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

NCT ID: NCT04558892

Last Updated: 2023-01-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-01
• Study Completion Date: 2018-11-30

Brief 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.

Detailed 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.

Conditions

Nephrotic Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Nephrotic syndrome - fixed dose (NS-FD)

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

Group Type: EXPERIMENTAL

Enoxaparin

Intervention Type: DRUG

Nephrotic syndrome - adjusted dose (NS-AD)

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

Group Type: EXPERIMENTAL

Enoxaparin

Intervention Type: DRUG

Control - fixed dose (C-FD)

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

Group Type: ACTIVE_COMPARATOR

Enoxaparin

Intervention Type: DRUG

Interventions

Enoxaparin

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Military Institute od Medicine National Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Anna Matyjek

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Matyjek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Military Institute of Medicine

Locations

Military Institute of Medicine

Warsaw, Masovian District, Poland

Countries

Poland

References

Matyjek A, Rymarz A, Nowicka Z, Literacki S, Rozmyslowicz T, Niemczyk S. Anti-Xa Activity of Enoxaparin for Prevention of Venous Thromboembolism in Severe Nephrotic Syndrome-A Single Center Prospective Study. J Clin Med. 2021 Dec 6;10(23):5709. doi: 10.3390/jcm10235709.

Reference Type: RESULT

PMID: 34884411 (View on PubMed)

Other Identifiers

5/8952 (443)

Identifier Type: -

Identifier Source: org_study_id