Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome

Aarhus University Hospital, Henrik Birn0 个研究点目标入组 70 人开始时间: 2020年6月9日最近更新: 2021年4月5日

适应症

试验速览

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•To identify abnormalities in the coagulation profile in nephrotic syndrome 50 patients will be included and 50 of these will be treated with dalteparin to describe the effects on the biochemical coagulation profile.
•Age > 18 years and < 80 years
•eGFR > 49 mL/min/1,73 m2
•P-albumin < 20 g/L
•Age > 18-years and < 80-years
•U-albumin excretion > 2.2 g/day
•Known glomerular disease including membranous nephropathy, which may cause nephroticy syndrom or diagnostically unresolved nephrotic syndrome with a planed kidney biopsy.
•To determine the levels of plasma apixaban and its effect on the biochemical coagulation profile in nephrotic syndrome compared to atrial fibrillation patients, 10 of the above patients will be treated with apixaban if they have been diagnosed with membranous nephropathy.
•Patients with atrial fibrillation inclusion criteria:
•Atrial fibrillation
•Age > 18-years and < 80-years
•eGFR > 49 mL/min/1,73 m2
•P-albumin > 36 g/lL
•U-albumin excretion < 300 mg/day
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 35

•Kontraindikation to apixaban.
•Kontraindikation to dalteparin.
•Known allergy or intolerance to apixaban.
•Known allergy or intolerance to dalteparin.
•Treatment with anticoagulation for other reasons.
•Treatment with COX-1 inhibitors or ADP receptor inhibitors.
•Known acquired or congenital coagulation defect not related to nephrotic syndrome or thromboembolic disease within 3 months.
•Known diabetes mellitus.
•Lack of compliance, comorbidity or other conditions that, in the eyes of the inclusive physician, make the patient unfit to participate in the trial.
•Pregnancy.

发起方

Aarhus University Hospital, Henrik Birn