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.
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 treatment. For administrative reasons, the final biochemical tests are performed on day 4, 5, 6 or 7 described as day 4 in this protocol. * Group A: Up to 50 patients with nephrotic syndrome treated with injection Dalteparin 200 Units/kg subcutaneous once a day for 4 days * Group B: 10 patients with nephrotic syndrome and membranous nephropathy treated with Apixaban 5 mg twice daily for 4 days. * Group C: 10 patients with atrial fibrillation and no kidney disease treated with Apixaban 5 mg twice daily for 4 days. Patients participating in the initial part of the study will be included in det second part (Group A) if they meet the inclusion criteria. If the patient is diagnosed with membranous nephropathy it is possible to be included in the initial part as well as the second part (Group A and B).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Drug: Dalteparin 200 units/kg once a day for 4-7 days.
Drug: Apixaban 5 mg twice a day for 4-7 days.
Aarhus University Hospital
Aarhus, Denmark
Initial Thrombin Generation Assay in nephrotic patients treated with Dalteparin
Thrombin Generation Assay is used to monitor the anticoagulation therapy
Time frame: Predose on Day 1
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
Time frame: Predose day 4
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
Time frame: 4 hours postdose on Day 4
Initial Thrombin Generation Assay in nephrotic patients treated with Apixaban
Thrombin Generation Assay is used to monitor the anticoagulation therapy.
Time frame: Predose on Day 1
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.
Time frame: 24 hours
Steady state Thrombin Generation Assay in nephrotic patients treated with Apixaban.
Thrombin Generation Assay is used to monitor the anticoagulation therapy.
Time frame: Predose day 4
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.
Time frame: Predose on Day 1
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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.
Time frame: 24 hours
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.
Time frame: Predose day 4
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.
Time frame: Predose, 2.5, 8, 24 hours and predose Day 4
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.
Time frame: Baseline and predose Day 4
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.
Time frame: Baseline and predose Day 4
Evaluation of bleeding-events durin the study.
Number of cases with bleeding-events.
Time frame: Predose until 7 days after last dose of apixaban.
Evaluation of thromboembolic complications during the study.
Number of cases with thromboembolic complications
Time frame: Predose until 7 days after last dose of apixaban.
Comparing plasma concentration of Apixaban between group B and C
Comparing plasma-Apixaban in nephrotic patients and patients with atrial fibrillation.
Time frame: Day 4
Comparing urine concentration of Apixaban between group B and C
Comparing urine-Apixaban in nephrotic patients and patients with atrial fibrillation.
Time frame: Day 4