NCT05475717

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Contrast-induced Acute Kidney Injury

Interventions

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

Timeline

• Start date: 2022-10-20
• Primary completion: 2023-12-04
• Completion: 2024-01-03
• First posted: 2022-07-27
• Last updated: 2024-11-21

Locations

1 site across 1 country: China