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 logo

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

Trial contacts and locations

0

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Central trial contact

Sanxi Ai, Doctor; Yan Qin, Doctor

Data sourced from clinicaltrials.gov

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