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

The multicenter registry will collect clinical data from 1600 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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease (CKD); Non-valvular Atrial Fibrillation (NVAF)

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 160 sites in Germany, Austria, Switzerland, France, Belgium and Luxembourg.

The registry will collect clinical data of approximately 1600 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 a minimal follow-up duration of 12 months until study end is announced (planned minimum 360 days / planned maximum 84 months).

The plan of the registry is to include at least 1600 patients with CKD and NVAF and rivaroxaban therapy or VKA therapy or no AC therapy.

The aim is to include at least 700 patients with rivaroxaban therapy and VKA therapy, respectively. Into the exploratory treatment arm of patients receiving no AC therapy about 100 patients will be included.

• Study Type: Observational
• Enrollment (Actual): 1700

Contacts and Locations

Study Locations

• Austria
  • Braunau Am Inn, Austria, 5280
    • Krankenhaus St. Josef Braunau
  • Graz, Austria, 8036
    • Medizinische Universitätsklinik
  • Linz, Austria, 4020
    • Krankenhaus der Elisabethinen Linz
  • Linz, Austria, 4020
    • Allgemeines Krankenhaus der Stadt Linz
  • Wien, Austria, 1090
    • Medizinische Universitat Wien
  • Wien, Austria, 1130
    • Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
  • Wien, Austria, 1090
    • Meidzinische Universität Wien
  • Wien, Austria, 1100
    • Sozialmedizinischer Zentrum-Süd Kaiser-Franz-Josef-Spital
• Belgium
  • Baudour, Belgium
    • Centre Hospitalier EpiCURA-Baudour
  • Bruxelles, Belgium
    • CUB Hôpital Erasme
  • Charleroi, Belgium, 6000
    • CHU de Charleroi
  • Liège, Belgium, 4000
    • Centre Hospitalier Regional de la Citadelle
  • Liège, Belgium
    • Centre Hospitalier Regional de la Citadelle
  • Liège, Belgium
    • Centre Hospitalier Chrétien (CHC) St Joseph
  • Liège, Belgium
    • Centre Hospitalier Universiatire du SART-TILMAN
  • Tournai, Belgium
    • Centre Hôspitalier de Wallonie Picarde (CHWAPI)
• France
  • Abbeville, France, 80142
    • CH Abbeville
  • Abbeville, France, 80100
    • Clinique Sainte-Isabelle
  • Amiens, France, 80054
    • CHU Amiens
  • Angers, France
    • CHU Angers
  • Angers, France, 49933
    • CHU Angers
  • Argenteuil, France, 95107
    • CH Argenteuil Centre Hospitalier Victor Dupouy
  • Bobigny, France
    • CHU Avicenne (AP-HP)
  • Bordeaux, France, 33075
    • CHU Bordeaux-Hôpital Saint André
  • Bordeaux, France, 33076
    • CHU Bordeaux-Hopital Pellegrin
  • Brest, France
    • CHRU Brest-Hôpital la Cavale Blanche
  • Cholet, France, 49300
    • Ch Cholet
  • Clermont Ferrand, France, 63000
    • CHU Clermont Ferrand
  • Colombes, France, 92700
    • Hôpital Louis Mourier (AP-HP)
  • Compiègne, France, 60200
    • CH de Compiègne-Noyon (CHNC)
  • Créteil, France, 94010
    • Hôpital Henri Mondor (AP-HP)
  • La Roche sur yon, France
    • CHD Vendée
  • Le Coudray, France, 28630
    • CHG de Chartres-Hôpital Général Louis Pasteur
  • Metz, France
    • CHR Metz-Thionville, Hôpital de Mercy
  • Nantes, France, 44093
    • CHU Nantes-site Hotel Dieu
  • Nimes, France, 30000
    • CHU Caremeau
  • Paris, France, 75013
    • Pitié-Salpêtrière Hospital (AP-HP)
  • Paris, France, 75018
    • Claude Bernard - Bichat Hospital
  • Paris, France, 75018
    • Hôpital Bretonneau (AP-HP)
  • Saint-Herblain, France, 44800
    • Chu Nantes-Hopital Nord Laennec
  • Strasbourg, France, 67000
    • CHRU Strasbourg Nouvel Hôpital Civil
  • Toulon, France, 83056
    • CHI Toulon La Seyne sur mer - Hopital Sainte Musse
  • Trevenans, France
    • Hopital Nord Franche Comte
• Germany
  • Bad Homburg, Germany
    • Kardiologische Praxis
  • Bensheim, Germany, 64625
    • Schilddrüsenzentrum Bergstrasse/Praxis Innere Medizin
  • Bergisch Gladbach, Germany, 51429
    • FA für Innere Medizin
  • Berlin, Germany, 12200
    • Charité - Universitätsmedizin Berlin
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin
  • Berlin, Germany, 10789
    • Praxis Rankestrasse
  • Berlin, Germany, 10405
    • Vivantes Klinikum im Friedrichshain
  • Berlin, Germany, 10787
    • Franziskus-Krankenhaus Berlin
  • Berlin, Germany, 12043
    • MVZ Dres. Ramdohr
  • Berlin, Germany, 12101
    • St. Joseph Krankenhaus Berlin-Tempelhof GmbH
  • Berlin, Germany, 12459
    • Facharzt für Allgemeinmedizin
  • Berlin, Germany, 13189
    • Praxis
  • Borsdorf, Germany, 04451
    • Kardiologische Arztpraxis
  • Braunschweig, Germany, 38126
    • Städtisches Klinikum Braunschweig gGmbH
  • Buchholz, Germany, 21244
    • Krankenhaus Buchholz
  • Böhlen, Germany, 04564
    • Studienzentrum Schwittay
  • Camburg, Germany, 07774
    • Gemeinschaftspraxis Kellner und Ehrhardt
  • Coburg, Germany, 96450
    • Klinikum Coburg GmbH
  • Cottbus, Germany, 03046
    • Kardiologische Partnerschaftsgesellschaft
  • Dachau, Germany, 85221
    • ZID- Zentrum für Innere Medizin Dachau
  • Darmstadt, Germany, 64287
    • Kardiovaskuläres Zentrum Darmstadt
  • Dortmund, Germany, 44137
    • Klinikum Dortmund GmbH
  • Dortmund, Germany, 44141
    • Kardiologie Dortmund
  • Dortmund, Germany, 44263
    • Nephrologische Praxis
  • Dresden, Germany, 01307
    • Universitätsklinikum Carl Gustav Carus Dresden
  • Dresden, Germany, 01219
    • Praxisklinik Herzkreislauf am Wasaplatz
  • Dresden, Germany, 01277
    • Praxis Dr. med Steffen Fischer
  • Dresden, Germany, 01277
    • Praxis Dr. med. Christoph Axthelm & Kollegen
  • Dresden, Germany, 01309
    • Gemeinschaftspraxis Dr. med. Sybille Jänsch
  • Erfurt, Germany, 99084
    • Praxis Dr. med. Frank Richard
  • Esslingen, Germany, 73730
    • Klinikum Esslingen GmbH
  • Fulda, Germany, 36037
    • Gemeinschaftspraxis im Altstadtcarree, Kardiologie
  • Hamburg, Germany, 22527
    • MVZ Prof. Mathey, Prof. Schofer GmbH
  • Hamburg, Germany, 22765
    • Herzpraxis Altona
  • Hannover, Germany, 30625
    • Zentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen
  • Herne, Germany, 44623
    • DOKUSAN
  • Homburg, Germany, 66421
    • Universitatsklinikum des Saarlandes
  • Inden, Germany, 52459
    • Praxisnetz Dr. Haaß & Kollegen
  • Kaiserslautern, Germany, 67655
    • Westpfalz-Klinikum GmbH
  • Kassel, Germany, 34121
    • Studienzentrum Dr. med. Karl-Friedrich Appel
  • Kiel, Germany, 24105
    • Universitätsklinikum Schleswig-Holstein
  • Kiel, Germany, 24116
    • Gemeinschaftspraxis Wittwer, Bargemann, Baar
  • Kornwestheim, Germany, 70806
    • Gemeinschaftspraxis Scheuermann & Persicke
  • Köln, Germany, 50937
    • Uniklinik Köln
  • Königsbrück, Germany, 01936
    • Praxis
  • Langenhagen, Germany, 30851
    • Eickenhof Dialyse - Gemeinschaftspraxis
  • Leipzig, Germany, 04129
    • Klinikum St. Georg GmbH
  • Leverkusen, Germany, 51375
    • Klinikum Leverkusen
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Marburg, Germany, 35033
    • Universitätsklinikum Marburg
  • Markkleeberg, Germany, 04416
    • Praxis Dr. med. Jens Taggeselle
  • Memmingen, Germany, 87700
    • Internistisches Facharztzentrum
  • München, Germany, 80638
    • Herz-Gefäß-Zentrum Nymphenburg
  • Neuwied, Germany, 56564
    • Marienkrankenhaus Klinikum St. Elisabeth
  • Nienburg, Germany, 31582
    • Kardiologische Gemeinschaftspraxis
  • Nürnberg, Germany, 90471
    • Klinikum Nürnberg Süd
  • Nürnberg, Germany, 90402
    • Kardiologie am Weißen Turm
  • Nürnberg, Germany, 90449
    • Praxis für Innere Medizin
  • Oldenburg, Germany, 26127
    • via medis Nierenzentrum Oldenburg MVZ
  • Osnabrück, Germany, 49074
    • Fachärztin für Allgemeinmedizin
  • Papenburg, Germany, 26871
    • MVZ Birkenallee
  • Passau, Germany, 94032
    • Internistische Gemeinschaftspraxis
  • Pirna, Germany, 01796
    • Cardiologicum Prina
  • Pirna, Germany, 01796
    • Praxis Dr. med. Christoph Axthelm & Kollegen
  • Quedlinburg, Germany, 06485
    • Paracelsus-Harz-Klinik
  • Remscheid, Germany, 42853
    • KardioPrax Remscheid
  • Siegen, Germany, 57072
    • Zentrum für Prävention und Rehabilitation
  • Ulm, Germany, 89077
    • Studienzentrum der Herzklinik Ulm GbR
  • Vellmar, Germany, 34246
    • Internistische Praxis Vellmar
  • Villingen-Schwenningen, Germany, 78052
    • Schwarzwald-Baar-Klinikum
  • Wallerfing, Germany, 94574
    • Gemeinschaftspraxis Drs. Grosskopf
  • Weiden, Germany, 92637
    • Kliniken Nordoberpfalz AG
  • Weinböhla, Germany, 01689
    • Praxis Dr. med. Jörg Brosche
  • Wermsdorf, Germany, 04779
    • Kardiologische Praxis Dr. med. Ayham Al Zoebi
  • Witten, Germany, 58455
    • Ev. Krankenhaus Witten gGmbH
• Switzerland
  • Aarau, Switzerland, 5001
    • Kantonsspital Aarau AG
  • Baden, Switzerland, 5404
    • Kantonsspital Baden AG
  • Zürich, Switzerland, 8032
    • Klinik Hirslanden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
decline in eGFR in mL/min per 1.73 m2	12 month
major bleeding	12 month
all-cause mortality	12 month
TIA, stroke or systemic arterial embolism	12 month
major cardiovascular events (MACE)	12 month
symptomatic venous thromboembolic events	12 month
net-clinical benefit (stroke and other thromboembolic events, major bleeding, and all-cause mortality)	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
initiation of chronic renal replacement therapy		12 month
eGFR < 15 mL/min per 1.73 m2 (CKD Stage 5 Dialysis and Non-Dialysis)		12 month
eGFR decline of ≥ 30%		12 month
doubling of serum creatine concentration		12 month
acute kidney injury (AKI) events defined as acute kidney injury associated with either hospitalization or emergency department visit, where AKI event is the lead diagnosis		12 month, 18 month
rates of hospitalizations		12 month, 18 month
length of hospitalizations		12 month, 18 month
causes of hospitalizations		12 month, 18 month
persistence with OAC therapy		12 month, 18 month
reasons for OAC therapy discontinuation	descriptive analysis of reasons for therapy discontinuation (verbal description by investigator)	12 month, 18 month

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): April 4, 2022

Study Registration Dates

• First Submitted: December 17, 2015
• First Submitted That Met QC Criteria: January 21, 2016
• First Posted (Estimate): January 26, 2016

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Urologic Diseases; Renal Insufficiency; Arrhythmias, Cardiac; Kidney Diseases; Renal Insufficiency, Chronic; Atrial Fibrillation
• Other Study ID Numbers: XARENO-Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No