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Non-valvular Atrial Fibrillation (NVAF)XARENONCT02663076

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

An observational study of Non-valvular Atrial Fibrillation (NVAF) and Chronic Kidney Disease (CKD), run by GWT-TUD GmbH at 121 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
1,700 participants
Where
121 sitesin 5 countries
Study dates
Apr 2016to 4 Apr 2022
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with CKD (eGFR15-49 mL/min per 1.73 m2) and NVAF are in the focus of the XARENO registry

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

121 sites in 5 countries.

121 sites in 5 countries

Germany75 sites

  • Kardiologische Praxis

    Bad Homburg

  • Schilddrüsenzentrum Bergstrasse/Praxis Innere Medizin

    Bensheim, 64625

  • FA für Innere Medizin

    Bergisch Gladbach, 51429

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Vivantes Klinikum im Friedrichshain

    Berlin, 10405

  • Franziskus-Krankenhaus Berlin

    Berlin, 10787

  • Praxis Rankestrasse

    Berlin, 10789

  • MVZ Dres. Ramdohr

    Berlin, 12043

  • St. Joseph Krankenhaus Berlin-Tempelhof GmbH

    Berlin, 12101

  • Charité - Universitätsmedizin Berlin

    Berlin, 12200

  • Facharzt für Allgemeinmedizin

    Berlin, 12459

  • Praxis

    Berlin, 13189

  • Studienzentrum Schwittay

    Böhlen, 04564

  • Kardiologische Arztpraxis

    Borsdorf, 04451

  • Städtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38126

  • Krankenhaus Buchholz

    Buchholz, 21244

  • Gemeinschaftspraxis Kellner und Ehrhardt

    Camburg, 07774

  • Klinikum Coburg GmbH

    Coburg, 96450

  • Uniklinik Köln

    Cologne, 50937

  • Kardiologische Partnerschaftsgesellschaft

    Cottbus, 03046

  • ZID- Zentrum für Innere Medizin Dachau

    Dachau, 85221

  • Kardiovaskuläres Zentrum Darmstadt

    Darmstadt, 64287

  • Klinikum Dortmund GmbH

    Dortmund, 44137

  • Kardiologie Dortmund

    Dortmund, 44141

  • Nephrologische Praxis

    Dortmund, 44263

  • Praxisklinik Herzkreislauf am Wasaplatz

    Dresden, 01219

  • Praxis Dr. med Steffen Fischer

    Dresden, 01277

  • Praxis Dr. med. Christoph Axthelm & Kollegen

    Dresden, 01277

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Gemeinschaftspraxis Dr. med. Sybille Jänsch

    Dresden, 01309

  • Praxis Dr. med. Frank Richard

    Erfurt, 99084

  • Klinikum Esslingen GmbH

    Esslingen am Neckar, 73730

  • Gemeinschaftspraxis im Altstadtcarree, Kardiologie

    Fulda, 36037

  • MVZ Prof. Mathey, Prof. Schofer GmbH

    Hamburg, 22527

  • Herzpraxis Altona

    Hamburg, 22765

  • Zentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen

    Hanover, 30625

  • DOKUSAN

    Herne, 44623

  • Universitätsklinikum des Saarlandes

    Homburg, 66421

  • Praxisnetz Dr. Haaß & Kollegen

    Inden, 52459

  • Westpfalz-Klinikum GmbH

    Kaiserslautern, 67655

  • Studienzentrum Dr. med. Karl-Friedrich Appel

    Kassel, 34121

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105

  • Gemeinschaftspraxis Wittwer, Bargemann, Baar

    Kiel, 24116

  • Praxis

    Königsbrück, 01936

  • Gemeinschaftspraxis Scheuermann & Persicke

    Kornwestheim, 70806

  • Eickenhof Dialyse - Gemeinschaftspraxis

    Langenhagen, 30851

  • Klinikum St. Georg GmbH

    Leipzig, 04129

  • Klinikum Leverkusen

    Leverkusen, 51375

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Universitätsklinikum Marburg

    Marburg, 35033

  • Praxis Dr. med. Jens Taggeselle

    Markkleeberg, 04416

  • Internistisches Facharztzentrum

    Memmingen, 87700

  • Herz-Gefäß-Zentrum Nymphenburg

    München, 80638

  • Marienkrankenhaus Klinikum St. Elisabeth

    Neuwied, 56564

  • Kardiologische Gemeinschaftspraxis

    Nienburg, 31582

  • Kardiologie am Weißen Turm

    Nuremberg, 90402

  • Praxis für Innere Medizin

    Nuremberg, 90449

  • Klinikum Nürnberg Süd

    Nuremberg, 90471

  • via medis Nierenzentrum Oldenburg MVZ

    Oldenburg, 26127

  • Fachärztin für Allgemeinmedizin

    Osnabrück, 49074

  • MVZ Birkenallee

    Papenburg, 26871

  • Internistische Gemeinschaftspraxis

    Passau, 94032

  • Cardiologicum Prina

    Pirna, 01796

  • Praxis Dr. med. Christoph Axthelm & Kollegen

    Pirna, 01796

  • Paracelsus-Harz-Klinik

    Quedlinburg, 06485

  • KardioPrax Remscheid

    Remscheid, 42853

  • Zentrum für Prävention und Rehabilitation

    Siegen, 57072

  • Studienzentrum der Herzklinik Ulm GbR

    Ulm, 89077

  • Internistische Praxis Vellmar

    Vellmar, 34246

  • Schwarzwald-Baar-Klinikum

    Villingen-Schwenningen, 78052

  • Gemeinschaftspraxis Drs. Grosskopf

    Wallerfing, 94574

  • Kliniken Nordoberpfalz AG

    Weiden, 92637

  • Praxis Dr. med. Jörg Brosche

    Weinböhla, 01689

  • Kardiologische Praxis Dr. med. Ayham Al Zoebi

    Wermsdorf, 04779

  • Ev. Krankenhaus Witten gGmbH

    Witten, 58455

Other trials in Germany

France27 sites

  • Clinique Sainte-Isabelle

    Abbeville, 80100

  • CH Abbeville

    Abbeville, 80142

  • CHU Amiens

    Amiens, 80054

  • CHU Angers

    Angers, 49933

  • CHU Angers

    Angers

  • CH Argenteuil Centre Hospitalier Victor Dupouy

    Argenteuil, 95107

  • CHU Avicenne (AP-HP)

    Bobigny

  • CHU Bordeaux-Hôpital Saint André

    Bordeaux, 33075

  • CHU Bordeaux-Hôpital Pellegrin

    Bordeaux, 33076

  • CHRU Brest-Hôpital la Cavale Blanche

    Brest

  • CH Cholet

    Cholet, 49300

  • CHU Clermont Ferrand

    Clermont-Ferrand, 63000

  • Hôpital Louis Mourier (AP-HP)

    Colombes, 92700

  • CH de Compiègne-Noyon (CHNC)

    Compiègne, 60200

  • Hôpital Henri Mondor (AP-HP)

    Créteil, 94010

  • CHD Vendée

    La Roche-sur-Yon

  • CHG de Chartres-Hôpital Général Louis Pasteur

    Le Coudray, 28630

  • CHR Metz-Thionville, Hôpital de Mercy

    Metz

  • CHU Nantes-site Hotel Dieu

    Nantes, 44093

  • CHU Carémeau

    Nîmes, 30000

  • Pitié-Salpètrière Hospital (AP-HP)

    Paris, 75013

  • Claude Bernard - Bichat Hospital

    Paris, 75018

  • Hôpital Bretonneau (AP-HP)

    Paris, 75018

  • CHU Nantes-Hôpital nord Laennec

    Saint-Herblain, 44800

  • CHRU Strasbourg Nouvel Hôpital Civil

    Strasbourg, 67000

  • CHI Toulon La Seyne sur mer - Hopital Sainte Musse

    Toulon, 83056

  • Hôpital Nord Franche Comté

    Trévenans

Other trials in France

Austria8 sites

  • Krankenhaus St. Josef Braunau

    Braunau am Inn, 5280

  • Medizinische Universitätsklinik

    Graz, 8036

  • Allgemeines Krankenhaus der STadt Linz

    Linz, 4020

  • Krankenhaus der Elisabethinen Linz

    Linz, 4020

  • Medizinische Universität Wien

    Vienna, 1090

  • Meidzinische Universität Wien

    Vienna, 1090

  • Sozialmedizinischer Zentrum-Süd Kaiser-Franz-Josef-Spital

    Vienna, 1100

  • Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel

    Vienna, 1130

Other trials in Austria

Belgium8 sites

  • Centre Hospitalier EpiCURA-Baudour

    Baudour

  • CUB Hôpital ERASME

    Brussels

  • CHU de Charleroi

    Charleroi, 6000

  • Centre Hospitalier Régional de la Citadelle

    Liège, 4000

  • Centre Hospitalier Chrétien (CHC) St Joseph

    Liège

  • Centre Hospitalier Régional de la Citadelle

    Liège

  • Centre Hospitalier Universiatire du SART-TILMAN

    Liège

  • Centre Hospitalier de Wallonie Picarde (Chwapi)

    Tournai

Other trials in Belgium

Switzerland3 sites

  • Kantonsspital Aarau AG

    Aarau, 5001

  • Kantonsspital Baden AG

    Baden, 5404

  • Klinik Hirslanden

    Zurich, 8032

Other trials in Switzerland

About this study

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.

Read the 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.

Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02663076
Study groupRoleWhat they receive
VKA - Vitamin K antagonist groupVKAs used in correspondence with the national guidelines for therapy of NVAF in the respective country.
Rivaroxaban groupRivaroxaban used in correspondence with the national guidelines for therapy of NVAF in the respective country.
noAC groupnoAC used in correspondence with the national guidelines for therapy of NVAF in the respective country.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. decline in eGFR in mL/min per 1.73 m2

    Measured: 12 month

  2. major bleeding

    Measured: 12 month

  3. all-cause mortality

    Measured: 12 month

  4. TIA, stroke or systemic arterial embolism

    Measured: 12 month

  5. major cardiovascular events (MACE)

    Measured: 12 month

  6. symptomatic venous thromboembolic events

    Measured: 12 month

  7. net-clinical benefit (stroke and other thromboembolic events, major bleeding, and all-cause mortality)

    Measured: 12 month

Secondary outcomes (10)

  1. initiation of chronic renal replacement therapy

    Measured: 12 month

  2. eGFR < 15 mL/min per 1.73 m2 (CKD Stage 5 Dialysis and Non-Dialysis)

    Measured: 12 month

  3. eGFR decline of ≥ 30%

    Measured: 12 month

  4. doubling of serum creatine concentration

    Measured: 12 month

  5. 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

    Measured: 12 month, 18 month

  6. rates of hospitalizations

    Measured: 12 month, 18 month

  7. length of hospitalizations

    Measured: 12 month, 18 month

  8. causes of hospitalizations

    Measured: 12 month, 18 month

  9. persistence with OAC therapy

    Measured: 12 month, 18 month

  10. reasons for OAC therapy discontinuation

    descriptive analysis of reasons for therapy discontinuation (verbal description by investigator)

    Measured: 12 month, 18 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionJan 2022
  4. Study completion4 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,700 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02663076
Sponsor's protocol ID
XARENO-Registry
Acronym
XARENO
Status last verified
Jul 2022
First submitted
17 Dec 2015
Last updated
19 Jul 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Non-valvular Atrial Fibrillation (NVAF) and Chronic Kidney Disease (CKD), run by GWT-TUD GmbH at 121 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in Germany, France, Austria, Belgium, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

decline in eGFR in mL/min per 1.73 m2 (time frame: 12 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02663076.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.

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