Clinical trial NCT02663076: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-valvular Atrial Fibrillation (NVAF)
Chronic Kidney Disease (CKD)
Lead sponsor: GWT-TUD GmbH
Sponsor class: OTHER
Collaborators: name: ClinStat GmbH
First posted: 2016-01-26
Enrollment: 1700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

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

Primary outcomes:
measure: decline in eGFR in mL/min per 1.73 m2
timeFrame: 12 month
measure: major bleeding
timeFrame: 12 month
measure: all-cause mortality
timeFrame: 12 month
measure: TIA, stroke or systemic arterial embolism
timeFrame: 12 month
measure: major cardiovascular events (MACE)
timeFrame: 12 month
measure: symptomatic venous thromboembolic events
timeFrame: 12 month
measure: net-clinical benefit (stroke and other thromboembolic events, major bleeding, and all-cause mortality)
timeFrame: 12 month
Secondary outcomes:
measure: initiation of chronic renal replacement therapy
timeFrame: 12 month
measure: eGFR < 15 mL/min per 1.73 m2 (CKD Stage 5 Dialysis and Non-Dialysis)
timeFrame: 12 month
measure: eGFR decline of ≥ 30%
timeFrame: 12 month
measure: doubling of serum creatine concentration
timeFrame: 12 month
measure: 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
timeFrame: 12 month, 18 month
measure: rates of hospitalizations
timeFrame: 12 month, 18 month
measure: length of hospitalizations
timeFrame: 12 month, 18 month
measure: causes of hospitalizations
timeFrame: 12 month, 18 month
measure: persistence with OAC therapy
timeFrame: 12 month, 18 month
measure: reasons for OAC therapy discontinuation
timeFrame: 12 month, 18 month
Other outcomes:
Locations:
city: Braunau Am Inn
country: Austria
facility: Krankenhaus St. Josef Braunau
city: Graz
country: Austria
facility: Medizinische Universitätsklinik
city: Linz
country: Austria
facility: Allgemeines Krankenhaus der STadt Linz
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen Linz
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Wien
country: Austria
facility: Meidzinische Universität Wien
city: Wien
country: Austria
facility: Sozialmedizinischer Zentrum-Süd Kaiser-Franz-Josef-Spital
city: Wien
country: Austria
facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
city: Baudour
country: Belgium
facility: Centre Hospitalier EpiCURA-Baudour
city: Bruxelles
country: Belgium
facility: CUB Hôpital ERASME
city: Charleroi
country: Belgium
facility: CHU de Charleroi
city: Liège
country: Belgium
facility: Centre Hospitalier Régional de la Citadelle
city: Liège
country: Belgium
facility: Centre Hospitalier Chrétien (CHC) St Joseph
city: Liège
country: Belgium
facility: Centre Hospitalier Régional de la Citadelle
city: Liège
country: Belgium
facility: Centre Hospitalier Universiatire du SART-TILMAN
city: Tournai
country: Belgium
facility: Centre Hospitalier de Wallonie Picarde (Chwapi)
city: Abbeville
country: France
facility: Clinique Sainte-Isabelle
city: Abbeville
country: France
facility: CH Abbeville
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: CHU Angers
city: Angers
country: France
facility: CHU Angers
city: Argenteuil
country: France
facility: CH Argenteuil Centre Hospitalier Victor Dupouy
city: Bobigny
country: France
facility: CHU Avicenne (AP-HP)
city: Bordeaux
country: France
facility: CHU Bordeaux-Hôpital Saint André
city: Bordeaux
country: France
facility: CHU Bordeaux-Hôpital Pellegrin
city: Brest
country: France
facility: CHRU Brest-Hôpital la Cavale Blanche
city: Cholet
country: France
facility: CH Cholet
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand
city: Colombes
country: France
facility: Hôpital Louis Mourier (AP-HP)
city: Compiègne
country: France
facility: CH de Compiègne-Noyon (CHNC)
city: Créteil
country: France
facility: Hôpital Henri Mondor (AP-HP)
city: La Roche sur yon
country: France
facility: CHD Vendée
city: Le Coudray
country: France
facility: CHG de Chartres-Hôpital Général Louis Pasteur
city: Metz
country: France
facility: CHR Metz-Thionville, Hôpital de Mercy
city: Nantes
country: France
facility: CHU Nantes-site Hotel Dieu
city: Nimes
country: France
facility: CHU Carémeau
city: Paris
country: France
facility: Pitié-Salpètrière Hospital (AP-HP)
city: Paris
country: France
facility: Claude Bernard - Bichat Hospital
city: Paris
country: France
facility: Hôpital Bretonneau (AP-HP)
city: Saint-Herblain
country: France
facility: CHU Nantes-Hôpital nord Laennec
city: Strasbourg
country: France
facility: CHRU Strasbourg Nouvel Hôpital Civil
city: Toulon
country: France
facility: CHI Toulon La Seyne sur mer - Hopital Sainte Musse
city: Trevenans
country: France
facility: Hôpital Nord Franche Comté
city: Bad Homburg
country: Germany
facility: Kardiologische Praxis
city: Bensheim
country: Germany
facility: Schilddrüsenzentrum Bergstrasse/Praxis Innere Medizin
city: Bergisch Gladbach
country: Germany
facility: FA für Innere Medizin
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Vivantes Klinikum im Friedrichshain
city: Berlin
country: Germany
facility: Franziskus-Krankenhaus Berlin
city: Berlin
country: Germany
facility: Praxis Rankestrasse
city: Berlin
country: Germany
facility: MVZ Dres. Ramdohr
city: Berlin
country: Germany
facility: St. Joseph Krankenhaus Berlin-Tempelhof GmbH
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Facharzt für Allgemeinmedizin
city: Berlin
country: Germany
facility: Praxis
city: Borsdorf
country: Germany
facility: Kardiologische Arztpraxis
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig gGmbH
city: Buchholz
country: Germany
facility: Krankenhaus Buchholz
city: Böhlen
country: Germany
facility: Studienzentrum Schwittay
city: Camburg
country: Germany
facility: Gemeinschaftspraxis Kellner und Ehrhardt
city: Coburg
country: Germany
facility: Klinikum Coburg GmbH
city: Cottbus
country: Germany
facility: Kardiologische Partnerschaftsgesellschaft
city: Dachau
country: Germany
facility: ZID- Zentrum für Innere Medizin Dachau
city: Darmstadt
country: Germany
facility: Kardiovaskuläres Zentrum Darmstadt
city: Dortmund
country: Germany
facility: Klinikum Dortmund GmbH
city: Dortmund
country: Germany
facility: Kardiologie Dortmund
city: Dortmund
country: Germany
facility: Nephrologische Praxis
city: Dresden
country: Germany
facility: Praxisklinik Herzkreislauf am Wasaplatz
city: Dresden
country: Germany
facility: Praxis Dr. med Steffen Fischer
city: Dresden
country: Germany
facility: Praxis Dr. med. Christoph Axthelm & Kollegen
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Dr. med. Sybille Jänsch
city: Erfurt
country: Germany
facility: Praxis Dr. med. Frank Richard
city: Esslingen
country: Germany
facility: Klinikum Esslingen GmbH
city: Fulda
country: Germany
facility: Gemeinschaftspraxis im Altstadtcarree, Kardiologie
city: Hamburg
country: Germany
facility: MVZ Prof. Mathey, Prof. Schofer GmbH
city: Hamburg
country: Germany
facility: Herzpraxis Altona
city: Hannover
country: Germany
facility: Zentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen
city: Herne
country: Germany
facility: DOKUSAN
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Inden
country: Germany
facility: Praxisnetz Dr. Haaß & Kollegen
city: Kaiserslautern
country: Germany
facility: Westpfalz-Klinikum GmbH
city: Kassel
country: Germany
facility: Studienzentrum Dr. med. Karl-Friedrich Appel
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Kiel
country: Germany
facility: Gemeinschaftspraxis Wittwer, Bargemann, Baar
city: Kornwestheim
country: Germany
facility: Gemeinschaftspraxis Scheuermann & Persicke
city: Köln
country: Germany
facility: Uniklinik Köln
city: Königsbrück
country: Germany
facility: Praxis
city: Langenhagen
country: Germany
facility: Eickenhof Dialyse - Gemeinschaftspraxis
city: Leipzig
country: Germany
facility: Klinikum St. Georg GmbH
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Marburg
country: Germany
facility: Universitätsklinikum Marburg
city: Markkleeberg
country: Germany
facility: Praxis Dr. med. Jens Taggeselle
city: Memmingen
country: Germany
facility: Internistisches Facharztzentrum
city: München
country: Germany
facility: Herz-Gefäß-Zentrum Nymphenburg
city: Neuwied
country: Germany
facility: Marienkrankenhaus Klinikum St. Elisabeth
city: Nienburg
country: Germany
facility: Kardiologische Gemeinschaftspraxis
city: Nürnberg
country: Germany
facility: Kardiologie am Weißen Turm
city: Nürnberg
country: Germany
facility: Praxis für Innere Medizin
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Süd
city: Oldenburg
country: Germany
facility: via medis Nierenzentrum Oldenburg MVZ
city: Osnabrück
country: Germany
facility: Fachärztin für Allgemeinmedizin
city: Papenburg
country: Germany
facility: MVZ Birkenallee
city: Passau
country: Germany
facility: Internistische Gemeinschaftspraxis
city: Pirna
country: Germany
facility: Cardiologicum Prina
city: Pirna
country: Germany
facility: Praxis Dr. med. Christoph Axthelm & Kollegen
city: Quedlinburg
country: Germany
facility: Paracelsus-Harz-Klinik
city: Remscheid
country: Germany
facility: KardioPrax Remscheid
city: Siegen
country: Germany
facility: Zentrum für Prävention und Rehabilitation
city: Ulm
country: Germany
facility: Studienzentrum der Herzklinik Ulm GbR
city: Vellmar
country: Germany
facility: Internistische Praxis Vellmar
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar-Klinikum
city: Wallerfing
country: Germany
facility: Gemeinschaftspraxis Drs. Grosskopf
city: Weiden
country: Germany
facility: Kliniken Nordoberpfalz AG
city: Weinböhla
country: Germany
facility: Praxis Dr. med. Jörg Brosche
city: Wermsdorf
country: Germany
facility: Kardiologische Praxis Dr. med. Ayham Al Zoebi
city: Witten
country: Germany
facility: Ev. Krankenhaus Witten gGmbH
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau AG
city: Baden
country: Switzerland
facility: Kantonsspital Baden AG
city: Zürich
country: Switzerland
facility: Klinik Hirslanden
Study officials:
affiliation: Charite University, Berlin, Germany
name: Reinhold Kreutz, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: University Clinic Technical University Dresden
name: Jan Beyer-Westendorf, PD Dr.
role: STUDY_CHAIR
References: