Anti-Xa Activity of Enoxaparin for Prevention of Venous Thromboembolism in Severe Nephrotic Syndrome. (ENOX-inNS)

Military Institute od Medicine National Research Institute

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Nephrotic Syndrome

Treatments: Drug: Enoxaparin

Study type: Interventional

Funder types: Other

Identifiers

NCT04558892

5/8952 (443)

Details and patient eligibility

About

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.

Full description

Nephrotic syndrome (NS) is a rare clinical condition characterized by proteinuria exceeding >3.5 g/24h, hypoalbuminemia, dyslipidemia and edema and is associated with hypercoagulable state. In severe cases, with serum albumin ≤2.5 g/dL, the risk of venous thromboembolic events (VTE) is particularly high, and pharmacological prophylaxis is recommended. However, there is a limited evidence of its efficacy and optimal dosing.

The study is designed as 3 arms clinical trial, with 2 study groups and a single control group. The study groups will include patients with severe NS parallelly, alternately assigned (1:1) into two enoxaparin dosing regimens. The control group will consisted of individuals without proteinuria and edema, similar in terms of age, anthropometric features and renal function to NS patients, who will be administered a standard enoxaparin dose. A peak anti-Xa activity at the steady state will be measured to determine the plasma concentration of enoxaparin. Additional laboratory tests for markers of NS severity, renal function and coagulation system proteins will be performed. The overhydration and body water compartments will be assessed using bioimpedance spectroscopy technique. Nephrotic patients will be followed up by 12 months to assess overt VTE and adverse events associated with enoxaparin use.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 3 patient groups

Nephrotic syndrome - fixed dose (NS-FD)

Experimental group

Description:

Drug: Enoxaparin; Dose: 40 mg; Administration: once daily subcutaneously.

Treatment:

Drug: Enoxaparin

Nephrotic syndrome - adjusted dose (NS-AD)

Experimental group

Description:

Drug: Enoxaparin; Dose: 1 mg/kg of ideal body weight; Administration: once daily subcutaneously.

Treatment:

Drug: Enoxaparin

Control - fixed dose (C-FD)

Active Comparator group

Description:

Drug: Enoxaparin; Dose: 40 mg; Administration: once daily subcutaneously.

Treatment:

Drug: Enoxaparin