Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.


Condition or disease
Non-valvular Atrial Fibrillation (NVAF) Chronic Kidney Disease (CKD)

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.


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. decline in eGFR in mL/min per 1.73 m2 [ Time Frame: 12 month ]
  2. major bleeding [ Time Frame: 12 month ]
  3. all-cause mortality [ Time Frame: 12 month ]
  4. TIA, stroke or systemic arterial embolism [ Time Frame: 12 month ]
  5. major cardiovascular events (MACE) [ Time Frame: 12 month ]
  6. symptomatic venous thromboembolic events [ Time Frame: 12 month ]
  7. net-clinical benefit (stroke and other thromboembolic events, major bleeding, and all-cause mortality) [ Time Frame: 12 month ]

Secondary Outcome Measures :
  1. Timepoint of onset of chronic renal replacement therapy [ Time Frame: 12 month ]
  2. rates of hospitalizations [ Time Frame: 12 month, 18 month ]
  3. length of hospitalizations [ Time Frame: 12 month, 18 month ]
  4. causes of hospitalizations [ Time Frame: 12 month, 18 month ]
  5. duration with OAC therapy [ Time Frame: 12 month, 18 month ]
  6. major cardiovascular events (MACE) [ Time Frame: 12 month, 18 month ]
  7. reasons for OAC therapy discontinuation [ Time Frame: 12 month, 18 month ]
    descriptive analysis of reasons for therapy discontinuation (verbal description by investigator)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

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): NCT02663076


Contacts
Layout table for location contacts
Contact: Katja Jersemann, Dr. +49 351 25933 ext 188 katja.jersemann@gmx.net

  Show 125 Study Locations
Sponsors and Collaborators
GWT-TUD GmbH
ClinStat GmbH
Investigators
Layout table for investigator information
Study Director: Reinhold Kreutz, Prof. Dr. Charite University, Berlin, Germany
Study Chair: Jan Beyer-Westendorf, PD Dr. University Clinic Technical University Dresden

Additional Information:

Layout table for additonal information
Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT02663076     History of Changes
Other Study ID Numbers: XARENO-Registry
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Urologic Diseases
Renal Insufficiency
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants