A Prospective Multi-dose Study of Apixaban in Subjects With Nephrotic Syndrome

  • End date
    Jun 3, 2022
  • participants needed
  • sponsor
    University of North Carolina, Chapel Hill
Updated on 3 September 2021
chronic kidney disease


This phase I study is a single arm, multi-dose study that will evaluate steady-state apixaban pharmacokinetics (PK) and pharmacodynamics (PD) in subjects with Nephrotic Syndrome (NS) vs healthy control subjects. This study will enroll 20 subjects diagnosed with NS and 10 healthy control subjects. Comparing differences in steady-state apixaban PK/PD parameters between subjects with NS and healthy volunteers will be essential to identifying a safe and effective apixaban dose and dose administration schedule for future randomized controlled trials (RCTs).

Condition Idiopathic Membranous Nephropathy, Membranous glomerulonephritis, membranous nephropathy, Glomerulonephritis, Nephrotic Syndrome, Autoimmune Disease, Autoimmune disease
Treatment Apixaban 5 mg
Clinical Study IdentifierNCT04278729
SponsorUniversity of North Carolina, Chapel Hill
Last Modified on3 September 2021


Yes No Not Sure

Inclusion Criteria

Study Subjects
-79 years of age
Confirmed diagnosis of NS, with at least one of the following (confirmed within 1 month prior to scheduled Day 1 Study Visit)
Nephrotic-range proteinuria, defined as >3.0 g/24 hours
UPC (ratio of protein to creatinine in random spot urine sample), defined as >3.0
Hypoalbuminemia, defined as <3.0 g/dL
Control Subjects
-79 years of age
Normal albumin levels (>3.0 mg/dL)
No history of chronic kidney disease

Exclusion Criteria

Age <18 or 80 years old
Serum Creatinine (SCr) 1.5 AND weight 60kg (these subjects would receive a reduced apixaban dose, per drug labeling)
Weight >120 kg OR body mass index (BMI) 40 kg/m^2
Estimated Glomerular Filtration Rate (eGFR) <15 mL/min or on dialysis
Signs and symptoms of increased risk of bleeding, including but not limited to: frequent nosebleeds, unexplained or worsening bruising, blood in urine or stool
Unwilling to avoid engaging in activities that may increase the risk of bleeding through body injury or bruising, during the study period (e.g., contact sports)
Baseline prolonged INR, defined as INR >1.4
If INR is elevated, but PT and aPTT are below the upper limit of normal (13.3 sec and 37.7 sec, respectively), then the subject may be cleared to receive the study drug at the discretion of one of the study physicians
Platelets <100 x 109/L
History of stroke, or a history of gastrointestinal or intracranial bleeds
Use of any prescription medications, over-the-counter (OTC) medications, or herbal products that are strong inhibitors or inducers of CYP3A4 and/or P-gp within 14 days prior to Study Day 1 or anticipated need for such drugs during the study. Examples
Strong inducers of CYP3A4 (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort, etc.)
Strong inhibitors of CYP3A4 (e.g., ketoconazole, ritonavir, clarithromycin, etc.)
Antiplatelet and/or anticoagulant agents: heparin, aspirin (see below), clopidogrel, prasugrel, non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, rivaroxaban, dabigatran, edoxaban
Pregnancy or breastfeeding
Liver disease with impaired synthetic function (INR >1.4, total bilirubin >1.2)
Evidence of acute kidney disease by the KDIGO criteria (>1.5 x baseline SCr, or >0.3 mg/dL increase in SCr, over past 48 hours
Unwillingness to forgo drinking alcohol during the study period due to heightened bleeding risk
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note