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
|Condition or disease|
|Calcific Uremic Arteriolopathy (CUA) Calciphylaxis|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|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|
- 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.
- 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.
- 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.
- 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
- 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.
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
|Contact: Vincent Brandenburg, MD, Prof.||+49 (0)241/80 ext firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Vincent Brandenburg, MD|