A Study to Explore the Efficacy of Alprostadil Liposomes Injection in the Prevention of CI-AKI

NCT05475717 | Terminated Phase 2 DMC

• 1 other identifier: HF1307-004
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, open-label phase II clinical trial to evaluate alprostadil liposomal injection in the prevention of contrast-induced acute kidney injury in patients undergoing percutaneous coronary intervention.

Conditions

Contrast-induced Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Incidence of contrast-induced acute kidney injury within 72 hours after PCI

  Incidence of contrast-induced acute kidney injury within 72 hours after PCI

  from baseline to 72 hours after PCI

Secondary Outcomes (8)

• Changes in serum creatinine from baseline at 24 hours, 48 hours, and 72 hours after angiography

  from baseline to 72 hours after angiography

• Changes in blood urea nitrogen from baseline at 24 hours, 48 hours, and 72 hours after angiography

  from baseline to 72 hours after angiography

• Changes in cystatin C from baseline at 24 hours, 48 hours, and 72 hours after angiography

  from baseline to 72 hours after angiography

• Changes in hs-CRP from baseline at 24 hours, 48 hours, and 72 hours after angiography

  from baseline to 72 hours after angiography

• Changes in IL-6 from baseline at 24 hours, 48 hours, and 72 hours after angiography

  from baseline to 72 hours after angiography

Study Arms (4)

20 µg group

EXPERIMENTAL

Patients will receive alprostadil liposome injection at 20 µg once daily (QD) for 4 days (1 to 3 hours before surgery and 3 days after surgery).

Drug: Alprostadil liposome injection

40 µg group

EXPERIMENTAL

Patients will receive alprostadil liposome injection at 40 µg once daily (QD) for 4 days (1 to 3 hours before surgery and 3 days after surgery)

Drug: Alprostadil liposome injection

80 µg group

EXPERIMENTAL

Patients will receive alprostadil liposome injection at 80 µg once daily (QD) for 4 days (1 to 3 hours before surgery and 3 days after surgery)

Drug: Alprostadil liposome injection

blank control group

NO INTERVENTION

Patients will receive only basic hydration therapy which the experimental groups will receive.

Interventions

Alprostadil liposome injection DRUG

Alprostadil liposome injection, iv drip, QD×4 days (1 to 3 hours before surgery and 3 days after surgery)

Also known as: Alprostadil liposome

20 µg group; 40 µg group; 80 µg group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Agree to participate in this clinical trial and sign the informed consent voluntarily; 2.18≤age≤80 years old, gender is not limited; 3.Suffering from coronary artery disease and preparing to undergo elective PCI; 4.Serum creatinine\>1.5 mg/dL or 30≤eGFR\<60 mL/(min·1.73m\^2), and meet at least one of the following risk factors:
• Cardiac function class NYHA class III;
• Age \> 75 years old;
• Anemia (baseline hematocrit: \<36% in women, \<39% in men);
• Diabetes.

You may not qualify if:

• Pre-perform emergency PCI;
• Previously allergic to alprostadil similar products and contrast agents; used alprostadil within 3 days before the first administration;
• Severe renal insufficiency: renal replacement therapy may be performed in a short period of time or eGFR\<30 mL/(min·1.73m\^2);
• Severe heart failure (LVEF \<35% or NYHA class IV), acute heart failure, and pulmonary edema;
• Requires mechanical circulatory support therapy (intra-aortic balloon pump, catheter-based ventricular assist device, venous-arterial extracorporeal membrane oxygenation therapy, etc.);
• Hypotension: systolic blood pressure \< 90 mmHg;
• Acute bleeding disorders or bleeding tendency, and the investigators believe that they are not suitable to participate in this trial;
• Severe anemia (hemoglobin \<60 g/L);
• Active hepatitis B virus infection (positive hepatitis B virus surface antigen and the quantitative detection value of hepatitis B virus DNA exceeds the upper limit of the normal range of the research center), positive for any one of hepatitis C virus antibody, HIV antibody, and Treponema pallidum antibody;
• Abnormal liver function (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times the upper limit of normal);
• Contrast agents or known nephrotoxic drugs (aminoglycoside antibiotics, amphotericin B, vancomycin, antiviral drugs, non-steroidal anti-inflammatory drugs (except aspirin), Immunosuppressants, traditional Chinese medicines and proprietary Chinese medicines containing aristolochic acid, etc.) within 14 days before the first application of the test drug, or the use of drugs that protect the kidneys against AKI (N-acetylcysteine, sodium bicarbonate, aminophylline) within 3 days before the first application of the test drug;
• Severe renal artery stenosis, and in the opinion of the the investigator, is unsuitable to participate in this trial;
• Electrolyte disorders (serum potassium \<2.5 mmol/L or serum sodium \<125 mmol/L);
• A history of glaucoma or ocular hypertension or gastric ulcer;
• Interstitial pneumonia or mental illness or dementia;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Beijing University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Study Officials

• Wen Xu, Derector

  CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 27, 2022
• Study Start: October 20, 2022
• Primary Completion: December 4, 2023
• Study Completion: January 3, 2024
• Last Updated: November 21, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)