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Completed

NCT Number: NCT02663076

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

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.

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Key information

Conditions

Non-valvular Atrial Fibrillation (NVAF) Chronic Disease Chronic Kidney Disease (CKD) Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Krankenhaus St. Josef Braunau, Braunau am Inn, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 12 month

  2. major bleeding

    Time frame: 12 month

  3. all-cause mortality

    Time frame: 12 month

  4. TIA, stroke or systemic arterial embolism

    Time frame: 12 month

  5. major cardiovascular events (MACE)

    Time frame: 12 month

  6. symptomatic venous thromboembolic events

    Time frame: 12 month

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

    Time frame: 12 month

Secondary outcomes

  1. initiation of chronic renal replacement therapy

    Time frame: 12 month

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

    Time frame: 12 month

  3. eGFR decline of ≥ 30%

    Time frame: 12 month

  4. doubling of serum creatine concentration

    Time frame: 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

    Time frame: 12 month, 18 month

  6. rates of hospitalizations

    Time frame: 12 month, 18 month

  7. length of hospitalizations

    Time frame: 12 month, 18 month

  8. causes of hospitalizations

    Time frame: 12 month, 18 month

  9. persistence with OAC therapy

    Time frame: 12 month, 18 month

  10. reasons for OAC therapy discontinuation

    Time frame: 12 month, 18 month

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

Sponsors and collaborators

Lead sponsor

GWT-TUD GmbH

Other

Collaborators

  • ClinStat GmbH

Registry information

Acronym: XARENO

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2016
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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