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.