Nephrotic SyndromePhase 2/3ENOX-inNSNCT04558892
Anti-Xa Activity of Enoxaparin for Prevention of Venous Thromboembolism in Severe Nephrotic Syndrome.
A Phase 2/3 study testing Enoxaparin in people with Nephrotic Syndrome, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nephrotic Syndrome
- What is being tested?
- Enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2015to 30 Nov 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Coagulation Disorders and of Enoxaparin's Anti-Xa Activity, When Used for Thromboprophylaxis, in Severe Nephrotic Syndrome.
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.
Read the 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
- Being tested
- Enoxaparin
- Keywords
- Nephrotic syndrome, Enoxaparin, Low molecular weight heparin, Anti-Xa activity, Antifactor Xa, Venous thromboembolism
- Medical subject headings
- Nephrotic Syndrome, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
| Study group | Role | What they receive |
|---|---|---|
| Nephrotic syndrome - fixed dose (NS-FD) | Experimental | Drug: Enoxaparin; Dose: 40 mg; Administration: once daily subcutaneously. Receives: Drug: Enoxaparin |
| Nephrotic syndrome - adjusted dose (NS-AD) | Experimental | Drug: Enoxaparin; Dose: 1 mg/kg of ideal body weight; Administration: once daily subcutaneously. Receives: Drug: Enoxaparin |
| Control - fixed dose (C-FD) | Active comparator | Drug: Enoxaparin; Dose: 40 mg; Administration: once daily subcutaneously. Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Average: Day 3-5
Secondary outcomes (5)
Severity of nephrotic syndrome.
Serum or/and urinary concentration of laboratory markers of disease.
Measured: Day 0, Day 3-5
Coagulation system protein.
Plasma concentration or activity of secondary hemostasis system protein (clotting factors, fibrinolysis factors, regulatory molecules).
Measured: 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.
Measured: 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.
Measured: Day 0, Day 3-5
Overhydration.
Overhydration measured by bioimpedance spectroscopy on the day of measuring anti-Xa activity of enoxaparin.
Measured: Day 3-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Oct 2015
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Why it stopped: The primary objectives were achieved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Matyjek, Military Institute od Medicine National Research Institute
- Investigators
- Anna Matyjek, MD, PhD, Principal investigator, Military Institute of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558892
- Sponsor's protocol ID
- 5/8952 (443)
- Acronym
- ENOX-inNS
- Status last verified
- Sep 2020
- First submitted
- 10 Sep 2020
- Last updated
- 30 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34884411
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Coagulation Disorders and of Enoxaparin's Anti-Xa Activity, When Used for Thromboprophylaxis, in Severe Nephrotic Syndrome.
- ClinicalTrials.gov ID
- NCT04558892
- Acronym / sponsor ID
- ENOX-inNS / 5/8952 (443)
- Conditions
- Nephrotic Syndrome
- Keywords
- Nephrotic syndrome, Enoxaparin, Low molecular weight heparin, Anti-Xa activity, Antifactor Xa, Venous thromboembolism
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The primary objectives were achieved.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nephrotic syndrome - fixed dose (NS-FD) | Experimental | Drug: EnoxaparinDrug: Enoxaparin; Dose: 40 mg; Administration: once daily subcutaneously. |
| Nephrotic syndrome - adjusted dose (NS-AD) | Experimental | Drug: EnoxaparinDrug: Enoxaparin; Dose: 1 mg/kg of ideal body weight; Administration: once daily subcutaneously. |
| Control - fixed dose (C-FD) | Active comparator | Drug: EnoxaparinDrug: Enoxaparin; Dose: 40 mg; Administration: once daily subcutaneously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoxaparin | Drug | Control - fixed dose (C-FD), Nephrotic syndrome - adjusted dose (NS-AD), Nephrotic syndrome - fixed dose (NS-FD) |
Primary outcome
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.
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.
5 secondary outcomes
Severity of nephrotic syndrome.
Time frame: Day 0, Day 3-5
Coagulation system protein.
Time frame: Day 0, Day 3-5
Renal function.
Time frame: Day 0, Day 3-5
Edema.
Time frame: Day 0, Day 3-5
Overhydration.
Time frame: Day 3-5
Results and safety
The study was stopped early (reason given: The primary objectives were achieved.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Results publication: PubMed 34884411Matyjek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Matyjek, MD, PhD principal investigator
Military Institute of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Enoxaparin in people with Nephrotic Syndrome, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The primary objectives were achieved.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic enoxaparin's anti-Xa activity in nephrotic syndrome. (time frame: Average: Day 3-5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04558892, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.