Status:
COMPLETED
Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome
Lead Sponsor:
University of Aarhus
Conditions:
Nephrotic Syndrome
Thromboembolic Disease
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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.
- 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
- 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
- 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
Key Trial Info
Start Date :
March 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04850378
Start Date
March 25 2021
End Date
May 1 2024
Last Update
April 11 2025
Active Locations (1)
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1
Aarhus University Hospital
Aarhus, Denmark, 8200