Pharmacokinetics of AP214 Acetate in Patients Undergoing Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the present research study is to investigate the pharmacokinetics, as well as safety, tolerability and pharmacodynamics of different ascending dosing regimens of AP214 in patients undergoing cardiac surgery. AP214, the investigational drug, is being developed to potentially prevent post-surgical kidney injury after thoracic aortic aneurysm repair.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety, Tolerability and Pharmacodynamics of AP214 Acetate in Patients Undergoing Cardiac Surgery

NCT00628264

Cardiac Surgery Coronary Artery Bypass Grafting Valve Surgery +1 more

TERMINATED PHASE2

Apixaban Pharmacokinetics in Bariatric Patients (APB)

NCT02406885

Bariatric Surgery Obesity

COMPLETED PHASE4

A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery

NCT04829916

Acute Kidney Injury (AKI)

COMPLETED PHASE1

Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase

NCT03050476

Systemic Inflammation Cardiopulmonary-bypass

RECRUITING PHASE2/PHASE3

Study of NU172 as Anticoagulation in Patients Undergoing Off-pump CABG Surgery

NCT00808964

Heart Disease

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Surgery Coronary Artery Bypass Grafting Valve Surgery Aortic Root or Ascending Aortic Aneurysm Repair Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AP214

Infusions of sequential ascending dosages of AP214

Group Type EXPERIMENTAL

AP214

Intervention Type DRUG

Three 10-minutes infusions of sequential ascending dosages of AP214

Placebo

Infusions of saline solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Three 10-minutes infusions of isotonic saline solution

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AP214

Three 10-minutes infusions of sequential ascending dosages of AP214

Intervention Type DRUG

Placebo

Three 10-minutes infusions of isotonic saline solution

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Has signed the trial-specific informed consent form.
2. Patients ≥ 18 years old, male or female, not of childbearing potential (postmenopausal or permanently sterilized, e.g. tubal ligation, hysterectomy, bilateral salpingectomy), regardless of ethnicity.
3. Patients undergoing CABG, valve(s), CABG/valve(s) and/or aortic root or ascending aortic aneurysm repair surgery.
4. Cleveland Clinic Renal Score ≥ 2 (higher than average risk for AKI).
5. EF ≥ 30%, evaluated within 2 months prior to screening visit.

Exclusion Criteria

1. Cardiac surgery to be performed "off pump" without cardiopulmonary bypass.
2. Circulatory arrest in connection with aortic root or ascending aortic aneurysm repair surgery.
3. Confirmed or suspected endocarditis.
4. Requiring a reoperation on one of the valves within 3 months following the original valve surgical procedure.
5. Receiving Aprotinin during the trial, from Screening to Day 90.
6. Having undergone cardiovascular catheterization ≤ 48 hours prior to scheduled surgery.
7. Active peptic ulcer disease and gastritis.
8. Hemoccult positive stools, hematological, bleeding, and coagulation disorders.
9. Receiving dopamine at renal doses (2-4 mcg/kg/min), from Screening to Day of surgery.
10. S-Creatinine greater than 2.1 mg/dl.
11. Known or suspected hypersensitivity to the investigational medicinal product.
12. Known or suspected hypersensitivity to Ondansetron or other selective 5-hydroxytryptamine 3 (5-HT3) receptor antagonists.
13. Current participation in any other interventional clinical trial.
14. Previously dosed with AP214.
15. Use of investigational medicinal products within the previous 6 months.
16. Body weight above 140 kg.
17. History of any organ transplant.
18. Women who are of childbearing potential, pregnant, or breast-feeding.
19. Current abuse of alcohol or substance, according to the investigator's medical judgment.
20. Has a mental incapacity or language barriers precluding adequate understanding of trial procedures.
21. Is considered by the Investigator unsuitable to participate in the trial for any other reason, for instance due to a significant serious underlying condition.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No