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Nephrotic SyndromePhase 1/2CAPTAINNCT04850378

Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome

A Phase 1/2 study testing Dalteparin and Apixaban in people with Nephrotic Syndrome and Thromboembolic Disease, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Nephrotic Syndrome, Thromboembolic Disease
What is being tested?
Dalteparin and Apixaban
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteDenmark
Study dates
25 Mar 2021to 1 May 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Aarhus University Hospital

    Aarhus, 8200

Other trials in Denmark

About this study

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.

Read the 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).

Being tested
Dalteparin, Apixaban
Keywords
Nephrotic Syndrome, Glomerulonephritis, Hypoalbuminemia, Proteinuria, Thromboembolic Disease, Membranous Nephropathy
Medical subject headings
Nephrotic Syndrome, Thromboembolism, Glomerulonephritis, Hypoalbuminemia, Proteinuria, Glomerulonephritis, Membranous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DalteparinDrug

    Also called Fragmin

    Drug: Dalteparin 200 units/kg once a day for 4-7 days.

  • ApixabanDrug

    Also called Eliquis

    Drug: Apixaban 5 mg twice a day for 4-7 days.

Study groups in NCT04850378
Study groupRoleWhat they receive
Coagulation profile in Nephrotic syndromeNo interventionInvestigation of the biochemical coagulation profile in patients with nephrotic syndrome.
Nephrotic syndromeExperimentalNephrotic patients without diabetes.
Receives: Drug: Dalteparin
Membranous nephropathy and nephrotic syndromeExperimentalMembranous nephropathy and nephrotic syndrome.
Receives: Drug: Apixaban
Atrial fibrillationActive comparatorAtrial fibrillation with no kidney disease.
Receives: Drug: Apixaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Initial Thrombin Generation Assay in nephrotic patients treated with Dalteparin

    Thrombin Generation Assay is used to monitor the anticoagulation therapy

    Measured: Predose on Day 1

  2. 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

    Measured: Predose day 4

  3. 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

    Measured: 4 hours postdose on Day 4

  4. Initial Thrombin Generation Assay in nephrotic patients treated with Apixaban

    Thrombin Generation Assay is used to monitor the anticoagulation therapy.

    Measured: Predose on Day 1

  5. 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.

    Measured: 24 hours

  6. Steady state Thrombin Generation Assay in nephrotic patients treated with Apixaban.

    Thrombin Generation Assay is used to monitor the anticoagulation therapy.

    Measured: Predose day 4

  7. 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.

    Measured: Predose on Day 1

  8. 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.

    Measured: 24 hours

  9. 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.

    Measured: Predose day 4

  10. 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.

    Measured: Predose, 2.5, 8, 24 hours and predose Day 4

  11. 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.

    Measured: Baseline and predose Day 4

  12. 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.

    Measured: Baseline and predose Day 4

Secondary outcomes (4)

  1. Evaluation of bleeding-events durin the study.

    Number of cases with bleeding-events.

    Measured: Predose until 7 days after last dose of apixaban.

  2. Evaluation of thromboembolic complications during the study.

    Number of cases with thromboembolic complications

    Measured: Predose until 7 days after last dose of apixaban.

  3. Comparing plasma concentration of Apixaban between group B and C

    Comparing plasma-Apixaban in nephrotic patients and patients with atrial fibrillation.

    Measured: Day 4

  4. Comparing urine concentration of Apixaban between group B and C

    Comparing urine-Apixaban in nephrotic patients and patients with atrial fibrillation.

    Measured: Day 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2021
  2. Study start25 Mar 2021
  3. Primary completion1 May 2024
  4. Study completion1 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
An open-label, controlled, non-randomized, interventional clinical trial.
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04850378
Sponsor's protocol ID
Prot-0824-2019
Acronym
CAPTAIN
Status last verified
May 2024
First submitted
9 Apr 2021
Last updated
11 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kelddal S, Grove EL, Duus CL, Nygaard LB, Kristensen T, Mose FH, Gregersen JW, Hvas AM, Birn H. Apixaban Concentrations and Effects on Coagulation in Patients With Nephrotic Syndrome. Kidney Med. 2025 Oct 10;7(12):101136. doi: 10.1016/j.xkme.2025.101136. eCollection 2025 Dec.

    PubMed 41333097

  • Kelddal S, Grove EL, Duus CL, Nygaard LB, Kristensen T, Mose FH, Gregersen JW, Hvas AM, Birn H. Alterations in Coagulation and Endothelial Function in Nephrotic Syndrome: A Multicenter, Cross-Sectional Analysis. Kidney360. 2025 Nov 1;6(11):1960-1969. doi: 10.34067/KID.0000000865. Epub 2025 Jun 6.

    PubMed 40478760

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dalteparin and Apixaban in people with Nephrotic Syndrome and Thromboembolic Disease, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Initial Thrombin Generation Assay in nephrotic patients treated with Dalteparin (time frame: Predose on Day 1). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04850378, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.

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