Study of Roxadustat for Reducing the Incidence of Acute Kidney Injury After Coronary Artery Bypass Grafting

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2

Conditions: Coronary Artery Bypass

Treatments: Drug: Placebo; Drug: Roxadustat

Study type: Interventional

Funder types: Other

Identifiers

NCT05010460

ROXAKI

Details and patient eligibility

About

Acute kidney injury is a frequent complication after coronary artery bypass grafting (CABG). Roxadustat is a prolyl hydroxylase inhibitor (PHI) which can stabilize hypoxia-inducible factor (HIF) and improve the hypoxic tolerance of tissues. Roxadustat has shown effect in reducing acute kidney injury in animal studies.

This study aims to evaluate the efficacy of administration of Roxadustat before surgery in the prevention of acute kidney injury after CABG.

Full description

Acute kidney injury is a frequent complication after coronary artery bypass grafting (CABG), with a incidence of 28-38%. Renal ischemia-reperfusion injury is the main mechanism for acute kidney injury after CABG.

Roxadustat is a kind of prolyl hydroxylase inhibitor (PHI) which can stabilize hypoxia-inducible factor (HIF) and improve the hypoxic tolerance of tissues. Roxadustat has shown effect in reducing acute kidney injury in animal studies.

This study aims to evaluate the efficacy of administration of Roxadustat (before surgery) in the prevention of acute kidney injury after CABG. This is a multicenter, randomized, double-blind, placebo-controlled study.

Enrollment: 318 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-80 years old
• non-emergent CABG and planned cardiopulmonary bypass (CPB)
• eGFR>15ml/min/1.73m2

Exclusion criteria

• pregnancy or breast feeding
• malignancy
• severe liver dysfunction
• acute kidney injury before randomization
• uncontrolled hypertension

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

318 participants in 2 patient groups, including a placebo group

Roxadustat

Experimental group

Description:

Roxadustat

Treatment:

Drug: Roxadustat

placebo

Placebo Comparator group

Description:

Placebo has the same appearance with the experimental drug (Roxadustat).

Treatment:

Drug: Placebo