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Can Rivaroxaban Lead to Anticoagulation-Related Nephropathy?

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ClinicalTrials.gov Identifier: NCT02900170
Recruitment Status : Unknown
Verified June 2017 by Basma Abdulhadi, Albert Einstein Healthcare Network.
Recruitment status was:  Recruiting
First Posted : September 14, 2016
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Basma Abdulhadi, Albert Einstein Healthcare Network

Brief Summary:

Anticoagulation-Related Nephropathy (ARN) is a side effect of treatment with blood thinners which leads to kidney dysfunction. A recent review suggests that kidney function should be assessed (by measuring serum creatinine) serially in the first few months of starting a blood thinner. ARN is diagnosed when there is a decline in kidney function after starting the blood thinner and other possible causes of this decline have been excluded. ARN has mainly been studied in relation to the common blood thinner - warfarin, where the prevalence is variable but can be as high as 37% (approximately 1 in 3) in the patients at highest risk. The risk factors that make this side effect more likely include the presence of pre-existing kidney disease, high blood pressure, older age and diabetes mellitus. Studies have shown that the occurence of ARN can lead to an accelerated progression of pre-existing kidney disease and a 65% increase in the risk of death (mortality).

The non-vitamin K oral anticoagulants (NOACs) are a new group of drugs which have been recently approved for use as blood thinners. They have a faster onset of action compared to warfarin and unlike warfarin, they do not need frequent monitoring. Rivaroxaban is the most commonly prescribed NOAC at Einstein Medical Center Philadelphia. There are some case reports that other NOACs (such as dabigatran and apixaban) can lead to ARN, however there is no study that has determined the true incidence of ARN in NOACs. Our study is designed to find out the incidence of ARN in patients who are started on rivaroxaban.

The investigators intend to serially monitor the kidney function of 40 high risk patients who are recently started on rivaroxaban over a six month period. This will enable us to discover how many patients actually develop ARN after starting a NOAC. The information the investigators will obtain from this study will enable patients and health care providers make better decisions about using blood thinners. If the investigators find that the incidence of ARN with rivaroxaban is less common than that previously reported with warfarin, it can potentially make more patients use the NOACs and hence save them from the morbidity and mortality associated with ARN. Our study is unique because this will be the first study focused on ARN in one of the new blood thinners. The information the investigators get from this study will be a very important foundation for future studies.


Condition or disease
Acute Kidney Injury

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can Rivaroxaban Lead to Anticoagulation-Related Nephropathy?
Study Start Date : July 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban




Primary Outcome Measures :
  1. Incidence of anticoagulant-related nephropathy in the cohort [ Time Frame: 6 months ]
    Primary endpoint - Incidence of ARN is the primary outcome of this study and this is based on a documentation of AKI (defined as an increase in baseline serum creatinine ≥ 0.3 mg/dL), in the absence of any other obvious etiology for the AKI identified after a standard clinical evaluation and work up by the patient's primary care physician, cardiologist or nephrologist. This incidence will be expressed as a percentage.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This is a prospective observational study designed to determine the incidence of ARN in 40 adult patients recently initiated on rivaroxaban at Einstein Medical Center Philadelphia.
Criteria

Inclusion Criteria:

  • Age ≥ 60 years
  • GFR ≤ 60 ml/L based on creatinine clearance
  • Participant has been initiated on long term anticoagulation with rivaroxaban for atrial fibrillation within four weeks of recruitment

Exclusion Criteria:

  • History of blood dyscrasias or active bleeding,
  • History of hematuria
  • Patients on dialysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900170


Contacts
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Contact: Basma Abdulhadi, MD 215 301 2044 abdulhab@einstein.edu

Locations
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United States, Pennsylvania
Einstein Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Basma Abdulhadi, MD       abdulhab@einstein.edu   
Sponsors and Collaborators
Albert Einstein Healthcare Network
Investigators
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Principal Investigator: Basma Abdulhadi, MD Einstein Medical Center

Publications of Results:

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Responsible Party: Basma Abdulhadi, Medical Resident, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT02900170    
Other Study ID Numbers: 4831
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Basma Abdulhadi, Albert Einstein Healthcare Network:
Rivaroxaban, Acute Kidney Injury
Additional relevant MeSH terms:
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Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Renal Insufficiency
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants