Acute Kidney Diease
Conditions
Interventions
Experimental group:RN-0001 (lyophilized powder injection, 100 mg +/- 1 hour) on Day 1 (4 hours +/- within 1 hour), Day 2 (24 hours +/-1 hour) after first dose), Day 3 (48 hours 1 hour after first dose
Placebo group:RN-0001 compound solvent(injection (vial water injection), 5 g) on Day 1 (4 hours +/- within 1 hour), Day 2 (24 hours +/-1 hour) after first dose), Day 3 (48 hours 1 hour after first dos
Sponsors
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Male or female, aged >= 18 years; 2.Scheduled to undergo surgery involving cardiopulmonary bypass, including one of the following: coronary artery bypass grafting (CABG) surgery; Aortic valve replacement or repair alone, with or without aortic root repair; Mitral, tricuspid, or pulmonic valve replacement or repair alone; Combined replacement of several cardiac valves; CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair; 3.Subjects must have at least one of the following risk factors for AKI prior to surgery: CABG with one or more heart valve surgeries + at least 1 risk factor for AKI*; Several cardiac valves + at least 1 risk factor for AKI; CABG or aortic valve surgery, combined aortic root, ascending aorta, and aortic arch surgery (non-aortic dissection causes) + at least 1 risk factor for AKI; CABG alone or single valve surgery + at least 2 risk factors for AKI. *Risk factors for AKI include, at screening (within 30 days prior to surgery): Age>= 70 years; eGFR= 0.3 g/day, urine albumin-to-creatinine ratio >= 300 mg/g, or urine protein >=+2; History of heart failure requiring hospitalization within 30 days. Note: The eGFR will be calculated using the serum creatinine detected by the enzymatic method, calculated using CKD-EPIscr, see Annex 5 for details. 4.Subjects are able to understand the informed consent form, has the ability to sign informed consent form and comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1.At screening (within 30 days prior to surgery): Use of a ventricular assist device, intra-aortic balloon, or other cardiac device within 7 days prior to screening; Cardiopulmonary resuscitation performed 14 days prior to screening; Patients with renal function instability (creatinine rise >=0.3 mg/dl) or abnormal renal function (eGFR2 times the upper limit of normal or bilirubin elevated >1.5 times the upper limit of normal) at time of screening; Undergoing aortic dissection surgery; Undergoing surgery for complex congenital heart disease (e.g., tetralogy of Fallot, transposition of large vessels, single ventricle, Ebstein anomaly. bicuspid aortic valve is not a congenital heart defect); Requires emergency surgery at screening or surgery in a life-critical situation; Patients with hepatitis B [hepatitis B surface antigen (HBsAg)-positive and detectable HBV RNA]; or hepatitis C patients (hepatitis C virus (HCV) antibodies-positive and detectable HCV RNA]; or positive syphilis (specific antibodies positive, except for the non-specific antibody negative and confirmed as inactive infection based on clinical judgment); or history of human immunodeficiency virus (HIV) infection or positive HIV screening; Patient who has malignancy or history of solid, metastatic or hematologic malignancy within 5 years prior to screening; A history of any organ transplant, or active immunosuppressive treatment; Participated in any other clinical trials (including drugs clinical trials and devices clinical trials) in the last 30 days or 5 drug half-lives (whichever is longer) prior to screening; Pregnant or lactating females, or female subjects who have had unprotected sex within one month prior to screening, or pregnancy test positive; Subjects (or their partners) who have fertility plans or sperm/egg donation throughout the trial period and within 6 months after the end of the study, and who are unwilling to use one or more contraceptive measures during the trial and within 6 months after the end of the study; 2.Preoperative evaluation: Exclusion criteria at screening are also applicable to preoperative evaluation; eGFR <= 60 mL/min/1.73 m^2 requiring intravascular iodinated contrast within 72 hours of the day of surgery; However, patients may have been included if the post contrast increase in SCr was < 0.3 mg/dL in at least 2 SCr evaluations performed not less than 36 hours apart. AKI diagnosed according to KDIGO criteria within 48 hours prior to surgery; 3.General Exclusion Criteria: Previous participation in RN-0001 related studies, known or suspected allergy to any component of RN-0001 injection (including the active ingredient and excipients used in the formulation); Investigators determine that subject is not suitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Creatinine (SCr); | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine volume; | — |
Countries
China
Contacts
Public ContactZheng Zhe
Shenzhen Hospital of Fuwai Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed