Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome

Launched by UNIVERSITY OF AARHUS · Apr 14, 2021

Keywords

ClinConnect Summary

The initial part of the study is a prospective cross-sectional study which will describe the biochemical coagulation profile in nephrotic patients. It will include 60 patients with nephrotic syndrome and data from 50 anonymous blood donors matched in age and gender for comparison.

The second part of the study is an open-label, controlled, non-randomized, interventional clinical trial consisting of 3 groups of patients with nephrotic syndrome or atrial fibrillation treated with either Dalteparin or Apixaban. The study participant is expected to be in stable condition after 4 full days of tr...

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Eligibility criteria

• • Inclusion Criteria: Nephrotic patients - no intervention
• • Age 18-79 years
• • Estimated Glomerular Filtration Rate (eGFR) \> 49 mL/min/1.73 m2
• • P-albumin \< 30 g/L
• • U-Albumin excretion \> 2.2 g/day
• • Known glomerular disease including membranous nephropathy, which may cause nephrotic syndrome or diagnostically unresolved nephrotic syndrome with a planed kidney biopsy.
• • Inclusion Criteria: Nephrotic patients treated with Dalteparin
• • Age 18-79 years
• • eGFR \> 49 mL/min/1.73 m2
• • P-albumin \< 25 g/L
• • U-Albumin excretion \> 2.2 g/day
• • Known glomerular disease including membranous nephropathy, which may cause nephrotic syndrome or diagnostically unresolved nephrotic syndrome with a planed kidney biopsy.
• • Inclusion Criteria: Nephrotic patients treated with Apixaban
• • Age 18-79 years
• • eGFR \> 49 mL/min/1.73 m2
• • P-albumin \< 25 g/L
• • U-Albumin excretion \> 2.2 g/day
• • Membranous Nephropathy
• • Inclusion Criteria: Patients with atrial fibrillation treated with Apixaban
• • Age 18-79 years
• • eGFR \> 49 mL/min/1.73 m2
• • P-albumin \> 36 g/L
• • U-Albumin excretion \< 300 mg/day
• • Atrial Fibrillation
• Exclusion Criteria:
• • Contraindication to Apixaban
• • Contraindication to Dalteparin
• • Known allergy or intolerance to Apixaban
• • Known allergy or intolerance to Dalteparin
• • Treatment with anticoagulation for other reasons.
• • Treatment with cyclooxygenase-1-inhibitors or Adenosine Diphosphate (ADP) receptor inhibitors.
• • Known acquired or congenital coagulation defect non related to nephrotic syndrome or thromboembolic disease within 3 months.
• • Known diabetes mellitus.
• • Lack of compliance, comorbidity or other conditions that, in the patients unfit to participate in the trial.
• • Pregnancy