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

Phase 2

• Conditions: Coronary Artery Bypass
• Interventions: Drug: Roxadustat; Drug: Placebo

• Registration Number: NCT05010460
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-07
• Study First Submitted QC: 2021-08-10
• Study First Posted: 2021-08-18
• Study Start: 2021-09-30
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-20
• Primary Completion: 2023-08-20
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 318

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Roxadustat	Roxadustat	Roxadustat
placebo	Placebo	Placebo has the same appearance with the experimental drug (Roxadustat).

Primary Outcome Measures

Name	Time	Method
acute kidney injury	0-48 hours after surgery	elevation of serum creatinine ≥0.3mg/dl（26.5μmol/L）or ≥ 1.5 times baseline levels within 48 hours post surgery

Secondary Outcome Measures

Name	Time	Method
classification of acute kidney injury	0-3 days after surgery	classification of of acute kidney injury based on AKIN criteria
renal function	0-3 days after surgery	creatinine, urea, Cystatin-C after surgery
new biomarkers of renal injury	immediately after surgery and the first morning after surgery	serum and urine NGAL，urine TIMP2\*IGFBP7
Cardiac Troponin Subunit I (cTnI)	0-3 days after surgery	peak plasma concentration of cTnI and area under curve (AUC) of cTnI
brain natriuretic peptide (BNP) or N-terminal pro-BNP (NT-proBNP)	0-3 days after surgery	plasma concentration of BNP
death	through study completion, an average of one month	death during hospitalization
length of hospital stay and ICU stay	through study completion, an average of one month	length of hospital stay and ICU stay
Blood infusion	0-3 days after surgery	amount of Red blood cells infusion after surgery
adverse events	through study completion, an average of one month	adverse events and severe adverse events during hospitalization

Trial Locations

Locations (2)

Beijing Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China