Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome (CAPTAIN)

  • STATUS
    Recruiting
  • End date
    Oct 1, 2023
  • participants needed
    80
  • sponsor
    University of Aarhus
Updated on 4 June 2022
heparin
fibrillation
glomerular filtration rate
nephropathy
apixaban
dalteparin
kidney biopsy

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).

Details
Condition Nephrotic Syndrome, Thromboembolic Disease
Treatment dalteparin, Apixaban
Clinical Study IdentifierNCT04850378
SponsorUniversity of Aarhus
Last Modified on4 June 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note