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

Primary Purpose

Contrast-induced Acute Kidney Injury

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Alprostadil liposome injection
Sponsored by
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contrast-induced Acute Kidney Injury

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. 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:

  1. Cardiac function class NYHA class III;
  2. Age > 75 years old;
  3. Anemia (baseline hematocrit: <36% in women, <39% in men);
  4. Diabetes.

Exclusion Criteria:

  1. Pre-perform emergency PCI;
  2. Previously allergic to alprostadil similar products and contrast agents; used alprostadil within 3 days before the first administration;
  3. Severe renal insufficiency: renal replacement therapy may be performed in a short period of time or eGFR<30 mL/(min·1.73m^2);
  4. Severe heart failure (LVEF <35% or NYHA class IV), acute heart failure, and pulmonary edema;
  5. Requires mechanical circulatory support therapy (intra-aortic balloon pump, catheter-based ventricular assist device, venous-arterial extracorporeal membrane oxygenation therapy, etc.);
  6. Hypotension: systolic blood pressure < 90 mmHg;
  7. Acute bleeding disorders or bleeding tendency, and the investigators believe that they are not suitable to participate in this trial;
  8. Severe anemia (hemoglobin <60 g/L);
  9. 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;
  10. Abnormal liver function (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times the upper limit of normal);
  11. 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;
  12. Severe renal artery stenosis, and in the opinion of the the investigator, is unsuitable to participate in this trial;
  13. Electrolyte disorders (serum potassium <2.5 mmol/L or serum sodium <125 mmol/L);
  14. A history of glaucoma or ocular hypertension or gastric ulcer;
  15. Interstitial pneumonia or mental illness or dementia;
  16. Malignant tumors;
  17. Have participated in drug clinical trials and used drugs within 3 months before screening;
  18. Pregnant or breastfeeding, or patients who cannot use effective contraception during the study;
  19. Other patients deemed unsuitable for participation in this trial by the investigator.

Sites / Locations

  • Beijing University First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

20 µg group

40 µg group

80 µg group

blank control group

Arm Description

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).

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)

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)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in serum creatinine from baseline at 24 hours, 48 hours, and 72 hours after angiography
Changes in serum creatinine from baseline at 24 hours, 48 hours, and 72 hours after angiography
Changes in blood urea nitrogen from baseline at 24 hours, 48 hours, and 72 hours after angiography
Changes in blood urea nitrogen from baseline at 24 hours, 48 hours, and 72 hours after angiography
Changes in cystatin C from baseline at 24 hours, 48 hours, and 72 hours after angiography
Changes in cystatin C from baseline at 24 hours, 48 hours, and 72 hours after angiography
Changes in hs-CRP from baseline at 24 hours, 48 hours, and 72 hours after angiography
Changes in hs-CRP from baseline at 24 hours, 48 hours, and 72 hours after angiography
Changes in IL-6 from baseline at 24 hours, 48 hours, and 72 hours after angiography
Changes in IL-6 from baseline at 24 hours, 48 hours, and 72 hours after angiography
Incidence of renal replacement therapy after angiography during the study period
Incidence of renal replacement therapy after angiography during the study
Adverse events
Adverse events from baseline to 7 days after last dose, including symptoms, Abnormal laboratory test
Incidence of major adverse cardiovascular events (MACE) during the study period (recurrent angina, nonfatal myocardial infarction, acute heart failure, ventricular fibrillation, cardiac death)
Incidence of major adverse cardiovascular events (MACE) during the study period (recurrent angina, nonfatal myocardial infarction, acute heart failure, ventricular fibrillation, cardiac death)

Full Information

First Posted
July 20, 2022
Last Updated
October 26, 2022
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05475717
Brief Title
A Study to Explore the Efficacy of Alprostadil Liposomes Injection in the Prevention of CI-AKI
Official Title
A Multicenter, Randomized, Open-label Phase II Clinical Trial Evaluating Alprostadil Liposomal Injection in the Prevention of Contrast-induced Acute Kidney Injury in Patients Undergoing Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The trial is a multicenter, randomized, open-label, two-stage study. The trial period includes a screening period (up to 14 days), a treatment period (4 days), and a safety follow-up period (7 days ± 3 days). At least 368 patients with pre-PCI (percutaneous coronary intervention) are expected to be included, and all patients will be contrasted with non-ionic hypotonic/isotonic contrast media. The trail will be divided into two stages. Three dose groups are set in the first stage: 20 µg/day, 40 µg/day and 80 µg/day. In the first stage, on the basis of hydration prevention, patients will randomized to receive 20, 40 or 80 µg/day of alprostadil liposome injection for 4 days (1 to 3 hours before surgery and 3 days after surgery), once a day. The blank control group will only receive hydration prophylaxis. In the second stage, according to the comprehensive evaluation of the data in the first stage, a dose group will be selected to continue to be enrolled. The primary outcome measure is the incidence of contrast-induced acute kidney injury within 72 hours after PCI. During the administration of alprostadil liposomal injection, vital signs, physical examination, ECOG performance status, laboratory test, ECG, adverse events and PK parameters will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast-induced Acute Kidney Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
368 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
20 µg group
Arm Type
Experimental
Arm Description
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).
Arm Title
40 µg group
Arm Type
Experimental
Arm Description
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)
Arm Title
80 µg group
Arm Type
Experimental
Arm Description
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)
Arm Title
blank control group
Arm Type
No Intervention
Arm Description
Patients will receive only basic hydration therapy which the experimental groups will receive.
Intervention Type
Drug
Intervention Name(s)
Alprostadil liposome injection
Other Intervention Name(s)
Alprostadil liposome
Intervention Description
Alprostadil liposome injection, iv drip, QD×4 days (1 to 3 hours before surgery and 3 days after surgery)
Primary Outcome Measure Information:
Title
Incidence of contrast-induced acute kidney injury within 72 hours after PCI
Description
Incidence of contrast-induced acute kidney injury within 72 hours after PCI
Time Frame
from baseline to 72 hours after PCI
Secondary Outcome Measure Information:
Title
Changes in serum creatinine from baseline at 24 hours, 48 hours, and 72 hours after angiography
Description
Changes in serum creatinine from baseline at 24 hours, 48 hours, and 72 hours after angiography
Time Frame
from baseline to 72 hours after angiography
Title
Changes in blood urea nitrogen from baseline at 24 hours, 48 hours, and 72 hours after angiography
Description
Changes in blood urea nitrogen from baseline at 24 hours, 48 hours, and 72 hours after angiography
Time Frame
from baseline to 72 hours after angiography
Title
Changes in cystatin C from baseline at 24 hours, 48 hours, and 72 hours after angiography
Description
Changes in cystatin C from baseline at 24 hours, 48 hours, and 72 hours after angiography
Time Frame
from baseline to 72 hours after angiography
Title
Changes in hs-CRP from baseline at 24 hours, 48 hours, and 72 hours after angiography
Description
Changes in hs-CRP from baseline at 24 hours, 48 hours, and 72 hours after angiography
Time Frame
from baseline to 72 hours after angiography
Title
Changes in IL-6 from baseline at 24 hours, 48 hours, and 72 hours after angiography
Description
Changes in IL-6 from baseline at 24 hours, 48 hours, and 72 hours after angiography
Time Frame
from baseline to 72 hours after angiography
Title
Incidence of renal replacement therapy after angiography during the study period
Description
Incidence of renal replacement therapy after angiography during the study
Time Frame
from baseline to 7 days after last dose
Title
Adverse events
Description
Adverse events from baseline to 7 days after last dose, including symptoms, Abnormal laboratory test
Time Frame
from baseline to 7 days after last dose
Title
Incidence of major adverse cardiovascular events (MACE) during the study period (recurrent angina, nonfatal myocardial infarction, acute heart failure, ventricular fibrillation, cardiac death)
Description
Incidence of major adverse cardiovascular events (MACE) during the study period (recurrent angina, nonfatal myocardial infarction, acute heart failure, ventricular fibrillation, cardiac death)
Time Frame
from baseline to 7 days after last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. 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. Exclusion Criteria: 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; Malignant tumors; Have participated in drug clinical trials and used drugs within 3 months before screening; Pregnant or breastfeeding, or patients who cannot use effective contraception during the study; Other patients deemed unsuitable for participation in this trial by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Huo, professor
Phone
+86-010-83572283
Email
huoyong@263.net.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Xu, Derector
Organizational Affiliation
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Beijing University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Huo, Professor
Phone
+86-010-83572283
Email
huoyong@263.net.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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