Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04558892
Recruitment Status : Terminated (The primary objectives were achieved.)
First Posted : September 22, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Anna Matyjek, Military Institute of Medicine, Poland

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.

Condition or disease Intervention/treatment Phase
Nephrotic Syndrome Drug: Enoxaparin Phase 2 Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assessment of Coagulation Disorders and of Enoxaparin's Anti-Xa Activity, When Used for Thromboprophylaxis, in Severe Nephrotic Syndrome.
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nephrotic syndrome - fixed dose (NS-FD)
Drug: Enoxaparin; Dose: 40 mg; Administration: once daily subcutaneously.
Drug: Enoxaparin
Experimental: Nephrotic syndrome - adjusted dose (NS-AD)
Drug: Enoxaparin; Dose: 1 mg/kg of ideal body weight; Administration: once daily subcutaneously.
Drug: Enoxaparin
Active Comparator: Control - fixed dose (C-FD)
Drug: Enoxaparin; Dose: 40 mg; Administration: once daily subcutaneously.
Drug: Enoxaparin



Primary Outcome Measures :
  1. Therapeutic enoxaparin's anti-Xa activity in nephrotic syndrome. [ Time Frame: Average: Day 3-5 ]
    Anti-Xa activity values ≥ 0.3 IU/mL in the steady state of enoxaparin concentration, on average between days 3 and 5.

  2. Minimum threshold of enoxaparin's anti-Xa activity. [ Time Frame: Average: Day 3-5 ]
    Anti-Xa activity values ≥ 0.2 IU/mL in the steady state of enoxaparin concentration on average between days 3 and 5.


Secondary Outcome Measures :
  1. Severity of nephrotic syndrome. [ Time Frame: Day 0, Day 3-5 ]
    Serum or/and urinary concentration of laboratory markers of disease.

  2. Coagulation system protein. [ Time Frame: Day 0, Day 3-5 ]
    Plasma concentration or activity of secondary hemostasis system protein (clotting factors, fibrinolysis factors, regulatory molecules).

  3. Renal function. [ Time Frame: Day 0, Day 3-5 ]
    Estimated glomerular filtration rate (eGFR) calculated with simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula.

  4. Edema. [ Time Frame: Day 0, Day 3-5 ]
    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.

  5. Overhydration. [ Time Frame: Day 3-5 ]
    Overhydration measured by bioimpedance spectroscopy on the day of measuring anti-Xa activity of enoxaparin.


Other Outcome Measures:
  1. Venous thromboembolic events. [ Time Frame: Follow-up period of 1 year from enrollment. ]
    Clinically overt episode of VTE.

  2. Adverse events of enoxaparin. [ Time Frame: Follow-up period of 1 year from enrollment. ]
    Episodes of minor and major bleeding or heparin-induced thrombocytopenia.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04558892


Locations
Layout table for location information
Poland
Military Institute of Medicine
Warsaw, Masovian District, Poland, 04-141
Sponsors and Collaborators
Military Institute of Medicine, Poland
Investigators
Layout table for investigator information
Principal Investigator: Anna Matyjek, MD, PhD Military Institute of Medicine
Layout table for additonal information
Responsible Party: Anna Matyjek, Principal Investigator, Military Institute of Medicine, Poland
ClinicalTrials.gov Identifier: NCT04558892    
Other Study ID Numbers: 5/8952 (443)
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Matyjek, Military Institute of Medicine, Poland:
Nephrotic syndrome
Enoxaparin
Low molecular weight heparin
Anti-Xa activity
Antifactor Xa
Venous thromboembolism
Additional relevant MeSH terms:
Layout table for MeSH terms
Nephrotic Syndrome
Nephrosis
Thromboembolism
Venous Thromboembolism
Syndrome
Disease
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action