Loading clinical trials...

Edoxaban Steady-State PK/PD in Adults With Nephrotic Syndrome | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

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

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

NCT07116239•Peking University People's Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. 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
•2. Healthy volunteer Group:
•* Age between 18-70 years old
•* Serum albumin ≥40g/L
•* Calculated CrCl \>50ml/min using the Cockcroft-Gault formula
+2 more criteria

Exclusion Criteria

•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
•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
+11 more criteria

Key Dates

Start Date

September 1, 2025

Primary Completion Date

February 1, 2026

Completion Date

February 1, 2026

Last Updated

August 11, 2025

Enrollment

ESTIMATED participants

Conditions

Nephrotic SyndromeHypoalbuminemia

Interventions

Edoxaban 60 mg

DRUG

Enoxaparin 40 mg

DRUG

Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.

NCT05505500

Fluid OverloadGlomerulosclerosis, Focal Segmental+11 more

View study

RECRUITINGPHASE2

Effect of Goal-Oriented Albumin Infusion on Postoperative Complication Management in Gastric Cancer Surgery

NCT07119463

Postoperative HypoalbuminemiaPostoperative Complications+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.

Effect of Goal-Oriented Albumin Infusion on Postoperative Complication Management in Gastric Cancer Surgery

Blinatumomab for CNI-Resistant/Intolerant SRNS in Children

REduced-dose Steroid PrOtocol for Childhood Nephrotic SyndromE (RESPONSE)

Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome

National Registry of Rare Kidney Diseases