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European Calciphylaxis Registry Network (EuCalNet)

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ClinicalTrials.gov Identifier: NCT02635373
Recruitment Status : Recruiting
First Posted : December 18, 2015
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

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.

Condition or disease
Calcific Uremic Arteriolopathy (CUA) Calciphylaxis

Detailed Description:

Calcific uremic arteriolopathy (CUA, calciphylaxis) is a rare disease (ORPHA280062) with dramatically high mortality characterized clinically by the occurrence of painful debilitating cutaneous lesions and ulcerations. Median survival time is about 1.5 years. Many uncertainties still exist about risk factors and optimal therapy. CUA mainly occurs in patients with severe renal insufficiency or ESRD.

The aim of the present initiative is to establish an international (European) observational registry for CUA patients. This registry will help to reach a critical mass of CUA patients, will allow novel insights into pathophysiology, and will help establishing systematically an overview upon risk factors and long-term outcome of CUA patients. The design of the international registry is supposed to adopt the structure of the presently running nation-wide German calciphylaxis registry.

The investigators plan to initiate a registry in which treating physicians can provide data upon demographics, clinical picture, comorbidities, medical treatments and laboratory data at the time of diagnosis and serial follow-up time points. In addition investigators will build-up a biobank for full blood, serum and plasma samples as well as tissue samples.

The registry will allow investigations regarding potential subgroups of patients (proximal versus distal forms of CUA), geno-phenotype correlations, description of international state-of-the-art treatment, and identification of preventive tools, risk factors and biomarkers for estimation of prognosis.

Furthermore, the registry will be the nidus for further scientific exchange between experts and clinicians on the field of uremic vascular calcification.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: European Calciphylaxis Registry Network
Study Start Date : December 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Prognosis of patients with calciphylaxis (survival time) [ Time Frame: 5 years ]
    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.


Secondary Outcome Measures :
  1. Diagnosis of calciphylaxis [ Time Frame: 5 years ]
    An internet based multilingual registry in which treating physicians can provide patients' data (online questionnaire) upon: demographics, the clinical picture including photo documentation and pain scale (VAS) reporting, comorbidities, medical treatments including dialysis and operations, wound management and laboratory data (serum-creatinine, , BUN, ionized / total calcium, serum phosphorus, PTH, alkaline, phosphatase, calcidiol, albumin, CRP, HbA1c, cholesterol, ferritin, hemoglobin, leukocyte count). The international registry will allow a more rapid identification of patients with calciphylaxis than on a national basis alone, will help establish diagnostic algorithms, and will increase the awareness of the disease.

  2. Risk factors [ Time Frame: 5 years ]
    More detailed identification of risk factors: the registry will allow investigations regarding potential subgroups of patients (proximal versus distal forms of CUA), geno-phenotype correlations, description of international state-of-the-art treatment, and identification of preventive tools, risk factors and biomarkers for estimation of prognosis.

  3. Factors influencing prognosis of patients with calciphylaxis [ Time Frame: 5 years ]
    Evaluation of the collected data from the time point of diagnosis and serial follow-up time points and further scientific exchange between experts and clinicians on the field of uremic vascular calcification will allow identification of subgroups of patients with potentially distinct pattern of risk factors, clinical picture and prognosis, and establishing factors influencing prognosis of patients with calciphylaxis and to develop novel and/or individualized treatment strategies

  4. Novel therapeutic options [ Time Frame: 5 years ]
    By increasing the reported cases towards a critical threshold in Europe enabling the performance of RCTs comparing available or upcoming therapeutic options in CUA pts.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diagnosed CUA
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

• The subject is not able to give informed consent


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635373


Contacts
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Contact: Vincent Brandenburg, MD, Prof. +49 (0)241/80 ext 36072 calciphylaxis@ukaachen.de

Locations
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Germany
Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen Recruiting
Aachen, NRW, Germany, 52074
Contact: Verena Deserno, M.Sc.    +49 241 80 ext 80092    vdeserno@ukaachen.de   
Principal Investigator: Vincent Brandenburg, MD         
Sponsors and Collaborators
RWTH Aachen University
Additional Information:

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

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02635373    
Other Study ID Numbers: 13-093
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016
Keywords provided by RWTH Aachen University:
Calciphylaxis
Rare disease (ORPHA280062)
Renal insufficiency
ESRD
Calcification
Chronic kidney disease
Dialysis
Vascular disease
Additional relevant MeSH terms:
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Calciphylaxis
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases