Back to resultsCauses and Prevention of Thromboembolic Disease in Nephrotic Syndrome (CAPTAIN)
Primary Purpose
Nephrotic Syndrome, Thromboembolic Disease
Status
Recruiting
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Dalteparin
Apixaban
Sponsored by
About this trial
This is an interventional treatment trial for Nephrotic Syndrome focused on measuring Nephrotic Syndrome, Glomerulonephritis, Hypoalbuminemia, Proteinuria, Thromboembolic Disease, Membranous Nephropathy
Eligibility Criteria
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
Sites / Locations
- Aarhus University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Active Comparator
Arm Label
Coagulation profile in Nephrotic syndrome
Nephrotic syndrome
Membranous nephropathy and nephrotic syndrome
Atrial fibrillation
Arm Description
Investigation of the biochemical coagulation profile in patients with nephrotic syndrome.
Nephrotic patients without diabetes.
Membranous nephropathy and nephrotic syndrome.
Atrial fibrillation with no kidney disease.
Outcomes
Primary Outcome Measures
Initial Thrombin Generation Assay in nephrotic patients treated with Dalteparin
Thrombin Generation Assay is used to monitor the anticoagulation therapy
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
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
Initial Thrombin Generation Assay in nephrotic patients treated with Apixaban
Thrombin Generation Assay is used to monitor the anticoagulation therapy.
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.
Steady state Thrombin Generation Assay in nephrotic patients treated with Apixaban.
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
Thrombin Generation Assay is used to monitor the anticoagulation therapy.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Evaluation of bleeding-events durin the study.
Number of cases with bleeding-events.
Evaluation of thromboembolic complications during the study.
Number of cases with thromboembolic complications
Comparing plasma concentration of Apixaban between group B and C
Comparing plasma-Apixaban in nephrotic patients and patients with atrial fibrillation.
Comparing urine concentration of Apixaban between group B and C
Comparing urine-Apixaban in nephrotic patients and patients with atrial fibrillation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04850378
Brief Title
Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome
Acronym
CAPTAIN
Official Title
Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrotic Syndrome, Thromboembolic Disease
Keywords
Nephrotic Syndrome, Glomerulonephritis, Hypoalbuminemia, Proteinuria, Thromboembolic Disease, Membranous Nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
An open-label, controlled, non-randomized, interventional clinical trial.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Coagulation profile in Nephrotic syndrome
Arm Type
No Intervention
Arm Description
Investigation of the biochemical coagulation profile in patients with nephrotic syndrome.
Arm Title
Nephrotic syndrome
Arm Type
Experimental
Arm Description
Nephrotic patients without diabetes.
Arm Title
Membranous nephropathy and nephrotic syndrome
Arm Type
Experimental
Arm Description
Membranous nephropathy and nephrotic syndrome.
Arm Title
Atrial fibrillation
Arm Type
Active Comparator
Arm Description
Atrial fibrillation with no kidney disease.
Intervention Type
Drug
Intervention Name(s)
Dalteparin
Other Intervention Name(s)
Fragmin
Intervention Description
Drug: Dalteparin 200 units/kg once a day for 4-7 days.
Intervention Type
Drug
Intervention Name(s)
Apixaban
Other Intervention Name(s)
Eliquis
Intervention Description
Drug: Apixaban 5 mg twice a day for 4-7 days.
Primary Outcome Measure Information:
Title
Initial Thrombin Generation Assay in nephrotic patients treated with Dalteparin
Description
Thrombin Generation Assay is used to monitor the anticoagulation therapy
Time Frame
Predose on Day 1
Title
Steady state Thrombin Generation Assay (TGA) in nephrotic patients treated with Dalteparin (Nadir TGA value)
Description
Thrombin Generation Assay is used to monitor the anticoagulation therapy
Time Frame
Predose day 4
Title
Steady state Thrombin Generation Assay (TGA) in nephrotic patients treated with Dalteparin (4 hours TGA value)
Description
Thrombin Generation Assay is used to monitor the anticoagulation therapy
Time Frame
4 hours postdose on Day 4
Title
Initial Thrombin Generation Assay in nephrotic patients treated with Apixaban
Description
Thrombin Generation Assay is used to monitor the anticoagulation therapy.
Time Frame
Predose on Day 1
Title
Thrombin Generation Assay in nephrotic patients treated with Apixaban over the first 24 hours.
Description
Thrombin Generation Assay is used to monitor the anticoagulation therapy with blood samples at 2.5, 8, 24 hours.
Time Frame
24 hours
Title
Steady state Thrombin Generation Assay in nephrotic patients treated with Apixaban.
Description
Thrombin Generation Assay is used to monitor the anticoagulation therapy.
Time Frame
Predose day 4
Title
Initial Thrombin Generation Assay in patients with atrial fibrillation and no kidney disease treated with Apixaban
Description
Thrombin Generation Assay is used to monitor the anticoagulation therapy.
Time Frame
Predose on Day 1
Title
Thrombin Generation Assay in patients with atrial fibrillation and no kidney disease treated with Apixaban over the first 24 hours.
Description
Thrombin Generation Assay is used to monitor the anticoagulation therapy with blood samples at 2.5, 8, 24 hours.
Time Frame
24 hours
Title
Steady state Thrombin Generation Assay in patients with atrial fibrillation and no kidney disease treated with Apixaban.
Description
Thrombin Generation Assay is used to monitor the anticoagulation therapy.
Time Frame
Predose day 4
Title
Comparing Thrombin Generation Assay between group B and C.
Description
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
Title
Comparing Thrombin Generation Assay between group A and C.
Description
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
Title
Comparing Thrombin Generation Assay between group A and B.
Description
Comparing Thrombin Generation Assay in nephrotic patients treated with Dalteparin and nephrotic patients treated with Apixaban.
Time Frame
Baseline and predose Day 4
Secondary Outcome Measure Information:
Title
Evaluation of bleeding-events durin the study.
Description
Number of cases with bleeding-events.
Time Frame
Predose until 7 days after last dose of apixaban.
Title
Evaluation of thromboembolic complications during the study.
Description
Number of cases with thromboembolic complications
Time Frame
Predose until 7 days after last dose of apixaban.
Title
Comparing plasma concentration of Apixaban between group B and C
Description
Comparing plasma-Apixaban in nephrotic patients and patients with atrial fibrillation.
Time Frame
Day 4
Title
Comparing urine concentration of Apixaban between group B and C
Description
Comparing urine-Apixaban in nephrotic patients and patients with atrial fibrillation.
Time Frame
Day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Kelddal, MD
Phone
+45 4046 0803
Email
sarah.kelddal@midt.rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Henrik Birn, Professor
Phone
+45 4046 0271
Email
hb@biomed.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Kelddal, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Kelddal, MD
Phone
+45 4046 0803
Email
sarah.kelddal@midt.rm.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome
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