A Phase 1 interventional study of Apixaban 5 MG in Nephrotic Syndrome and Membranous Nephropathy, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by University of North Carolina, Chapel Hill · Phase 1, Interventional, and Treatment
This phase I study is a single arm, multi-dose study that will evaluate steady-state apixaban pharmacokinetics (PK) and pharmacodynamics (PD) in subjects with Nephrotic Syndrome (NS) vs healthy control subjects. This study will enroll 20 subjects diagnosed with NS and 10 healthy control subjects. Comparing differences in steady-state apixaban PK/PD parameters between subjects with NS and healthy volunteers will be essential to identifying a safe and effective apixaban dose and dose administration schedule for future randomized controlled trials (RCTs).
191 studies on the registry are indexed under Nephrotic Syndrome; 65 are open to participants now.
This study's enrollment of 22 is below the median of 46 across 122 interventional studies indexed under Nephrotic Syndrome.
Browse Nephrotic Syndrome studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Study Subjects
Control Subjects
Exclusion Criteria:
Baseline prolonged , defined as INR >1.4
Use of any prescription medications, over-the-counter (OTC) medications, or herbal products that are strong inhibitors or inducers of and/or P-gp within 14 days prior to Study Day 1 or anticipated need for such drugs during the study. Examples included:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients diagnosed with Nephrotic syndrome will be in this arm.
Drug: Apixaban 5 MG
Healthy volunteers will be in this arm.
Drug: Apixaban 5 MG
1 - 5 mg tablet taken orally twice a day
Also known as: Eliquis
Steady-state Area Under the Plasma Concentration Versus Time Curve From Time Zero to 12 Hours of Apixaban
Area Under the Curve (AUC (0-12)) is the area under the curve from time 0 to 12 hour after apixaban steady state concentration is reached.
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose approximately on Day 8
Initial Dose Area Under the Plasma Concentration Versus Time Curve From Time Zero to 12 Hours of Apixaban
AUC (0-12) is the area under the curve from time 0 to 12 hour after the initial dose
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose
Steady state Elimination of Half-Life of Apixaban
Mean terminal phase plasma t½ of apixaban at steady-state
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose approximately on Day 8
Initial dose Elimination of Half-Life of Apixaban
Mean terminal phase plasma t½ of apixaban after initial dose
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose
Steady-state Maximum Observed Plasma Concentration of Apixaban
Maximum observed drug concentration in plasma after administration (Cmax) of apixaban at steady-state
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose approximately on Day 8
Initial dose Maximum Observed Plasma Concentration of Apixaban
Maximum observed drug concentration in plasma after administration (Cmax) of apixaban after initial dose
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose
Steady state Plasma Clearance as a Function of Bioavailability of Apixaban
CL/F of apixaban of apixaban at steady-state
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose approximately on Day 8
Initial dose Plasma Clearance (CL) as a Function of Bioavailability (F) of Apixaban
CL/F of apixaban of apixaban after initial dose
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose
Initial Thrombin Generation Assay (TGA)
Initial apixaban TGA concentrations. Thrombin generation assay is used to investigate hypo- or hypercoagulability.
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose
Steady state Thrombin Generation Assay (TGA)
Steady state apixaban TGA concentrations. Thrombin generation assay is used to investigate hypo- or hypercoagulability.
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose approximately on Day 8
Initial dose Anti-Xa activity
Initial apixaban dose Anti-Xa activity. Anti-Xa activity will be used to measure plasma apixaban levels.
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose
Steady state Anti-Xa activity
Steady state apixaban dose Anti-Xa activity. Anti-Xa activity will be used to measure plasma apixaban levels.
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose approximately on Day 8
Initial dose Activated Partial Thromboplastin Time (aPTT)
Initial apixaban dose aPTT. The activated partial thromboplastin time (aPTT) will be used to characterize the coagulation of the blood.
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose
Steady state Activated Partial Thromboplastin Time (aPTT)
Steady state apixaban dose aPTT. The activated partial thromboplastin time (aPTT) will be used to characterize the coagulation of the blood.
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose approximately on Day 8
Initial dose International Normalised Ratio (INR)
Initial apixaban dose INR. INR is defined as the ratio of the participants prothrombin time and the normal mean prothrombin time. The INR will help determine the risk of coagulation.
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose
Steady state International Normalised Ratio (INR)
Steady state apixaban dose INR. INR is defined as the ratio of the participants prothrombin time and the normal mean prothrombin time. The INR will help determine the risk of coagulation.
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose approximately on Day 8
Initial dose Prothrombin time (PT)
Initial apixaban dose PT. Prothrombin is defined as time taken by the blood to clot in the participants.
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose
Steady state Prothrombin time (PT)
Steady state apixaban dose PT. Prothrombin is defined as time taken by the blood to clot in the participants.
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose approximately on Day 8
Total Adverse Events (AE)
Number of subjects experiencing AEs, bleeding-related AEs, serious adverse events (SAEs), or discontinuations due to AEs
Time frame: From screening to Day 10 after initial study drug administration
Pharmacogenetics and AUC0-12
Associations between germline variants within genes that encode proteins that are central to apixaban metabolism and transport and AUC0-12
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose approximately on Day 1 & 8
Pharmacogenetics and CL/F
Associations between germline variants within genes that encode proteins that are central to apixaban metabolism and transport and CL/F
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose approximately on Day 1 & 8
Pharmacogenetics and t1/2
Associations between germline variants within genes that encode proteins that are central to apixaban metabolism and transport and t1/2
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose approximately on Day 1 & 8
Pharmacogenetics and anti-Xa
Associations between germline variants within genes that encode proteins that are central to apixaban metabolism and transport and anti-Xa
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose approximately on Day 1 & 8
Pharmacogenetics and thrombin generation
Associations between germline variants within genes that encode proteins that are central to apixaban metabolism and transport and thrombin generation
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose approximately on Day 1 & 8
Pharmacogenetics and Cmax
Associations between germline variants within genes that encode proteins that are central to apixaban metabolism and transport and Cmax
Time frame: Predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose approximately on Day 1 & 8
Baseline Quantitative D-Dimer
Quantitative D-Dimer levels at baseline before first dose of apixaban
Time frame: Baseline at hour 0
Quantitative D-Dimer at steady-state
Quantitative D-Dimer levels at steady-state apixaban
Time frame: Day 8 at hour 8
Plan to share: No
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Studies of the drug tested here: Apixaban
University of North Carolina, Chapel Hill →