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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04558892
Other study ID # 5/8952 (443)
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
Start date October 1, 2015
Est. completion date November 30, 2018

Study information

Verified date September 2020
Source Military Institute of Medicine, Poland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 65
Est. completion date November 30, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Enoxaparin


Locations

Country Name City State
Poland Military Institute of Medicine Warsaw Masovian District

Sponsors (1)

Lead Sponsor Collaborator
Military Institute of Medicine, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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: 10.33 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Venous thromboembolic events. Clinically overt episode of VTE. Follow-up period of 1 year from enrollment.
Other Adverse events of enoxaparin. Episodes of minor and major bleeding or heparin-induced thrombocytopenia. Follow-up period of 1 year from enrollment.
Primary Therapeutic enoxaparin's anti-Xa activity in nephrotic syndrome. Anti-Xa activity values = 0.3 IU/mL in the steady state of enoxaparin concentration, on average between days 3 and 5. Average: Day 3-5
Primary Minimum threshold of enoxaparin's anti-Xa activity. Anti-Xa activity values = 0.2 IU/mL in the steady state of enoxaparin concentration on average between days 3 and 5. Average: Day 3-5
Secondary Severity of nephrotic syndrome. Serum or/and urinary concentration of laboratory markers of disease. Day 0, Day 3-5
Secondary Coagulation system protein. Plasma concentration or activity of secondary hemostasis system protein (clotting factors, fibrinolysis factors, regulatory molecules). Day 0, Day 3-5
Secondary Renal function. Estimated glomerular filtration rate (eGFR) calculated with simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula. Day 0, Day 3-5
Secondary Edema. Clinical evaluation of edema using 3-stages scale (I: <5 kg, II: 5-10 kg, III: >10 kg) at enrollment and on the day of measuring anti-Xa activity of enoxaparin. Day 0, Day 3-5
Secondary Overhydration. Overhydration measured by bioimpedance spectroscopy on the day of measuring anti-Xa activity of enoxaparin. Day 3-5
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