Clinical trial
Assessment of Coagulation Disorders and of Enoxaparin's Anti-Xa Activity, When Used for Thromboprophylaxis, in Severe Nephrotic Syndrome.
Name
5/8952 (443)
Description
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.
Trial arms
Trial start
2015-10-01
Estimated PCD
2018-11-30
Trial end
2018-11-30
Status
Terminated
Phase
Early phase I
Treatment
Enoxaparin
Arms:
Control - fixed dose (C-FD), Nephrotic syndrome - adjusted dose (NS-AD), Nephrotic syndrome - fixed dose (NS-FD)
Size
65
Primary endpoint
Therapeutic enoxaparin's anti-Xa activity in nephrotic syndrome.
Average: Day 3-5
Minimum threshold of enoxaparin's anti-Xa activity.
Average: Day 3-5
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 65, 'type': 'ACTUAL'}}
Updated at
2023-01-30
1 organization
1 product
1 indication
Product
EnoxaparinIndication
nephrotic syndrome