An Trial of Two Dosing Regimens of AP214 for the Preventi... | NCT01256372

NCT01256372

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
AP214	Drug	AP214	AP214; dose-level 1 AP214; dose-level 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Efficacy	To assess the ability of AP214 compared to placebo to reduce postoperative changes in SCr, and eGFR at day 28, 60 and Day 90 and GFR at Day 90 compared to baseline	90 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.
Has a mental incapacity or language barriers precluding adequate understanding of trial procedures.
Any history of cancer within the last 2 years
Any history of dialysis.
Is considered by the Investigator unsuitable to participate in the trial for any other reason, for instance due to a significant serious underlying condition.