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Anticoagulant

Apixaban 5 MG for Nephrotic Syndrome

Phase 1
Waitlist Available
Led By Daniel Crona, PharmD, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose approximately on day 1 & 8
Awards & highlights

Study Summary

This trial will compare how well the blood thinner apixaban works in people with nephrotic syndrome vs. healthy people. 20 people with nephrotic syndrome and 10 healthy people will be enrolled.

Eligible Conditions
  • Nephrotic Syndrome
  • Membranous Glomerulonephritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose approximately on day 1 & 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose; 1, 2, 3, 4, 6, and 8 hours (hr) postdose approximately on day 1 & 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Steady-state Area Under the Plasma Concentration Versus Time Curve From Time Zero to 12 Hours of Apixaban
Secondary outcome measures
Initial Dose Area Under the Plasma Concentration Versus Time Curve From Time Zero to 12 Hours of Apixaban
Initial Thrombin Generation Assay (TGA)
Initial dose Activated Partial Thromboplastin Time (aPTT)
+15 more
Other outcome measures
Baseline Quantitative D-Dimer
Pharmacogenetics and AUC0-12
Pharmacogenetics and CL/F
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Nephrotic Syndrome ArmExperimental Treatment1 Intervention
Patients diagnosed with Nephrotic syndrome will be in this arm.
Group II: Healthy ArmExperimental Treatment1 Intervention
Healthy volunteers will be in this arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apixaban
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,510 Previous Clinical Trials
4,193,071 Total Patients Enrolled
2 Trials studying Nephrotic Syndrome
28 Patients Enrolled for Nephrotic Syndrome
American College of Clinical PharmacyOTHER
12 Previous Clinical Trials
1,324 Total Patients Enrolled
Daniel Crona, PharmD, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
2 Previous Clinical Trials
66 Total Patients Enrolled
1 Trials studying Nephrotic Syndrome
21 Patients Enrolled for Nephrotic Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this the inaugural instance of such a trial?

"Since 2015, Apixaban 5MG has been researched extensively. Pfizer sponsored the initial trial in 2015 which included 4012 participants - this was followed by Phase 4 approval for use of the drug. Currently there are 47 live studies being conducted for Apixaban 5 MG spanning 379 cities and 34 countries worldwide."

Answered by AI

How many participants are being welcomed into this research endeavor?

"Indeed, the latest figures on clinicaltrials.gov certify that this trial is actively recruiting and has been since April 14th 2021. At present, it necessitates 30 participants to be signed up at a single medical centre."

Answered by AI

Is enrollment for this research endeavor still available?

"Clinicaltrials.gov records show that this trial is still accepting applications, which were initially posted on April 14th 2021 and updated as recently as August 9th 2022."

Answered by AI

To what medical conditions is Apixaban 5 MG typically prescribed?

"Apixaban 5 MG is regularly prescribed to treat atrial fibrillation, but it can also be utilized as a therapeutic option for conditions like deep vein thrombosis, pulmonary embolism and stroke."

Answered by AI

Does this research encompass participants of an advanced age?

"This study is strictly for individuals between 18 and 79 years old. If a participant falls outside of this range, they are still able to participate in other trials; 379 studies accept minors while 1054 clinical trials prioritize geriatric patients."

Answered by AI

What criteria must a participant fulfill in order to be eligible for this trial?

"Patient eligibility for this clinical trial necessitates a diagnosis of nephrotic syndrome and an age between 18 to 79 years. Altogether, 30 participants are being enrolled in the study."

Answered by AI

What kind of safety profile does Apixaban 5 MG possess?

"The safety of Apixaban 5 MG was evaluated to be a 1 on our team's scale due to its Phase 1 status, which suggests low amounts of data regarding efficacy and safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Prospective Multi-dose Study of Apixaban in Subjects With Nephrotic Syndrome
2021. "A Prospective Multi-dose Study of Apixaban in Subjects With Nephrotic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04278729.
~5 spots leftby May 2025
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