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

  • STATUS
    Recruiting
  • End date
    Jun 3, 2022
  • participants needed
    30
  • sponsor
    University of North Carolina, Chapel Hill
Updated on 3 September 2021
chronic kidney disease
proteinuria
apixaban
mammogram
hypoalbuminemia

Summary

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).

Details
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

Eligibility

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
included
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
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