Overview

Anti-Xa Activity of Enoxaparin for Prevention of Venous Thromboembolism in Severe Nephrotic Syndrome.

Status:
Terminated
Trial end date:
2018-11-30
Target enrollment:
0
Participant gender:
All
Summary
The primary objective is to test the hypothesis that enoxaparin efficacy is reduced in severe nephrotic syndrome. Another purpose is to compare two dosing regimens.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Military Institute of Medicine, Poland
Treatments:
Enoxaparin
Criteria
Inclusion Criteria:

- Severe NS, defined as proteinuria exceeding 3.5 g/24h or 50 mg/kg/24h and serum
albumin ≤2.5 g/dL;

- eGFR ≥30 mL/min/1.73 m2.

Exclusion Criteria:

- Body mass index (BMI) ≥40 kg/m2;

- Low body mass (<45 kg for female, <57 kg for male);

- Acute VTE;

- Previously introduced anticoagulation (due to comorbidities);

- Contraindications for enoxaparin;

- Pregnancy.