Nephrotic Syndrome Clinical Trial
— CAPTAINOfficial title:
Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | October 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Initial Thrombin Generation Assay in nephrotic patients treated with Dalteparin | Thrombin Generation Assay is used to monitor the anticoagulation therapy | Predose on Day 1 | |
Primary | Steady state Thrombin Generation Assay (TGA) in nephrotic patients treated with Dalteparin (Nadir TGA value) | Thrombin Generation Assay is used to monitor the anticoagulation therapy | Predose day 4 | |
Primary | Steady state Thrombin Generation Assay (TGA) in nephrotic patients treated with Dalteparin (4 hours TGA value) | Thrombin Generation Assay is used to monitor the anticoagulation therapy | 4 hours postdose on Day 4 | |
Primary | Initial Thrombin Generation Assay in nephrotic patients treated with Apixaban | Thrombin Generation Assay is used to monitor the anticoagulation therapy. | Predose on Day 1 | |
Primary | Thrombin Generation Assay in nephrotic patients treated with Apixaban over the first 24 hours. | Thrombin Generation Assay is used to monitor the anticoagulation therapy with blood samples at 2.5, 8, 24 hours. | 24 hours | |
Primary | Steady state Thrombin Generation Assay in nephrotic patients treated with Apixaban. | Thrombin Generation Assay is used to monitor the anticoagulation therapy. | Predose day 4 | |
Primary | Initial Thrombin Generation Assay in patients with atrial fibrillation and no kidney disease treated with Apixaban | Thrombin Generation Assay is used to monitor the anticoagulation therapy. | Predose on Day 1 | |
Primary | Thrombin Generation Assay in patients with atrial fibrillation and no kidney disease treated with Apixaban over the first 24 hours. | Thrombin Generation Assay is used to monitor the anticoagulation therapy with blood samples at 2.5, 8, 24 hours. | 24 hours | |
Primary | Steady state Thrombin Generation Assay in patients with atrial fibrillation and no kidney disease treated with Apixaban. | Thrombin Generation Assay is used to monitor the anticoagulation therapy. | Predose day 4 | |
Primary | Comparing Thrombin Generation Assay between group B and C. | Comparing Thrombin Generation Assay in nephrotic patients treated with Apixaban and patients with atrial fibrillation treated with Apixaban. | Predose, 2.5, 8, 24 hours and predose Day 4 | |
Primary | Comparing Thrombin Generation Assay between group A and C. | Comparing Thrombin Generation Assay in nephrotic patients treated with Dalteparin and patients with atrial fibrillation treated with Apixaban. | Baseline and predose Day 4 | |
Primary | Comparing Thrombin Generation Assay between group A and B. | Comparing Thrombin Generation Assay in nephrotic patients treated with Dalteparin and nephrotic patients treated with Apixaban. | Baseline and predose Day 4 | |
Secondary | Evaluation of bleeding-events durin the study. | Number of cases with bleeding-events. | Predose until 7 days after last dose of apixaban. | |
Secondary | Evaluation of thromboembolic complications during the study. | Number of cases with thromboembolic complications | Predose until 7 days after last dose of apixaban. | |
Secondary | Comparing plasma concentration of Apixaban between group B and C | Comparing plasma-Apixaban in nephrotic patients and patients with atrial fibrillation. | Day 4 | |
Secondary | Comparing urine concentration of Apixaban between group B and C | Comparing urine-Apixaban in nephrotic patients and patients with atrial fibrillation. | Day 4 |
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