A Phase 1/2 interventional study of Dalteparin and Apixaban in Nephrotic Syndrome and Thromboembolic Disease, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-04-11.
Sponsored by University of Aarhus · Phase 1/2, Interventional, and Treatment
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.
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.
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).
191 studies on the registry are indexed under Nephrotic Syndrome; 65 are open to participants now.
This study's enrollment of 57 is above the median of 46 across 122 interventional studies indexed under Nephrotic Syndrome.
Browse Nephrotic Syndrome studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Nephrotic patients - no intervention
Inclusion Criteria: Nephrotic patients treated with Dalteparin
Inclusion Criteria: Nephrotic patients treated with Apixaban
Inclusion Criteria: Patients with atrial fibrillation treated with Apixaban
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigation of the biochemical coagulation profile in patients with nephrotic syndrome.
Nephrotic patients without diabetes.
Drug: Dalteparin
Membranous nephropathy and nephrotic syndrome.
Drug: Apixaban
Atrial fibrillation with no kidney disease.
Drug: Apixaban
Drug: Dalteparin 200 units/kg once a day for 4-7 days.
Also known as: Fragmin
Drug: Apixaban 5 mg twice a day for 4-7 days.
Also known as: Eliquis
Initial Thrombin Generation Assay in nephrotic patients treated with Dalteparin
Thrombin Generation Assay is used to monitor the anticoagulation therapy
Time frame: Predose on Day 1
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
Time frame: Predose day 4
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
Time frame: 4 hours postdose on Day 4
Initial Thrombin Generation Assay in nephrotic patients treated with Apixaban
Thrombin Generation Assay is used to monitor the anticoagulation therapy.
Time frame: Predose on Day 1
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.
Time frame: 24 hours
Steady state Thrombin Generation Assay in nephrotic patients treated with Apixaban.
Thrombin Generation Assay is used to monitor the anticoagulation therapy.
Time frame: Predose day 4
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.
Time frame: Predose on Day 1
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.
Time frame: 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.
Time frame: Predose day 4
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.
Time frame: Predose, 2.5, 8, 24 hours and predose Day 4
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.
Time frame: Baseline and predose Day 4
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.
Time frame: Baseline and predose Day 4
Evaluation of bleeding-events durin the study.
Number of cases with bleeding-events.
Time frame: Predose until 7 days after last dose of apixaban.
Evaluation of thromboembolic complications during the study.
Number of cases with thromboembolic complications
Time frame: Predose until 7 days after last dose of apixaban.
Comparing plasma concentration of Apixaban between group B and C
Comparing plasma-Apixaban in nephrotic patients and patients with atrial fibrillation.
Time frame: Day 4
Comparing urine concentration of Apixaban between group B and C
Comparing urine-Apixaban in nephrotic patients and patients with atrial fibrillation.
Time frame: Day 4
Plan to share: No
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Studies of the drugs tested here: Dalteparin · Apixaban