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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05010460
Collaborator
Beijing Hospital (Other)
318
Enrollment
2
Locations
2
Arms
25
Anticipated Duration (Months)
159
Patients Per Site
6.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
318 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Roxadustat Reduces the Incidence of Acute Kidney Injury After Coronary Artery Bypass Grafting: a Multicenter, Randomized, Double-blind, Placebo-controlled Study
Actual Study Start Date :
Sep 30, 2021
Anticipated Primary Completion Date :
Aug 20, 2023
Anticipated Study Completion Date :
Oct 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Roxadustat

Roxadustat

Drug: Roxadustat
orally 100mg every other day for 5-8 days prior to CABG
Other Names:
  • Evrenzo

    		•
    Placebo Comparator: placebo

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

    Drug: Placebo
    orally 100mg every other day for 5-8 days prior to CABG

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. classification of acute kidney injury [0-3 days after surgery]

      classification of of acute kidney injury based on AKIN criteria

    2. renal function [0-3 days after surgery]

      creatinine, urea, Cystatin-C after surgery

    3. new biomarkers of renal injury [immediately after surgery and the first morning after surgery]

      serum and urine NGAL，urine TIMP2*IGFBP7

    4. Cardiac Troponin Subunit I (cTnI) [0-3 days after surgery]

      peak plasma concentration of cTnI and area under curve (AUC) of cTnI

    5. brain natriuretic peptide (BNP) or N-terminal pro-BNP (NT-proBNP) [0-3 days after surgery]

      plasma concentration of BNP

    6. death [through study completion, an average of one month]

      death during hospitalization

    7. length of hospital stay and ICU stay [through study completion, an average of one month]

      length of hospital stay and ICU stay

    8. Blood infusion [0-3 days after surgery]

      amount of Red blood cells infusion after surgery

    9. adverse events [through study completion, an average of one month]

      adverse events and severe adverse events during hospitalization

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Hospital Beijing Beijing China 100730
    2 Peking Union Medical College Hospital Beijing Beijing China 100730

    Sponsors and Collaborators

    • Peking Union Medical College Hospital
    • Beijing Hospital

    Investigators

    • Principal Investigator: Yan Qin, Doctor, Peking Union Medical College Hospital
    • Principal Investigator: Qi Miao, Doctor, Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT05010460
    Other Study ID Numbers:
    • ROXAKI
    First Posted:
    Aug 18, 2021
    Last Update Posted:
    Apr 20, 2022
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Peking Union Medical College Hospital
    acute kidney injury
    coronary artery bypass
    Roxadustat
    Additional relevant MeSH terms:
    Acute Kidney Injury

    Study Results

    No Results Posted as of Apr 20, 2022