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Contrast-induced Acute Kidney InjuryPhase 2NCT05475717

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

A Phase 2 study testing Alprostadil liposome injection in people with Contrast-induced Acute Kidney Injury, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Contrast-induced Acute Kidney Injury
What is being tested?
Alprostadil liposome injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
1 siteChina
Study dates
20 Oct 2022to 3 Jan 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing University First Hospital

    Beijing, Beijing Municipality, 100034

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Alprostadil liposome injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alprostadil liposome injectionDrug

    Also called Alprostadil liposome

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

Study groups in NCT05475717
Study groupRoleWhat they receive
20 µg groupExperimentalPatients 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).
Receives: Drug: Alprostadil liposome injection
40 µg groupExperimentalPatients 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)
Receives: Drug: Alprostadil liposome injection
80 µg groupExperimentalPatients 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)
Receives: Drug: Alprostadil liposome injection
blank control groupNo interventionPatients will receive only basic hydration therapy which the experimental groups will receive.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: from baseline to 72 hours after PCI

Secondary outcomes (8)

  1. 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

    Measured: from baseline to 72 hours after angiography

  2. 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

    Measured: from baseline to 72 hours after angiography

  3. 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

    Measured: from baseline to 72 hours after angiography

  4. 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

    Measured: from baseline to 72 hours after angiography

  5. 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

    Measured: from baseline to 72 hours after angiography

  6. Incidence of renal replacement therapy after angiography during the study period

    Incidence of renal replacement therapy after angiography during the study

    Measured: from baseline to 7 days after last dose

  7. Adverse events

    Adverse events from baseline to 7 days after last dose, including symptoms, Abnormal laboratory test

    Measured: from baseline to 7 days after last dose

  8. 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)

    Measured: from baseline to 7 days after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2022
  2. Study start20 Oct 2022
  3. Primary completion4 Dec 2023
  4. Study completion3 Jan 2024

Why it stopped: Voluntarily suspended the trial due to strategic adjustments

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05475717
Sponsor's protocol ID
HF1307-004
Status last verified
Oct 2022
First submitted
20 Jul 2022
Last updated
21 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alprostadil liposome injection in people with Contrast-induced Acute Kidney Injury, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Voluntarily suspended the trial due to strategic adjustments). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of contrast-induced acute kidney injury within 72 hours after PCI (time frame: from baseline to 72 hours after PCI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05475717.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.

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