Factor XA - Inhibition in RENal Patients With Non-valvular Atrial Fibrillation - Observational Registry (XARENO)
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|ClinicalTrials.gov Identifier: NCT02663076|
Recruitment Status : Recruiting
First Posted : January 26, 2016
Last Update Posted : August 2, 2019
The multicenter registry will collect clinical data from 2500 patients with non valvular atrial fibrillation (NVAF) and chronic kidney disease (eGFR 15-49 mL/min per 1.73 m2).
The overall objective of this registry is to assess chronic kidney disease (CKD) progression and clinical outcomes with regard to anticoagulation strategies in NVAF patients with eGFR 15-49 mL/min per 1.73 m2 in routine clinical practice.
|Condition or disease|
|Non-valvular Atrial Fibrillation (NVAF) Chronic Kidney Disease (CKD)|
This is a prospective registry allowing a structured, non-interventional collection of data. Participating physicians will not be subject to any instructions with regard to the diagnosis and therapy of their patients. All patient treatment is carried out within clinical routine, at the discretion of the physician and according to existing treatment guidelines.
This registry will be carried out as an investigator-initiated, multicentre, prospective, non-interventional and observational registry at approximately 200 sites in Germany, Austria, Switzerland, France, Belgium and Luxembourg.
The registry will collect clinical data of approximately 2500 patients with CKD (eGFR 15-49 mL/min per 1.73 m2) and NVAF receiving rivaroxaban, OAC with VKA, or no AC therapy, who are prospectively followed for a flexible duration with at least for 12 months (for the last enrolled patient) and with an estimated mean of 18 months for the whole study cohort.
It is planned to include 1000 patients with rivaroxaban therapy and VKA therapy, respectively. Enrolment can be prolonged beyond 2500 patients until 1000 rivaroxaban patients are enrolled.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2500 participants|
|Target Follow-Up Duration:||18 Months|
|Official Title:||Factor XA - Inhibition in RENal Patients With Non-valvular Atrial Fibrillation - Observational Registry|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
VKA - Vitamin K antagonist group
VKAs used in correspondence with the national guidelines for therapy of NVAF in the respective country.
Rivaroxaban used in correspondence with the national guidelines for therapy of NVAF in the respective country.
noAC used in correspondence with the national guidelines for therapy of NVAF in the respective country.
- decline in eGFR in mL/min per 1.73 m2 [ Time Frame: 12 month ]
- major bleeding [ Time Frame: 12 month ]
- all-cause mortality [ Time Frame: 12 month ]
- TIA, stroke or systemic arterial embolism [ Time Frame: 12 month ]
- major cardiovascular events (MACE) [ Time Frame: 12 month ]
- symptomatic venous thromboembolic events [ Time Frame: 12 month ]
- net-clinical benefit (stroke and other thromboembolic events, major bleeding, and all-cause mortality) [ Time Frame: 12 month ]
- Timepoint of onset of chronic renal replacement therapy [ Time Frame: 12 month ]
- rates of hospitalizations [ Time Frame: 12 month, 18 month ]
- length of hospitalizations [ Time Frame: 12 month, 18 month ]
- causes of hospitalizations [ Time Frame: 12 month, 18 month ]
- duration with OAC therapy [ Time Frame: 12 month, 18 month ]
- major cardiovascular events (MACE) [ Time Frame: 12 month, 18 month ]
- reasons for OAC therapy discontinuation [ Time Frame: 12 month, 18 month ]descriptive analysis of reasons for therapy discontinuation (verbal description by investigator)
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): NCT02663076
|Contact: Katja Jersemann, Dr.||+49 351 25933 ext firstname.lastname@example.org|
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|Study Director:||Reinhold Kreutz, Prof. Dr.||Charite University, Berlin, Germany|
|Study Chair:||Jan Beyer-Westendorf, PD Dr.||University Clinic Technical University Dresden|