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Nephrotic SyndromePhase 1NCT04278729

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

A Phase 1 study testing Apixaban 5 MG in people with Nephrotic Syndrome and Membranous Nephropathy, 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 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. 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, Membranous Nephropathy
What is being tested?
Apixaban 5 MG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
14 Apr 2021to 22 Sep 2023
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
  • 18-79 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
Show all 10Show fewer
  • Control Subjects
  • 18-79 years of age
  • Normal albumin levels (>3.0 mg/dL)
  • No history of chronic kidney disease

Who cannot join

  • 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)
Show all 18Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27517

Other trials in United States

About this study

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).

Being tested
Apixaban 5 MG
Medical subject headings
Nephrotic Syndrome, Glomerulonephritis, Membranous

What participants receive

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

  • Apixaban 5 MGDrug

    Also called Eliquis

    1 - 5 mg tablet taken orally twice a day

Study groups in NCT04278729
Study groupRoleWhat they receive
Nephrotic Syndrome ArmExperimentalPatients diagnosed with Nephrotic syndrome will be in this arm.
Receives: Drug: Apixaban 5 MG
Healthy ArmExperimentalHealthy volunteers will be in this arm.
Receives: Drug: Apixaban 5 MG

What is being measured

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

  1. Steady-state Area Under the Plasma Concentration Versus Time Curve From Time Zero to 12 Hours of Apixaban

    Area Under the Curve (AUC (0-12)) is the area under the curve from time 0 to 12 hour after apixaban steady state concentration is reached.

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

Secondary outcomes (18)

  1. Initial Dose Area Under the Plasma Concentration Versus Time Curve From Time Zero to 12 Hours of Apixaban

    AUC (0-12) is the area under the curve from time 0 to 12 hour after the initial dose

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

  2. Steady state Elimination of Half-Life of Apixaban

    Mean terminal phase plasma t½ of apixaban at steady-state

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

  3. Initial dose Elimination of Half-Life of Apixaban

    Mean terminal phase plasma t½ of apixaban after initial dose

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

  4. Steady-state Maximum Observed Plasma Concentration of Apixaban

    Maximum observed drug concentration in plasma after administration (Cmax) of apixaban at steady-state

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

  5. Initial dose Maximum Observed Plasma Concentration of Apixaban

    Maximum observed drug concentration in plasma after administration (Cmax) of apixaban after initial dose

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

  6. Steady state Plasma Clearance as a Function of Bioavailability of Apixaban

    CL/F of apixaban of apixaban at steady-state

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

  7. Initial dose Plasma Clearance (CL) as a Function of Bioavailability (F) of Apixaban

    CL/F of apixaban of apixaban after initial dose

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

  8. Initial Thrombin Generation Assay (TGA)

    Initial apixaban TGA concentrations. Thrombin generation assay is used to investigate hypo- or hypercoagulability.

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

  9. Steady state Thrombin Generation Assay (TGA)

    Steady state apixaban TGA concentrations. Thrombin generation assay is used to investigate hypo- or hypercoagulability.

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

  10. Initial dose Anti-Xa activity

    Initial apixaban dose Anti-Xa activity. Anti-Xa activity will be used to measure plasma apixaban levels.

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

  11. Steady state Anti-Xa activity

    Steady state apixaban dose Anti-Xa activity. Anti-Xa activity will be used to measure plasma apixaban levels.

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

  12. Initial dose Activated Partial Thromboplastin Time (aPTT)

    Initial apixaban dose aPTT. The activated partial thromboplastin time (aPTT) will be used to characterize the coagulation of the blood.

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

  13. Steady state Activated Partial Thromboplastin Time (aPTT)

    Steady state apixaban dose aPTT. The activated partial thromboplastin time (aPTT) will be used to characterize the coagulation of the blood.

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

  14. Initial dose International Normalised Ratio (INR)

    Initial apixaban dose INR. INR is defined as the ratio of the participants prothrombin time and the normal mean prothrombin time. The INR will help determine the risk of coagulation.

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

  15. Steady state International Normalised Ratio (INR)

    Steady state apixaban dose INR. INR is defined as the ratio of the participants prothrombin time and the normal mean prothrombin time. The INR will help determine the risk of coagulation.

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

  16. Initial dose Prothrombin time (PT)

    Initial apixaban dose PT. Prothrombin is defined as time taken by the blood to clot in the participants.

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

  17. Steady state Prothrombin time (PT)

    Steady state apixaban dose PT. Prothrombin is defined as time taken by the blood to clot in the participants.

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

  18. Total Adverse Events (AE)

    Number of subjects experiencing AEs, bleeding-related AEs, serious adverse events (SAEs), or discontinuations due to AEs

    Measured: From screening to Day 10 after initial study drug administration

Timeline

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

  1. First posted20 Feb 2020
  2. Study start14 Apr 2021
  3. Primary completion22 Sep 2023
  4. Study completion22 Sep 2023

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04278729
Sponsor's protocol ID
18-2233
Status last verified
Sep 2023
First submitted
18 Feb 2020
Last updated
26 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Apixaban 5 MG in people with Nephrotic Syndrome and Membranous Nephropathy, 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 10 inclusion and 18 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 26 Sep 2023. 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?

Steady-state Area Under the Plasma Concentration Versus Time Curve From Time Zero to 12 Hours of Apixaban (time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose approximately on Day 8). 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 NCT04278729.

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 26 Sep 2023.

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