Anti-Xa Activity of Enoxaparin for Prevention of Venous Thromboembolism in Severe Nephrotic Syndrome.

Phase 2/3 Terminated 65 enrolled Military Institute od Medicine National Research Institute

Non-randomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start: 2015-10-01
Primary completion: 2018-11-30
Completion: 2018-11-30

Outcome

Met primary endpoint

Stopped: “The primary objectives were achieved.”

paper the high-VTE-risk threshold more often in NS-AD than in NS-FD group (90 vs. 38%, p < 0.001) PMID 34884411 ↗

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enoxaparin sodium	Other / unclassified	1 mg/kg	Subcutaneous
Subject	Enoxaparin sodium	Other / unclassified	40 mg	Subcutaneous