Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome (NCT04850378) | Clinical Trial Compass
CompletedPhase 1/2
Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome
Denmark57 participantsStarted 2021-03-25
Plain-language 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.
Who can participate
Age range
18 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 nep…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Initial Thrombin Generation Assay in nephrotic patients treated with Dalteparin
Timeframe: Predose on Day 1
2
Steady state Thrombin Generation Assay (TGA) in nephrotic patients treated with Dalteparin (Nadir TGA value)
Timeframe: Predose day 4
3
Steady state Thrombin Generation Assay (TGA) in nephrotic patients treated with Dalteparin (4 hours TGA value)
Timeframe: 4 hours postdose on Day 4
4
Initial Thrombin Generation Assay in nephrotic patients treated with Apixaban
Timeframe: Predose on Day 1
5
Thrombin Generation Assay in nephrotic patients treated with Apixaban over the first 24 hours.
Timeframe: 24 hours
6
Steady state Thrombin Generation Assay in nephrotic patients treated with Apixaban.
Timeframe: Predose day 4
7
Initial Thrombin Generation Assay in patients with atrial fibrillation and no kidney disease treated with Apixaban