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Nephrotic SyndromeNCT07116239

Edoxaban Steady-State PK/PD in Adults With Nephrotic Syndrome

A study testing Edoxaban 60 mg and Enoxaparin 40 mg in people with Nephrotic Syndrome and Hypoalbuminemia, run by Peking University People's Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

A study to evaluate the impact of nephrotic syndrome on the steady state pharmacokinetics and pharmacodynamics of edoxaban compared to health volunteers, and whether edoxaban can provide an equivalent anticoagulant effect to enoxaparin sodium. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Nephrotic Syndrome, Hypoalbuminemia
What is being tested?
Edoxaban 60 mg and Enoxaparin 40 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Sep 2025to Feb 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Nephrotic syndrome Group:
  • Age between 18-70 years old
  • Diagnosed with nephrotic syndrome: proteinuria≥3.5 g/24h or morning urine protein/creatinine ratio ≥3.0g/g), with serum albumin <30g/L present at the time of enrollment, with or without edema or hyperlipidemia
  • Calculated creatinine clearance (CrCl) >50ml/min using the Cockcroft-Gault formula
  • Actual body weight >60kg, and body mass index within the range of 18.5-28kg/m2
  • Signed informed consent form
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  • Healthy volunteer Group:
  • Age between 18-70 years old
  • Serum albumin ≥40g/L
  • Calculated CrCl >50ml/min using the Cockcroft-Gault formula
  • Actual body weight >60kg, and body mass index within the range of 18.5-28kg/m2
  • Signed informed consent form

Who cannot join

  • Serun albumin <30 g/L for other reasons in patients with nephrotic syndrome as judged by the investigator
  • Prolonged PT, INR, APTT at baseline (defined as greater than the upper limit of normal values)
  • Platelet count <100×109/L or ≥300×109/L due to hematological diseases confirmed by laboratory tests
  • History of: gastrointestinal bleeding, intracranial hemorrhage, hemoptysis, or other clinically documented bleeding from internal organs within the last 3 months; surgery (except >3 days after renal biopsy without bleeding complications) or trauma. Bleeding complications after renal biopsy are defined as: ① bleeding (hematuria, perirenal hematoma, or arteriovenous fistula) that occur after renal biopsy requiring transfusion, resulting in altered hemodynamics, or requiring surgery or interventional treatment; ② symptomatic perirenal hematoma; and ③visible hematuria that persist for >3 days postoperatively.
  • A lesion or condition with a significant risk of major bleeding, such as current or recent gastrointestinal ulcer, malignant tumors with a high risk of bleeding, esophageal varices, arteriovenous malformations, vascular aneurysms, or major intravertebral or intracerebral vascular malformations.
  • Serious bleeding disorders as judged by the investigator
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  • Systemic lupus erythematosus with or without renal damage
  • Bleeding or thrombophilia disorders as judged by the investigator
  • History of stroke
  • History of congestive heart failure (New York grade II or above) at the time of screening
  • Liver dysfunction (cirrhosis or bilirubin >2×, and serum transaminases >3×, upper limit of normal)
  • Use of (but not limited to) the prescription medications that are inhibitors or inducers of CYP3A4 and/or P-gp within the past 14 days:
  • CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, etc.) ②CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, etc.)
  • P-gp inducers (e.g., apalutamide, rifampicin, etc.) ④ P-gp inhibitors (e.g., dronedarone, cyclosporine, erythromycin, ketoconazole, quinidine, verapamil, amiodarone, etc.) ⑤Selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)
  • Use of antiplatelet and/ or anticoagulant agents within 5 half-lives (at least 7 days): including but not limited to heparin, heparin derivatives, aspirin, clopidogrel, prasugrel, nonsteroidal anti-inflammatory drugs, warfarin, rivaroxaban, dabigatran, apixaban, etc.
  • Pregnant or breastfeeding women or women of childbearing age without contraception
  • Uncontrolled severe hypertension (SBP≥180mmHg, DBP≥110mmHg)
  • Conditions considered unsuitable for inclusion in this study, judged by investigator
  • Patients with hypersensitivity to the active ingredient or other excipients of the Edoxaban and enoxaparin sodium
  • History of immune-mediated heparin-induced thrombocytopenia (HIT) or presence of circulating antibodies within the previous 100 days.
  • Spinal or epidural anesthesia or local anesthesia within 24 hours prior to the administration of enoxaparin sodium and Edoxaban

About this study

Official title: Steady-state Pharmacokinetics and Pharmacodynamics of Edoxaban in Adults With Nephrotic Syndrome: A Non-randomized Open-label, Parallel Arm and Single-center Study

A study to evaluate the impact of nephrotic syndrome on the steady state pharmacokinetics and pharmacodynamics of edoxaban compared to health volunteers, and whether edoxaban can provide an equivalent anticoagulant effect to enoxaparin sodium.

Being tested
Edoxaban 60 mg, Enoxaparin 40 mg
Keywords
edoxaban, nephrotic syndrome, hypoalbuminemia, enoxaparin
Medical subject headings
Nephrotic Syndrome, Hypoalbuminemia

What participants receive

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

  • Edoxaban 60 mgDrug

    Also called LIXIANAN

    film-coated tablet, manufactured by Daiichi Sankyo Europe GmbH

  • Enoxaparin 40 mgDrug

    Also called CLEXANE

    enoxaparin sodium, prefilled syringe of 0.4mL injectable solution, manufactured by SANOFI WINTHROP INDUSTRIE

Study groups in NCT07116239
Study groupRoleWhat they receive
Edoxaban NS Group 1ExperimentalPatients with mild hypoalbuminemia (serum albumin >25g/L and <30g/L), taking edoxaban 60mg orally once daily
Receives: Drug: Edoxaban 60 mg
Edoxaban NS Group 2ExperimentalPatients with severe hypoalbuminemia (serum albumin ≤25g/L), taking edoxaban 60mg orally once daily
Receives: Drug: Edoxaban 60 mg
LMWH NS Group 1Active comparatorPatients with mild hypoalbuminemia (serum albumin >25g/L and <30g/L), injecting enoxaparin sodium 0.4ml subcutaneously once daily
Receives: Drug: Enoxaparin 40 mg
LMWH NS Group 2Active comparatorPatients with severe hypoalbuminemia (serum albumin ≤25g/L), injecting enoxaparin sodium 0.4ml subcutaneously once daily
Receives: Drug: Enoxaparin 40 mg
Healthy Volunteer GroupOtherHealthy volunteers, taking edoxaban 60mg orally once daily
Receives: Drug: Edoxaban 60 mg

What is being measured

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

  1. area under the steady-state plasma concentration-time curve (AUCss)

    ① Steady-state PK parameters of edoxaban in nephrotic syndrome patients versus healthy volunteers: area under the steady-state plasma concentration-time curve (AUCss)

    Measured: Day 4 post-administation

  2. time to peak (Tmax)

    Steady-state PK parameters of edoxaban in nephrotic syndrome patients versus healthy volunteers: time to peak (Tmax)

    Measured: Day 4 post-administation

  3. trough concentration at steady state (Css_min)

    Steady-state PK parameters of edoxaban in nephrotic syndrome patients versus healthy volunteers: trough concentration at steady state (Css_min)

    Measured: Day 4 post-administation

  4. peak concentration at steady state (Css_max)

    Steady-state PK parameters of edoxaban in nephrotic syndrome patients versus healthy volunteers: peak concentration at steady state (Css_max)

    Measured: Day 4 post-administation

  5. elimination half-life (t1/2)

    Steady-state PK parameters of edoxaban in nephrotic syndrome patients versus healthy volunteers: elimination half-life (t1/2)

    Measured: Day 4 post-administation

  6. average steady-state plasma concentration (Css_av)

    Steady-state PK parameters of edoxaban in nephrotic syndrome patients versus healthy volunteers: average steady-state plasma concentration (Css_av)

    Measured: Day 4 post-administation]

  7. apparent volume of distribution (Vd/F)

    Steady-state PK parameters of edoxaban in nephrotic syndrome patients versus healthy volunteers: apparent volume of distribution (Vd/F)

    Measured: Day 4 post-administation

  8. clearance (CL/F)

    Steady-state PK parameters of edoxaban in nephrotic syndrome patients versus healthy volunteers: clearance (CL/F)

    Measured: Day 4 post-administation

  9. anti-FXa activity

    Steady-state PD parameters of edoxaban versus enoxaparin in nephrotic syndrome patients: anti-FXa activity

    Measured: Day 4 post-administation

  10. prothrombin time (PT)

    Steady-state PD parameters of edoxaban versus enoxaparin in nephrotic syndrome patients: prothrombin time (PT)

    Measured: Day 4 post-administation

  11. activated partial thromboplastin time(APTT)

    Steady-state PD parameters of edoxaban versus enoxaparin in nephrotic syndrome patients: activated partial thromboplastin time(APTT)

    Measured: Day 4 post-administation

  12. antithrombin Ⅲ(AT-III)

    Steady-state PD parameters of edoxaban versus enoxaparin in nephrotic syndrome patients: antithrombin Ⅲ(AT-III)

    Measured: Day 4 post-administation

  13. Protein C

    Steady-state PD parameters of edoxaban versus enoxaparin in nephrotic syndrome patients: Protein C

    Measured: Day 4 post-administation

  14. Protein S

    Steady-state PD parameters of edoxaban versus enoxaparin in nephrotic syndrome patients: Protein S

    Measured: Day 4 post-administation

  15. D-Dimer

    Steady-state PD parameters of edoxaban versus enoxaparin in nephrotic syndrome patients: D-Dimer

    Measured: Day 4 post-administation

Timeline

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

  1. First posted11 Aug 2025
  2. Study startSep 2025 (estimated)
  3. Primary completionFeb 2026 (estimated)
  4. Study completionFeb 2026 (estimated)

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 N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07116239
Sponsor's protocol ID
2025-h009
Status last verified
Aug 2025
First submitted
25 Jul 2025
Last updated
11 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Edoxaban 60 mg and Enoxaparin 40 mg in people with Nephrotic Syndrome and Hypoalbuminemia, run by Peking University People's Hospital.

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 12 inclusion and 21 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: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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 steady-state plasma concentration-time curve (AUCss) (time frame: Day 4 post-administation). The study lists 15 primary outcomes in all. 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 NCT07116239.

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 11 Aug 2025.

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