Please assess the completion status of the following clinical trial:

Trial Title: A Dose Escalation and Safety Study of I5NP to Prevent Acute Kidney Injury (AKI) in Patients at High Risk of AKI Undergoing Major Cardiovascular Surgery (QRK.004)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: PREVENTION
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE1
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria (before surgery):~* Patient age between 21 years and 85 years old~* Patient is capable of giving consent~* Patient is willing and able to comply with the visit schedule and study procedures including post-hospitalization discharge follow-up~* Patient is undergoing any major cardiac or vascular surgery requiring the use of cardiopulmonary bypass machine (CBM)~* Patient has a cumulative score of ≥ 5 on the Cleveland Clinic Foundation (CCF) Acute Kidney Injury (AKI) risk factor scale OR the patient has an estimated GFR (eGFR) \<60 mL/min/1.73 m2, as determined from the simplified (4-variable) MDRD (Modification of Diet in Renal Disease) equation at the time of the Screening/Baseline examination~* The patient reports that they are up to date and have had normal findings on their age- and sex-appropriate cancer screening, per American Cancer Society guidelines, for breast cancer, cervical cancer, rectal cancer, and prostate cancer. If a patient is not up to date, the relevant screening test must be performed and a normal result documented prior to dosing.~Inclusion Criteria (during surgery):~* Patient must have been on cardiopulmonary bypass machine (CBM)~Inclusion Criteria (after surgery):~* Patient must be in the ICU for dosing to facilitate study procedures including PK blood draws and PK urine sampling~Exclusion Criteria (before surgery):~* Patient has had cancer or may be predisposed due to a family history of:~  * a clinical syndrome predisposing to malignancy, such as Familial Polyposis Coli, Von Hippel Landau disease (associated with renal cell cancers and renal cysts) and Li-Fraumeni syndrome (associated with inherited mutations of the p53 tumor-suppressor gene)~ * the same malignancy in two or more first- or second-degree relatives~* Patient has a history of any abnormality on chest X-ray that could represent a malignancy~* Patient has a clinically significantly elevated pancreatic and/or hepatic enzyme level, defined as any grade 2, 3 or 4 value according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 3.0~* Women of childbearing potential are to be excluded from this study. Every female subject is considered of childbearing potential unless she has had sterilization surgery, or is post-menopausal.~  * Women 21-59, post-menopausal is defined as no menses for at least 12 months and an elevated follicle stimulating hormone (FSH) level.~ * Women 60-85, post-menopausal is defined as no menses in at least 12 months.~* Patient has participated in a study of an experimental therapy in the last 30 days~* Patient is currently receiving immunosuppressive therapy \[this criterion does NOT apply to topical steroids and inhalation steroids for chronic obstructive pulmonary disease (COPD) and/or asthma\]~* Pre-operative extracorporeal membrane oxygenation~* Patient has Intra-Arterial Balloon Pump (IABP) or other Left Ventricular Assist Device (LVAD)~* Evidence that patient is experiencing possible AKI prior to surgery, defined as a \> 1.5 times increase in serum creatinine from screening to any time prior to surgery~* Patient has comfort measures only or do not resuscitate (DNR) status~* Patient is participating in a concurrent interventional study~* Patient has received intravenous contrast material \< 24 hours prior to surgery~* In the opinion of the investigator a pre-operative concomitant disease or clinical/laboratory finding that significantly raises the risk of complications in the post-operative period and therefore precludes dosing of the patient~Exclusion Criteria (during surgery):~* In the opinion of the investigator, an intra-operative complication has occurred that significantly raises the risk of complications in the post operative period and therefore precludes dosing of the patient~Exclusion Criteria (after surgery):~* In the opinion of the investigator, a complication has occurred in the post-operative period at any time prior to dosing that significantly raises the risk of further complications and therefore precludes dosing of the patient

- Gender: ALL
- Minimum Age: 21 Years
- Maximum Age: 85 Years
- Healthy Volunteers: f

Study Arms:
- I5NP drug (Type: EXPERIMENTAL): None
- Placebo (Type: PLACEBO_COMPARATOR): None

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: terminate
termination_type: enrollment issues