Factor XA - Inhibition in RENal Patients With Non-valvular Atrial Fibrillation - Observational Registry
XARENO
1 other identifier
observational
1,700
5 countries
121
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Longer than P75 for all trials
121 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2015
CompletedFirst Posted
Study publicly available on registry
January 26, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2022
CompletedJuly 19, 2022
July 1, 2022
5.8 years
December 17, 2015
July 18, 2022
Conditions
Outcome Measures
Primary Outcomes (7)
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 Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (3)
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.
Eligibility Criteria
Patients with CKD (eGFR15-49 mL/min per 1.73 m2) and NVAF are in the focus of the XARENO registry
You may qualify if:
- 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
You may not qualify if:
- planned treatment with other anticoagulants
- expected renal-replacement therapy within the next 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GWT-TUD GmbHlead
- ClinStat GmbHcollaborator
Study Sites (121)
Krankenhaus St. Josef Braunau
Braunau am Inn, 5280, Austria
Medizinische Universitätsklinik
Graz, 8036, Austria
Allgemeines Krankenhaus der STadt Linz
Linz, 4020, Austria
Krankenhaus der Elisabethinen Linz
Linz, 4020, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
Meidzinische Universität Wien
Vienna, 1090, Austria
Sozialmedizinischer Zentrum-Süd Kaiser-Franz-Josef-Spital
Vienna, 1100, Austria
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
Vienna, 1130, Austria
Centre Hospitalier EpiCURA-Baudour
Baudour, Belgium
CUB Hôpital ERASME
Brussels, Belgium
CHU de Charleroi
Charleroi, 6000, Belgium
Centre Hospitalier Régional de la Citadelle
Liège, 4000, Belgium
Centre Hospitalier Chrétien (CHC) St Joseph
Liège, Belgium
Centre Hospitalier Régional de la Citadelle
Liège, Belgium
Centre Hospitalier Universiatire du SART-TILMAN
Liège, Belgium
Centre Hospitalier de Wallonie Picarde (Chwapi)
Tournai, Belgium
Clinique Sainte-Isabelle
Abbeville, 80100, France
CH Abbeville
Abbeville, 80142, France
CHU Amiens
Amiens, 80054, France
CHU Angers
Angers, 49933, France
CHU Angers
Angers, France
CH Argenteuil Centre Hospitalier Victor Dupouy
Argenteuil, 95107, France
CHU Avicenne (AP-HP)
Bobigny, France
CHU Bordeaux-Hôpital Saint André
Bordeaux, 33075, France
CHU Bordeaux-Hôpital Pellegrin
Bordeaux, 33076, France
CHRU Brest-Hôpital la Cavale Blanche
Brest, France
CH Cholet
Cholet, 49300, France
CHU Clermont Ferrand
Clermont-Ferrand, 63000, France
Hôpital Louis Mourier (AP-HP)
Colombes, 92700, France
CH de Compiègne-Noyon (CHNC)
Compiègne, 60200, France
Hôpital Henri Mondor (AP-HP)
Créteil, 94010, France
CHD Vendée
La Roche-sur-Yon, France
CHG de Chartres-Hôpital Général Louis Pasteur
Le Coudray, 28630, France
CHR Metz-Thionville, Hôpital de Mercy
Metz, France
CHU Nantes-site Hotel Dieu
Nantes, 44093, France
CHU Carémeau
Nîmes, 30000, France
Pitié-Salpètrière Hospital (AP-HP)
Paris, 75013, France
Claude Bernard - Bichat Hospital
Paris, 75018, France
Hôpital Bretonneau (AP-HP)
Paris, 75018, France
CHU Nantes-Hôpital nord Laennec
Saint-Herblain, 44800, France
CHRU Strasbourg Nouvel Hôpital Civil
Strasbourg, 67000, France
CHI Toulon La Seyne sur mer - Hopital Sainte Musse
Toulon, 83056, France
Hôpital Nord Franche Comté
Trévenans, France
Kardiologische Praxis
Bad Homburg, Germany
Schilddrüsenzentrum Bergstrasse/Praxis Innere Medizin
Bensheim, 64625, Germany
FA für Innere Medizin
Bergisch Gladbach, 51429, Germany
Charité - Universitätsmedizin Berlin
Berlin, 10117, Germany
Vivantes Klinikum im Friedrichshain
Berlin, 10405, Germany
Franziskus-Krankenhaus Berlin
Berlin, 10787, Germany
Praxis Rankestrasse
Berlin, 10789, Germany
MVZ Dres. Ramdohr
Berlin, 12043, Germany
St. Joseph Krankenhaus Berlin-Tempelhof GmbH
Berlin, 12101, Germany
Charité - Universitätsmedizin Berlin
Berlin, 12200, Germany
Facharzt für Allgemeinmedizin
Berlin, 12459, Germany
Praxis
Berlin, 13189, Germany
Kardiologische Arztpraxis
Borsdorf, 04451, Germany
Studienzentrum Schwittay
Böhlen, 04564, Germany
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, 38126, Germany
Krankenhaus Buchholz
Buchholz, 21244, Germany
Gemeinschaftspraxis Kellner und Ehrhardt
Camburg, 07774, Germany
Klinikum Coburg GmbH
Coburg, 96450, Germany
Uniklinik Köln
Cologne, 50937, Germany
Kardiologische Partnerschaftsgesellschaft
Cottbus, 03046, Germany
ZID- Zentrum für Innere Medizin Dachau
Dachau, 85221, Germany
Kardiovaskuläres Zentrum Darmstadt
Darmstadt, 64287, Germany
Klinikum Dortmund GmbH
Dortmund, 44137, Germany
Kardiologie Dortmund
Dortmund, 44141, Germany
Nephrologische Praxis
Dortmund, 44263, Germany
Praxisklinik Herzkreislauf am Wasaplatz
Dresden, 01219, Germany
Praxis Dr. med Steffen Fischer
Dresden, 01277, Germany
Praxis Dr. med. Christoph Axthelm & Kollegen
Dresden, 01277, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307, Germany
Gemeinschaftspraxis Dr. med. Sybille Jänsch
Dresden, 01309, Germany
Praxis Dr. med. Frank Richard
Erfurt, 99084, Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730, Germany
Gemeinschaftspraxis im Altstadtcarree, Kardiologie
Fulda, 36037, Germany
MVZ Prof. Mathey, Prof. Schofer GmbH
Hamburg, 22527, Germany
Herzpraxis Altona
Hamburg, 22765, Germany
Zentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen
Hanover, 30625, Germany
DOKUSAN
Herne, 44623, Germany
Universitätsklinikum des Saarlandes
Homburg, 66421, Germany
Praxisnetz Dr. Haaß & Kollegen
Inden, 52459, Germany
Westpfalz-Klinikum GmbH
Kaiserslautern, 67655, Germany
Studienzentrum Dr. med. Karl-Friedrich Appel
Kassel, 34121, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Gemeinschaftspraxis Wittwer, Bargemann, Baar
Kiel, 24116, Germany
Gemeinschaftspraxis Scheuermann & Persicke
Kornwestheim, 70806, Germany
Praxis
Königsbrück, 01936, Germany
Eickenhof Dialyse - Gemeinschaftspraxis
Langenhagen, 30851, Germany
Klinikum St. Georg GmbH
Leipzig, 04129, Germany
Klinikum Leverkusen
Leverkusen, 51375, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
Universitätsklinikum Marburg
Marburg, 35033, Germany
Praxis Dr. med. Jens Taggeselle
Markkleeberg, 04416, Germany
Internistisches Facharztzentrum
Memmingen, 87700, Germany
Herz-Gefäß-Zentrum Nymphenburg
München, 80638, Germany
Marienkrankenhaus Klinikum St. Elisabeth
Neuwied, 56564, Germany
Kardiologische Gemeinschaftspraxis
Nienburg, 31582, Germany
Kardiologie am Weißen Turm
Nuremberg, 90402, Germany
Praxis für Innere Medizin
Nuremberg, 90449, Germany
Klinikum Nürnberg Süd
Nuremberg, 90471, Germany
via medis Nierenzentrum Oldenburg MVZ
Oldenburg, 26127, Germany
Fachärztin für Allgemeinmedizin
Osnabrück, 49074, Germany
MVZ Birkenallee
Papenburg, 26871, Germany
Internistische Gemeinschaftspraxis
Passau, 94032, Germany
Cardiologicum Prina
Pirna, 01796, Germany
Praxis Dr. med. Christoph Axthelm & Kollegen
Pirna, 01796, Germany
Paracelsus-Harz-Klinik
Quedlinburg, 06485, Germany
KardioPrax Remscheid
Remscheid, 42853, Germany
Zentrum für Prävention und Rehabilitation
Siegen, 57072, Germany
Studienzentrum der Herzklinik Ulm GbR
Ulm, 89077, Germany
Internistische Praxis Vellmar
Vellmar, 34246, Germany
Schwarzwald-Baar-Klinikum
Villingen-Schwenningen, 78052, Germany
Gemeinschaftspraxis Drs. Grosskopf
Wallerfing, 94574, Germany
Kliniken Nordoberpfalz AG
Weiden, 92637, Germany
Praxis Dr. med. Jörg Brosche
Weinböhla, 01689, Germany
Kardiologische Praxis Dr. med. Ayham Al Zoebi
Wermsdorf, 04779, Germany
Ev. Krankenhaus Witten gGmbH
Witten, 58455, Germany
Kantonsspital Aarau AG
Aarau, 5001, Switzerland
Kantonsspital Baden AG
Baden, 5404, Switzerland
Klinik Hirslanden
Zurich, 8032, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Reinhold Kreutz, Prof. Dr.
Charite University, Berlin, Germany
- STUDY CHAIR
Jan Beyer-Westendorf, PD Dr.
University Clinic Technical University Dresden
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2015
First Posted
January 26, 2016
Study Start
April 1, 2016
Primary Completion
January 1, 2022
Study Completion
April 4, 2022
Last Updated
July 19, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share