficiency, Chronic; Vascular Diseases

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Cardiovascular Diseases

Central Study Contacts

Vincent Brandenburg, MD, Prof.

CONTACT

+49 (0)241/80; calciphylaxis@ukaachen.de

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: December 18, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 14, 2016

Record last verified: 2016-10

Locations

DE (1)