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

Chronic Kidney Disease (CKD) Clinical Trial

— XARENO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02663076
• Other study ID #: XARENO-Registry
• Status: Completed
• Start date: April 2016
• Est. completion date: April 4, 2022

Study information

• Verified date: July 2022
• Source: GWT-TUD GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 anticoagulation strategies in NVAF patients with eGFR 15-49 mL/min per 1.73 m2 in routine clinical practice.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1700
• Est. completion date: April 4, 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Chronic Kidney Disease (CKD)
• Kidney Diseases
• Non-valvular Atrial Fibrillation (NVAF)
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Austria	Krankenhaus St. Josef Braunau	Braunau Am Inn
Austria	Medizinische Universitätsklinik	Graz
Austria	Allgemeines Krankenhaus der STadt Linz	Linz
Austria	Krankenhaus der Elisabethinen Linz	Linz
Austria	Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel	Wien
Austria	Medizinische Universität Wien	Wien
Austria	Meidzinische Universität Wien	Wien
Austria	Sozialmedizinischer Zentrum-Süd Kaiser-Franz-Josef-Spital	Wien
Belgium	Centre Hospitalier EpiCURA-Baudour	Baudour
Belgium	CUB Hôpital ERASME	Bruxelles
Belgium	CHU de Charleroi	Charleroi
Belgium	Centre Hospitalier Chrétien (CHC) St Joseph	Liège
Belgium	Centre Hospitalier Régional de la Citadelle	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
France	CH Abbeville	Abbeville
France	Clinique Sainte-Isabelle	Abbeville
France	CHU Amiens	Amiens
France	CHU Angers	Angers
France	CHU Angers	Angers
France	CH Argenteuil Centre Hospitalier Victor Dupouy	Argenteuil
France	CHU Avicenne (AP-HP)	Bobigny
France	CHU Bordeaux-Hôpital Pellegrin	Bordeaux
France	CHU Bordeaux-Hôpital Saint André	Bordeaux
France	CHRU Brest-Hôpital la Cavale Blanche	Brest
France	CH Cholet	Cholet
France	CHU Clermont Ferrand	Clermont Ferrand
France	Hôpital Louis Mourier (AP-HP)	Colombes
France	CH de Compiègne-Noyon (CHNC)	Compiègne
France	Hôpital Henri Mondor (AP-HP)	Créteil
France	CHD Vendée	La Roche sur yon
France	CHG de Chartres-Hôpital Général Louis Pasteur	Le Coudray
France	CHR Metz-Thionville, Hôpital de Mercy	Metz
France	CHU Nantes-site Hotel Dieu	Nantes
France	CHU Carémeau	Nimes
France	Claude Bernard - Bichat Hospital	Paris
France	Hôpital Bretonneau (AP-HP)	Paris
France	Pitié-Salpètrière Hospital (AP-HP)	Paris
France	CHU Nantes-Hôpital nord Laennec	Saint-Herblain
France	CHRU Strasbourg Nouvel Hôpital Civil	Strasbourg
France	CHI Toulon La Seyne sur mer - Hopital Sainte Musse	Toulon
France	Hôpital Nord Franche Comté	Trevenans
Germany	Kardiologische Praxis	Bad Homburg
Germany	Schilddrüsenzentrum Bergstrasse/Praxis Innere Medizin	Bensheim
Germany	FA für Innere Medizin	Bergisch Gladbach
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Facharzt für Allgemeinmedizin	Berlin
Germany	Franziskus-Krankenhaus Berlin	Berlin
Germany	MVZ Dres. Ramdohr	Berlin
Germany	Praxis	Berlin
Germany	Praxis Rankestrasse	Berlin
Germany	St. Joseph Krankenhaus Berlin-Tempelhof GmbH	Berlin
Germany	Vivantes Klinikum im Friedrichshain	Berlin
Germany	Studienzentrum Schwittay	Böhlen
Germany	Kardiologische Arztpraxis	Borsdorf
Germany	Städtisches Klinikum Braunschweig gGmbH	Braunschweig
Germany	Krankenhaus Buchholz	Buchholz
Germany	Gemeinschaftspraxis Kellner und Ehrhardt	Camburg
Germany	Klinikum Coburg GmbH	Coburg
Germany	Kardiologische Partnerschaftsgesellschaft	Cottbus
Germany	ZID- Zentrum für Innere Medizin Dachau	Dachau
Germany	Kardiovaskuläres Zentrum Darmstadt	Darmstadt
Germany	Kardiologie Dortmund	Dortmund
Germany	Klinikum Dortmund GmbH	Dortmund
Germany	Nephrologische Praxis	Dortmund
Germany	Gemeinschaftspraxis Dr. med. Sybille Jänsch	Dresden
Germany	Praxis Dr. med Steffen Fischer	Dresden
Germany	Praxis Dr. med. Christoph Axthelm & Kollegen	Dresden
Germany	Praxisklinik Herzkreislauf am Wasaplatz	Dresden
Germany	Universitätsklinikum Carl Gustav Carus Dresden	Dresden
Germany	Praxis Dr. med. Frank Richard	Erfurt
Germany	Klinikum Esslingen GmbH	Esslingen
Germany	Gemeinschaftspraxis im Altstadtcarree, Kardiologie	Fulda
Germany	Herzpraxis Altona	Hamburg
Germany	MVZ Prof. Mathey, Prof. Schofer GmbH	Hamburg
Germany	Zentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen	Hannover
Germany	DOKUSAN	Herne
Germany	Universitätsklinikum des Saarlandes	Homburg
Germany	Praxisnetz Dr. Haaß & Kollegen	Inden
Germany	Westpfalz-Klinikum GmbH	Kaiserslautern
Germany	Studienzentrum Dr. med. Karl-Friedrich Appel	Kassel
Germany	Gemeinschaftspraxis Wittwer, Bargemann, Baar	Kiel
Germany	Universitätsklinikum Schleswig-Holstein	Kiel
Germany	Uniklinik Köln	Köln
Germany	Praxis	Königsbrück
Germany	Gemeinschaftspraxis Scheuermann & Persicke	Kornwestheim
Germany	Eickenhof Dialyse - Gemeinschaftspraxis	Langenhagen
Germany	Klinikum St. Georg GmbH	Leipzig
Germany	Klinikum Leverkusen	Leverkusen
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz
Germany	Universitätsklinikum Marburg	Marburg
Germany	Praxis Dr. med. Jens Taggeselle	Markkleeberg
Germany	Internistisches Facharztzentrum	Memmingen
Germany	Herz-Gefäß-Zentrum Nymphenburg	München
Germany	Marienkrankenhaus Klinikum St. Elisabeth	Neuwied
Germany	Kardiologische Gemeinschaftspraxis	Nienburg
Germany	Kardiologie am Weißen Turm	Nürnberg
Germany	Klinikum Nürnberg Süd	Nürnberg
Germany	Praxis für Innere Medizin	Nürnberg
Germany	via medis Nierenzentrum Oldenburg MVZ	Oldenburg
Germany	Fachärztin für Allgemeinmedizin	Osnabrück
Germany	MVZ Birkenallee	Papenburg
Germany	Internistische Gemeinschaftspraxis	Passau
Germany	Cardiologicum Prina	Pirna
Germany	Praxis Dr. med. Christoph Axthelm & Kollegen	Pirna
Germany	Paracelsus-Harz-Klinik	Quedlinburg
Germany	KardioPrax Remscheid	Remscheid
Germany	Zentrum für Prävention und Rehabilitation	Siegen
Germany	Studienzentrum der Herzklinik Ulm GbR	Ulm
Germany	Internistische Praxis Vellmar	Vellmar
Germany	Schwarzwald-Baar-Klinikum	Villingen-Schwenningen
Germany	Gemeinschaftspraxis Drs. Grosskopf	Wallerfing
Germany	Kliniken Nordoberpfalz AG	Weiden
Germany	Praxis Dr. med. Jörg Brosche	Weinböhla
Germany	Kardiologische Praxis Dr. med. Ayham Al Zoebi	Wermsdorf
Germany	Ev. Krankenhaus Witten gGmbH	Witten
Switzerland	Kantonsspital Aarau AG	Aarau
Switzerland	Kantonsspital Baden AG	Baden
Switzerland	Klinik Hirslanden	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
GWT-TUD GmbH	ClinStat GmbH

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decline in eGFR in mL/min per 1.73 m2		12 month
Primary	major bleeding		12 month
Primary	all-cause mortality		12 month
Primary	TIA, stroke or systemic arterial embolism		12 month
Primary	major cardiovascular events (MACE)		12 month
Primary	symptomatic venous thromboembolic events		12 month
Primary	net-clinical benefit (stroke and other thromboembolic events, major bleeding, and all-cause mortality)		12 month
Secondary	initiation of chronic renal replacement therapy		12 month
Secondary	eGFR < 15 mL/min per 1.73 m2 (CKD Stage 5 Dialysis and Non-Dialysis)		12 month
Secondary	eGFR decline of = 30%		12 month
Secondary	doubling of serum creatine concentration		12 month
Secondary	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
Secondary	rates of hospitalizations		12 month, 18 month
Secondary	length of hospitalizations		12 month, 18 month
Secondary	causes of hospitalizations		12 month, 18 month
Secondary	persistence with OAC therapy		12 month, 18 month
Secondary	reasons for OAC therapy discontinuation	descriptive analysis of reasons for therapy discontinuation (verbal description by investigator)	12 month, 18 month