Causes and prevention of thrombosis developed due to the kidney disease nephrotic syndrome

Phase 1

• Conditions: ephrotic syndrome is defined as severe proteinuria (> 0.5 g / day), edema and hypoalbuminemia. It is conditioned by a defect in the kidney's glomerular filtration barrier, resulting in the loss of a large number of plasma proteins including coagulation factors and consequently a increased risk of thromboembolic complications. The most frequent cause of nephrotic syndrome is the renal disease membranous nephropathy, which is associated with the greatest risk of thromboembolic complications.; MedDRA version: 21.1Level: LLTClassification code 10029167Term: Nephrotic syndrome with lesion of membranous glomerulonephritisSystem Organ Class: 100000004857; MedDRA version: 20.0Level: LLTClassification code 10029165Term: Nephrotic syndrome in diseases classified elsewhereSystem Organ Class: 100000004857; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2019-001212-29-DK
• Lead Sponsor: Aarhus University Hospital, Henrik Birn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-09
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified