Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Comparing Thrombin Generation Assay between group A and B.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Nephrotic syndrome
Nephrotic patients without diabetes.
干预措施: Dalteparin (Drug)
Membranous nephropathy and nephrotic syndrome
Membranous nephropathy and nephrotic syndrome.
干预措施: Apixaban (Drug)
Atrial fibrillation
Atrial fibrillation with no kidney disease.
干预措施: Apixaban (Drug)
结局指标
主要结局
Comparing Thrombin Generation Assay between group A and B.
时间窗: Baseline and predose Day 4
Comparing Thrombin Generation Assay in nephrotic patients treated with Dalteparin and nephrotic patients treated with Apixaban.
Steady state Thrombin Generation Assay (TGA) in nephrotic patients treated with Dalteparin (Nadir TGA value)
时间窗: Predose day 4
Thrombin Generation Assay is used to monitor the anticoagulation therapy
Initial Thrombin Generation Assay in patients with atrial fibrillation and no kidney disease treated with Apixaban
时间窗: Predose on Day 1
Thrombin Generation Assay is used to monitor the anticoagulation therapy.
Initial Thrombin Generation Assay in nephrotic patients treated with Dalteparin
时间窗: Predose on Day 1
Thrombin Generation Assay is used to monitor the anticoagulation therapy
Steady state Thrombin Generation Assay in patients with atrial fibrillation and no kidney disease treated with Apixaban.
时间窗: Predose day 4
Thrombin Generation Assay is used to monitor the anticoagulation therapy.
Comparing Thrombin Generation Assay between group A and C.
时间窗: Baseline and predose Day 4
Comparing Thrombin Generation Assay in nephrotic patients treated with Dalteparin and patients with atrial fibrillation treated with Apixaban.
Steady state Thrombin Generation Assay in nephrotic patients treated with Apixaban.
时间窗: Predose day 4
Thrombin Generation Assay is used to monitor the anticoagulation therapy.
Initial Thrombin Generation Assay in nephrotic patients treated with Apixaban
时间窗: Predose on Day 1
Thrombin Generation Assay is used to monitor the anticoagulation therapy.
Steady state Thrombin Generation Assay (TGA) in nephrotic patients treated with Dalteparin (4 hours TGA value)
时间窗: 4 hours postdose on Day 4
Thrombin Generation Assay is used to monitor the anticoagulation therapy
Thrombin Generation Assay in nephrotic patients treated with Apixaban over the first 24 hours.
时间窗: 24 hours
Thrombin Generation Assay is used to monitor the anticoagulation therapy with blood samples at 2.5, 8, 24 hours.
Thrombin Generation Assay in patients with atrial fibrillation and no kidney disease treated with Apixaban over the first 24 hours.
时间窗: 24 hours
Thrombin Generation Assay is used to monitor the anticoagulation therapy with blood samples at 2.5, 8, 24 hours.
Comparing Thrombin Generation Assay between group B and C.
时间窗: Predose, 2.5, 8, 24 hours and predose Day 4
Comparing Thrombin Generation Assay in nephrotic patients treated with Apixaban and patients with atrial fibrillation treated with Apixaban.
次要结局
- Comparing urine concentration of Apixaban between group B and C(Day 4)
- Evaluation of bleeding-events durin the study.(Predose until 7 days after last dose of apixaban.)
- Evaluation of thromboembolic complications during the study.(Predose until 7 days after last dose of apixaban.)
- Comparing plasma concentration of Apixaban between group B and C(Day 4)