Examining the impact of a gene variant on edoxaban effectiveness in patients with kidney issues
Prospective Observational Association Between SLCO1B1 Gene Polymorphism and the Anti-factor Xa Activity of Edoxaban in Patients With Moderate to Severe Renal Insufficiency
Qianfoshan Hospital · NCT06431789
This study is testing how a specific gene variant affects the effectiveness of the blood thinner edoxaban in patients with kidney problems to help find the best dose for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qianfoshan Hospital (other) |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06431789 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with moderate to severe renal insufficiency who are receiving edoxaban, a medication used to prevent blood clots. The research aims to evaluate the safety and effectiveness of edoxaban by analyzing the anti-factor Xa activity in relation to the SLCO1B1 gene polymorphism. By understanding how different genotypes affect drug activity, the study seeks to optimize individualized dosing regimens for better patient outcomes. Participants will be monitored for their response to the medication over a specified period.
Who should consider this trial
Good fit: Ideal candidates include adults with moderate to severe renal insufficiency who are prescribed edoxaban for non-valvular atrial fibrillation or deep vein thrombosis.
Not a fit: Patients under 18 years old or those with specific heart conditions or recent use of certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective dosing of edoxaban for patients with renal insufficiency.
How similar studies have performed: While the approach of examining gene polymorphisms in relation to drug efficacy is established, the specific focus on SLCO1B1 and edoxaban in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Creatinine clearance of 15-50ml/min was calculated according to the Cockcroft-Gault formula * Patients who received edoxaban 30mg once daily for more than 5 days for non-valvular atrial fibrillation (CHADS2VAS2 score ≥2) and deep vein thrombosis prevention or treatment * Patients voluntarily participate and sign informed consent Exclusion Criteria: * Age \< 18 years old * Moderate/severe mitral stenosis combined with valvular heart disease, mechanical valve replacement, or rheumatic heart disease * The patient had used a combination of cyclosporine, erythromycin or ketoconazole or other P-glycoprotein inhibitors within 30 days prior to use or inclusion; Patients were using or had used amiodarone or dronedarone within 30 days prior to inclusion
Where this trial is running
Jinan, Shandong
- First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province ) — Jinan, Shandong, China (RECRUITING)
Study contacts
- Principal investigator: Yi Han, doctorate — Qianfoshan Hospital
- Study coordinator: Yi Han, doctorate
- Email: 15552565120@163.com
- Phone: 15552565120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gene Polymorphism, Edoxaban, Renal Insufficiency, Anti-factor Xa activity, Moderate to severe renal insufficiency, Solute carrier organic anion transporter family member 1B1