Factor XA - Inhibition in RENal Patients With Non-valvular Atrial Fibrillation - Observational Registry (XARENO-Registry)

Study identification

• EU PAS number:
  EUPAS32349
• Study ID:
  37091
• Official title and acronym:
  Factor XA - Inhibition in RENal Patients With Non-valvular Atrial Fibrillation - Observational Registry (XARENO-Registry)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  France

  Germany

  Switzerland
• Study description:
  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 status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 160 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:15/12/2015

Actual:15/12/2015

Study start date

Planned:01/02/2016

Actual:25/04/2016

Date of final study report

Actual:06/01/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

NCT02663076 - Clinicaltrials