Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome
NCT ID: NCT04850378
Last Updated: 2025-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
57 participants
INTERVENTIONAL
2021-03-25
2024-05-01
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Coagulation profile in Nephrotic syndrome
Investigation of the biochemical coagulation profile in patients with nephrotic syndrome.
No interventions assigned to this group
Nephrotic syndrome
Nephrotic patients without diabetes.
Dalteparin
Drug: Dalteparin 200 units/kg once a day for 4-7 days.
Membranous nephropathy and nephrotic syndrome
Membranous nephropathy and nephrotic syndrome.
Apixaban
Drug: Apixaban 5 mg twice a day for 4-7 days.
Atrial fibrillation
Atrial fibrillation with no kidney disease.
Apixaban
Drug: Apixaban 5 mg twice a day for 4-7 days.
Interventions
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Dalteparin
Drug: Dalteparin 200 units/kg once a day for 4-7 days.
Apixaban
Drug: Apixaban 5 mg twice a day for 4-7 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
* 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
* 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 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
18 Years
79 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Sarah Kelddal, MD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Countries
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Other Identifiers
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Prot-0824-2019
Identifier Type: -
Identifier Source: org_study_id
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