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Nephrotic SyndromePhase 1NCT02599532

Pharmacokinetics of Apixaban in Nephrotic Syndrome

A Phase 1 study testing apixaban in people with Nephrotic Syndrome and Proteinuria, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to investigate the pharmacokinetics and pharmacodynamics of apixaban in nephrotic syndrome. Read more about this study

Who is it for?
Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Nephrotic Syndrome, Proteinuria
What is being tested?
apixaban
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
30 Apr 2017to 28 Jun 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Study subjects:
  • Between 18 and 79 years old
  • Confirmed diagnosis of Nephrotic Syndrome, with at least one of the following:
  • 1. Nephrotic-range proteinuria, defined as >3.5 g/24 hours or UPC >3.5 (confirmed within 1 month prior to scheduled study visit)
  • 2. Hypoalbuminemia, defined as <3 g/dL (confirmed within 1 month prior to scheduled study visit)
  • Control subjects:
Show all 9Show fewer
  • Between 18 and 79 years old
  • Normal albumin levels (≥3.5 mg/dL)
  • No proteinuria (UPC <0.15)

Who cannot join

  • Age <18 or ≥ 80 years old
  • SCr ≥ 1.5 AND weight ≤ 60kg (these subjects would receive a reduce dose of apixaban, per drug labeling)
  • On dialysis
  • Baseline prolonged PT/INR, PTT (as defined by greater than the upper limit of normal)
  • INR will be used as the primary lab value to evaluate bleeding risk (e.g. a patient presenting with an INR within normal limits, but prolonged PT or PTT, will not meet this exclusion criterion and will still be eligible for the study)
  • Reference Ranges
Show all 26Show fewer
  • INR: >1.4
  • PT: >13.3 sec
  • aPTT: >37.7 sec
  • Platelets <100
  • History of GI bleed
  • History of intracranial bleed
  • History of stroke
  • Use of (but not limited to) the following medications within the past 14 days:
  • 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, NSAIDs, warfarin, rivaroxaban, dabigatran, edoxaban
  • Selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)
  • Pregnancy/breastfeeding
  • Liver disease with impaired synthetic function (INR >1.4, total bilirubin >1.2)
  • Congestive heart failure
  • Special consideration for patients on aspirin: for patients on chronic low-dose aspirin therapy, we will allow a 7 day wash out period. This will only be allowed for patients who are taking aspirin as primary prophylaxis or for unclear indications. Patients who are on aspirin therapy for following indications will be excluded: primary prophylaxis of stroke due to atrial fibrillation, secondary prevention of stroke or myocardial infarction, history of coronary artery disease or peripheral vascular disease. For patients who meet the potential criteria for the 7-day wash out, their medical history will be reviewed by one of the clinician investigators to ensure that it is safe and appropriate to hold the agent.
  • Those subjects taking aspirin for the following reasons will be excluded:
  • Primary stroke prevention from atrial fibrillation
  • Secondary prevention due to prior stroke, heart attack or cardiac stent
  • Existing heart disease or peripheral vascular disease.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

This study is to investigate the pharmacokinetics and pharmacodynamics of apixaban in nephrotic syndrome.

Read the detailed description

Nephrotic syndrome (NS) is characterized by proteinuria and hypoalbuminemia, and patients with nephrotic syndrome are known to be hypercoaguable with increased incidence of venous thromboembolism necessitating anticoagulation. While classically warfarin has been used as an anticoagulant in NS, newer oral anticoagulants, such as apixaban, are increasingly used to treat venous thromboembolism (VTE) in the general population. It is unknown how hypoalbuminemia and proteinuria affect the pharmacokinetics and pharmacodynamics of apixaban.

This will be a parallel arm, single-dose pilot study of the pharmacokinetics of apixaban in adults with nephrotic syndrome. Goal enrollment of twenty subjects with non-diabetic nephropathy who have nephrotic-range proteinuria, defined as >3.5g/24 hours or UPC >3.5 and ten healthy control subjects without nephrotic syndrome. Each subject will be administered a single dose of apixaban 10 mg. Plasma drug concentration level and plasma anti-Xa activity levels will be measured at 0, 0.5, 1, 3, 4, 6, 8, 24 hours after drug administration in order to determine the maximum plasma concentration of apixaban, area under the curve, and half-life of apixaban in the setting of hypoalbuminemia and proteinuria due to nephrotic syndrome. Apixaban levels will be measured via liquid-chromatography spectrometry mass. Additionally, thrombin generation will be measured at 0, 3, 6, and 24 hours.

Being tested
apixaban
Keywords
Apixaban, Pharmacokinetics, Pharmacodynamics
Medical subject headings
Nephrotic Syndrome, Proteinuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • apixabanDrug

    Also called Eliquis

    Study subjects will be given a single-dose of apixaban 10 mg.

Study groups in NCT02599532
Study groupRoleWhat they receive
Nephrotic syndromeOtherSubjects with nephrotic syndrome will receive a single dose of apixaban 10 mg and will subsequently have blood drawn at 0, 0.5, 1, 3, 4, 6, 8, 24 hours after drug administration.
Receives: Drug: apixaban
Non-nephrotic syndromeOtherSubjects without nephrotic syndrome will receive a single dose of apixaban 10 mg and will subsequently have blood drawn at 0, 0.5, 1, 3, 4, 6, 8, 24 hours after drug administration.
Receives: Drug: apixaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the concentration versus time curve after single dose (AUC) of apixaban

    Measured: Predose; 0.5, 1, 3, 4, 6, and 8 hours (hr) postdose on Day 1; 24 hours postdose on Day 2

Secondary outcomes (5)

  1. Mean terminal phase plasma half-life (t½)

    Measured: Predose; 0.5, 1, 3, 4, 6, and 8 hours postdose on Day 1; 24 hours postdose on Day 2

  2. Apparent oral clearance (CL/F)

    Measured: Predose; 0.5, 1, 3, 4, 6, and 8 hours postdose on Day 1; 24 hours postdose on Day 2

  3. Maximum observed drug concentration in plasma after single dose administration (Cmax)

    Measured: Predose; 0.5, 1, 3, 4, 6, and 8 hours postdose on Day 1; 24 hours postdose on Day 2

  4. Thrombin Generation Assay

    Measured: Predose; 3 and 6 hours postdose on Day 1; 24 hours postdose on Day 2

  5. Anti-Xa activity

    Measured: Predose; 0.5, 1, 3, 4, 6, and 8 hours postdose on Day 1; 24 hours postdose on Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2015 (estimated)
  2. Study start30 Apr 2017
  3. Primary completion28 Jun 2019
  4. Study completion28 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02599532
Sponsor's protocol ID
14-1455
Other IDs
550KR161709
Status last verified
Jul 2019
First submitted
4 Nov 2015
Last updated
24 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing apixaban in people with Nephrotic Syndrome and Proteinuria, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the concentration versus time curve after single dose (AUC) of apixaban (time frame: Predose; 0.5, 1, 3, 4, 6, and 8 hours (hr) postdose on Day 1; 24 hours postdose on Day 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02599532.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.

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