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
Qualifiers
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
Treatments tested in this trial
- Edoxaban 60 mg
- Enoxaparin 40 mg
Treatment groups
60 Participants
are divided into 5 treatment groupsLocations
Sponsors and collaborators
Peking University People's Hospital
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborator
Source ClinicalTrials.gov