Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The study aims to describe the biochemical coagulation profile and investigate the effect of Low molecular weight heparin and Apixaban on this profile in patients with nephrotic syndrome.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Treatments: Apixaban; Dalteparin; Heparin, Low-Molecular-Weight; Tinzaparin

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