## Protocol Section
### Identification Module
**NCT ID:** NCT06431789

**Brief Title:** Prospective Observational Association Between SLCO1B1 Gene Polymorphism and the Anti-factor Xa Activity of Edoxaban in Patients With Moderate to Severe Renal Insufficiency

**Official Title:** Prospective Observational Association Between SLCO1B1 Gene Polymorphism and the Anti-factor Xa Activity of Edoxaban in Patients With Moderate to Severe Renal Insufficiency

#### Organization Study ID Info
**ID:** SLCO1B1
#### Organization
**Class:** OTHER
**Full Name:** Qianfoshan Hospital
### Status Module
#### Completion Date
**Date:** 2026-04-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-10-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Qianfoshan Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Yi Han

#### Responsible Party

**Investigator Affiliation:** Qianfoshan Hospital

**Investigator Full Name:** Yi Han

**Investigator Title:** Associate professor of pharmacy

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 1. To provide reference for clinical rational use of edoxaban;
2. Optimize the individualized dosing regimen of edoxaban.

**Detailed Description:** In this study, patients with moderate and severe renal insufficiency receiving edoxaban were selected as research objects. The potential safety of edoxaban in patients with different genotypes was evaluated by detecting the anti-XA factor activity and SLCO1B1 genotyping, so as to optimize the individualized administration regimen of edoxaban.

### Conditions Module

**Conditions:**

- Gene Polymorphism

- Edoxaban

- Renal Insufficiency

**Keywords:**

- Anti-factor Xa activity

- Edoxaban

- Moderate to severe renal insufficiency

- Solute carrier organic anion transporter family member 1B1

### Design Module

#### Bio Spec

**Description:** blood

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 220

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Other Outcomes

**Description:** Thrombotic and bleeding events.

**Measure:** Safety index:Thrombotic and bleeding events.

**Time Frame:** six months

#### Primary Outcomes

**Description:** Anti-factor Xa activity

**Measure:** Anti-factor Xa activity

**Time Frame:** six months

### Eligibility Module

**Eligibility 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients treated with edoxaban at the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfo Hospital).

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** 15552565120@163.com

**Name:** Yi Han, doctorate

**Phone:** 15552565120

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Jinan

**Contacts:**

***Contact 1:***

- **Email:** 15552565120@163.com

- **Name:** Yi Han, doctorate

- **Phone:** 15552565120

- **Role:** CONTACT

**Country:** China

**Facility:** First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )

**State:** Shandong

**Status:** RECRUITING

**Zip:** 250014

#### Overall Officials

**Official 1:**

**Affiliation:** Qianfoshan Hospital

**Name:** Yi Han, doctorate

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M26718

- Name: Renal Insufficiency

- Relevance: HIGH

- As Found: Renal Insufficiency

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000051437

- Term: Renal Insufficiency

### Intervention Browse Module - Browse Branches

- Abbrev: AnCoag

- Name: Anticoagulants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M261011

- Name: Edoxaban

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
