Edoxaban Steady-State PK/PD in Adults With Nephrotic Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPeking University People's Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Edoxaban 60 mg
Drugfilm-coated tablet, manufactured by Daiichi Sankyo Europe GmbH
Enoxaparin 40 mg
Drugenoxaparin sodium, prefilled syringe of 0.4mL injectable solution, manufactured by SANOFI WINTHROP INDUSTRIE
Treatment groups
60 Participants
are divided into 5 treatment groupsGroup A: Edoxaban NS Group 1Experimental treatment 1 intervention
Group B: Edoxaban NS Group 2Experimental treatment 1 intervention
Group C: LMWH NS Group 1Active comparator 1 intervention
Group D: LMWH NS Group 2Active comparator 1 intervention
Group E: Healthy Volunteer GroupOther 1 intervention
Trial outcomes
Primary outcomes
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)
Time frame
Day 4 post-administation2
time to peak (Tmax)
Steady-state PK parameters of edoxaban in nephrotic syndrome patients versus healthy volunteers: time to peak (Tmax)
Time frame
Day 4 post-administation3
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)
Time frame
Day 4 post-administation4
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)
Time frame
Day 4 post-administationOther outcomes
1
Safety Assessment
Adverse events will be collected and coded according to the Medical Dictionary for Regulatory Activities (MedDRA)
Time frame
from the date of informed consent form signature to day 8 post-administrationLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University People's Hospital
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborator
Source ClinicalTrials.gov
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