A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI

Inclusion Criteria

• Signed Informed Consent Form (patient, legal representative or independent investigator)
• Age 18 to 85 years, inclusive
• Is admitted to the ICU or Intermediate Care Unit
• Has diagnosis of sepsis ( 26.2 µmol/L (0.30 mg/dL) in 48 hrs prior to screening, or
• Increase in serum creatinine to > 150% (> 1.5-fold) from reference creatinine value in 48 hrs prior to screening
• Urinary output 6 hours following adequate fluid resuscitation
• Continuing AKI needs to be confirmed by a confirmative fluid corrected serum creatinine measure, or
• When the AKI diagnosis was made according to the AKIN urine output criteria (urinary output 6 hours), the oliguria or anuria should still meet the AKIN urine output criteria prior to randomization.

Exclusion Criteria

• Woman of childbearing potential with a positive pregnancy test, pregnant, or breastfeeding.
• Weighs more than 115 kg (253 lb).
• Has life support limitations.
• Is known to be human immunodeficiency virus positive.
• Has urosepsis.
• Is already on dialysis (RRT) or anticipated to receive RRT within 24 hours after study drug dosing due to the underlying disease.
• Is receiving immunosuppressant treatment or is on chronic high doses of steroids equivalent to prednisone/prednisolone 0.5 mg/kg/day, including solid organ transplant patients. Patients with septic shock treated with hydrocortisone (e.g., 3 × 100 mg) can be included.
• Is expected to have rapidly fatal outcome (within 24 hours).
• Has known, confirmed fungal sepsis.
• Has advanced chronic liver disease, confirmed by a Child-Pugh score of 10 to 15.
• Has acute pancreatitis with no established source of infection.
• Has participated in another investigational study within 30 days prior to enrollment.
• Is not expected to survive for 28 days due to medical conditions other than SA AKI, including cancer, end-stage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within the past 30 days, end stage lung disease, and end stage liver disease.
• Has known prior history of Chronic Kidney Disease with a documented estimated Glomerular Filtration Rate (eGFR) 150 µmol/L (1.70 mg/dL) for reasons other than the current sepsis condition.
• Has diagnosis of malaria or other parasite infections.
• Has burns on > 20% of body surface.
• Has had AKI diagnosis according to inclusion criteria > 24 hours prior to study drug administration.
• Is anticipated to be treated with non-continuous RRT from Day 1 to Day 7.
• During Day 1 to Day 7 continuous RRT is anticipated to be started or stopped not according to per protocol criteria.
• The AKI is most likely attributable to other causes than sepsis, such as nephrotoxic drugs and renal perfusion-related.
• Improvement in serum creatinine of at least 0.30 mg/dL or (26.2 µmol/L) prior to administration of the study drug.
• Patients who use nephrotoxic medication and who fulfill the SA-AKI inclusion criteria at screening are not eligible if the use of this nephrotoxic medication is to continue when alternative, medically appropriate, non-nephrotoxic medication is available.
• Has a history of known IV drug abuse.
• Is an employee or family member of the investigator or study site personnel.
• Has active hematological malignancy.