An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery

NCT01256372 | Completed Phase 2 DMC

• 1 other identifier: AP214-CS007
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effect of two dose-levels of AP214 on the prevention of (acute) kidney injury after cardiac surgery.

Conditions

Cardiac Surgery; Coronary Artery Bypass; Aortic Aneurysm; Valve Surgery; Kidney Diseases

Keywords

Cardiac surgery; Acute kidney injury

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability

  To assess the safety and tolerability of AP214 compared to placebo; by analysis of number and nature of Adverse Events (AEs), Serious Adverse Events (SAEs), changes in laboratory parameters and overall health status

  90 days

• Efficacy

  To assess the effect of AP214 versus placebo on the maximal postoperative change in absolute values of Serum Creatinine (SCr) compared to baseline within the first 7 days after surgery or until discharge from hospital, whichever comes first

  7 days

Secondary Outcomes (1)

• Efficacy

  90 days

Study Arms (3)

AP214; dose-level 1

EXPERIMENTAL

AP214; dose-level 1

Drug: AP214

AP214; dose-level 2

EXPERIMENTAL

AP214; dose-level 2

Drug: AP214

Placebo to AP214

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AP214 DRUG

AP214

AP214; dose-level 1; AP214; dose-level 2

Placebo DRUG

Placebo; intravenous infusion

Placebo to AP214

Eligibility Criteria

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

You may qualify if:

• Has signed the trial-specific informed consent form.
• 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.
• Patients undergoing combined coronary artery bypass grafting (CABG) surgery and surgery of one or more cardiac valve (valve(s) surgery), or
• Patients undergoing surgery of more than one cardiac valve (valves surgery), or
• Patients undergoing surgery of the aortic root or ascending part of the aorta, or
• Patients undergoing surgery of the aortic root or ascending part of the aorta, combined with CABG and/or valve(s) surgery, or
• Patients with stage III chronic kidney disease (eGFR 30-59 ml/min determined by the Modification of Diet in Renal Disease (MDRD formula)) undergoing CABG or Valve surgery

You may not qualify if:

• Cardiac surgery to be performed "off pump" without cardiopulmonary bypass.
• Cardiac surgery to be performed with hypothermic circulatory arrest.
• Confirmed or suspected endocarditis.
• EF ≤ 20%, evaluated within 2 months prior to screening visit.
• Requiring a reoperation on one of the valves within 3 months following the original valve surgical procedure.
• Active peptic ulcer disease and gastritis.
• Receiving dopamine, adrenalin or noradrenalin at any dose at any time 14 days prior to Day of surgery.
• Known or suspected hypersensitivity to the investigational medicinal product.
• Current participation in any other interventional clinical trial.
• Previously dosed with AP214.
• Use of investigational medicinal products within the previous 6 months.
• Body weight above 130 kg.
• History of any organ transplant.
• Women who are of childbearing potential, pregnant, or breast-feeding.
• Current abuse of alcohol or substance, according to the investigator's medical judgment.

Sponsors & Collaborators

• Action Pharma A/S: lead

Study Sites (1)

University Hospital Copenhagen, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Aortic Aneurysm; Kidney Diseases; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency

Study Officials

• Action Pharma

  Action Pharma A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2010
• First Posted: December 8, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 15, 2012

Record last verified: 2012-03

Locations

DK (1)