A Phase 2/3 interventional study of Enoxaparin in Nephrotic Syndrome, sponsored by Military Institute od Medicine National Research Institute. Terminated at 1 site in Poland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-30.
Sponsored by Military Institute od Medicine National Research Institute · Phase 2/3, Interventional, and Prevention
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.
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.
Exclusion Criteria:
Drug: Enoxaparin; Dose: 40 mg; Administration: once daily subcutaneously.
Drug: Enoxaparin
Drug: Enoxaparin; Dose: 1 mg/kg of ideal body weight; Administration: once daily subcutaneously.
Drug: Enoxaparin
Drug: Enoxaparin; Dose: 40 mg; Administration: once daily subcutaneously.
Drug: Enoxaparin
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.
Time frame: Average: Day 3-5
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.
Time frame: Average: Day 3-5
Severity of nephrotic syndrome.
Serum or/and urinary concentration of laboratory markers of disease.
Time frame: Day 0, Day 3-5
Coagulation system protein.
Plasma concentration or activity of secondary hemostasis system protein (clotting factors, fibrinolysis factors, regulatory molecules).
Time frame: Day 0, Day 3-5
Renal function.
Estimated glomerular filtration rate (eGFR) calculated with simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula.
Time frame: Day 0, Day 3-5
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.
Time frame: Day 0, Day 3-5
Overhydration.
Overhydration measured by bioimpedance spectroscopy on the day of measuring anti-Xa activity of enoxaparin.
Time frame: Day 3-5
Venous thromboembolic events.
Clinically overt episode of VTE.
Time frame: Follow-up period of 1 year from enrollment.
Adverse events of enoxaparin.
Episodes of minor and major bleeding or heparin-induced thrombocytopenia.
Time frame: Follow-up period of 1 year from enrollment.
This study is terminated, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Military Institute od Medicine National Research Institute