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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04850378
Other study ID # Prot-0824-2019
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 25, 2021
Est. completion date October 1, 2023

Study information

Verified date May 2022
Source University of Aarhus
Contact Sarah Kelddal, MD
Phone +45 4046 0803
Email sarah.kelddal@midt.rm.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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).


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
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.

Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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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