Clinical trial NCT00683553 (phase 1, status: terminated)
Conditions: acute renal failure, acute kidney injury
ICD codes: N25.0, Q61.4, N23, N26.9, P96.0, Q60.0, Q60.1, N26.2, Q63.0, Q63.2, Z52.4, I75.81, N19, N20.0
Drugs: i5np, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    lack of an available patient population
  
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