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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
Sponsor:
Collaborator:
ClinStat GmbH
Information provided by (Responsible Party):
GWT-TUD GmbH

Tracking Information
First Submitted Date December 17, 2015
First Posted Date January 26, 2016
Last Update Posted Date August 2, 2019
Study Start Date April 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 21, 2016)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 4, 2016)
  • 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)
Original Secondary Outcome Measures
 (submitted: January 21, 2016)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Factor XA - Inhibition in RENal Patients With Non-valvular Atrial Fibrillation - Observational Registry
Official Title Factor XA - Inhibition in RENal Patients With Non-valvular Atrial Fibrillation - Observational Registry
Brief Summary

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.

Detailed 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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 18 Months
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with CKD (eGFR15-49 mL/min per 1.73 m2) and NVAF are in the focus of the XARENO registry
Condition
  • Non-valvular Atrial Fibrillation (NVAF)
  • Chronic Kidney Disease (CKD)
Intervention Not Provided
Study Groups/Cohorts
  • VKA - Vitamin K antagonist group
    VKAs used in correspondence with the national guidelines for therapy of NVAF in the respective country.
  • Rivaroxaban group
    Rivaroxaban used in correspondence with the national guidelines for therapy of NVAF in the respective country.
  • noAC group
    noAC used in correspondence with the national guidelines for therapy of NVAF in the respective country.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 21, 2016)
2500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • male and female patients, age ≥ 18 years
  • CKD with eGFR 15 - 49 mL/min per 1.73 m2
  • non-valvular atrial fibrillation (NVAF) with indication for anticoagulation therapy
  • a treatment strategy for the ≥ 3 previous months before enrolment with either: rivaroxaban or VKA (OAC cohorts) or no anticoagulation (no AC cohort)
  • informed consent
  • availability for follow up
  • life expectancy of ≥6 months

Exclusion Criteria:

  • exclusion criteria according to the local product information for the respective anticoagulation treatment
  • planned treatment with other anticoagulants
  • expected renal-replacement therapy within the next 3 months
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Katja Jersemann, Dr. +49 351 25933 ext 188 katja.jersemann@gmx.net
Listed Location Countries Austria,   Belgium,   France,   Germany,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02663076
Other Study ID Numbers XARENO-Registry
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party GWT-TUD GmbH
Study Sponsor GWT-TUD GmbH
Collaborators ClinStat GmbH
Investigators
Study Director: Reinhold Kreutz, Prof. Dr. Charite University, Berlin, Germany
Study Chair: Jan Beyer-Westendorf, PD Dr. University Clinic Technical University Dresden
PRS Account GWT-TUD GmbH
Verification Date February 2019