Trial Search Results

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

The purpose of this study is to determine whether recombinant Alkaline Phosphatase (recAP) is effective and save, and to determine the most effective dose, in the treatment of patients with acute kidney injury caused by sepsis.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

AM-Pharma

Collaborator: PPD

Stanford Investigator(s):

Intervention(s):

  • Biological: recAP
  • Other: Placebo

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   1. Signed Informed Consent Form (patient, legal representative or independent
   investigator)

   2. Age 18 to 85 years, inclusive

   3. Is admitted to the ICU or Intermediate Care Unit

   4. Has diagnosis of sepsis (< 96 hrs prior to first study drug), according to criteria
   defined by the American College of Chest Physicians/Society of Critical Care Medicine:

      1. Has a proven or strongly suspected bacterial infection.

      2. Has at least 2 of 4 SIRS criteria 72 hrs < screening and 96 hrs < first study
      drug

   5. First diagnosis of AKI: AKI Stage 1 or greater, according to the AKIN criteria
   (time-window adjusted):

      1. Increase in serum creatinine > 26.2 µmol/L (0.30 mg/dL) in 48 hrs prior to
      screening, or

      2. Increase in serum creatinine to > 150% (> 1.5-fold) from reference creatinine
      value in 48 hrs prior to screening

      3. Urinary output < 0.5 mL/kg/h for > 6 hours following adequate fluid resuscitation

   6. Continuing AKI needs to be confirmed by a confirmative fluid corrected serum
   creatinine measure, or

   7. When the AKI diagnosis was made according to the AKIN urine output criteria (urinary
   output < 0.5 mL/kg/h for > 6 hours), the oliguria or anuria should still meet the AKIN
   urine output criteria prior to randomization.

Exclusion Criteria:

   1. Woman of childbearing potential with a positive pregnancy test, pregnant, or
   breastfeeding.

   2. Weighs more than 115 kg (253 lb).

   3. Has life support limitations.

   4. Is known to be human immunodeficiency virus positive.

   5. Has urosepsis.

   6. Is already on dialysis (RRT) or anticipated to receive RRT within 24 hours after study
   drug dosing due to the underlying disease.

   7. 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.

   8. Is expected to have rapidly fatal outcome (within 24 hours).

   9. Has known, confirmed fungal sepsis.

10. Has advanced chronic liver disease, confirmed by a Child-Pugh score of 10 to 15.

11. Has acute pancreatitis with no established source of infection.

12. Has participated in another investigational study within 30 days prior to enrollment.

13. 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.

14. Has known prior history of Chronic Kidney Disease with a documented estimated
   Glomerular Filtration Rate (eGFR) < 60 mL/min by Modification of Diet in Renal Disease
   MDRD or CKD-EPI formula, known GFR < 60 mL/min, or a known history of persistent
   creatinine level > 150 µmol/L (1.70 mg/dL) for reasons other than the current sepsis
   condition.

15. Has diagnosis of malaria or other parasite infections.

16. Has burns on > 20% of body surface.

17. Has had AKI diagnosis according to inclusion criteria > 24 hours prior to study drug
   administration.

18. Is anticipated to be treated with non-continuous RRT from Day 1 to Day 7.

19. During Day 1 to Day 7 continuous RRT is anticipated to be started or stopped not
   according to per protocol criteria.

20. The AKI is most likely attributable to other causes than sepsis, such as nephrotoxic
   drugs and renal perfusion-related.

21. Improvement in serum creatinine of at least 0.30 mg/dL or (26.2 µmol/L) prior to
   administration of the study drug.

22. 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.

23. Has a history of known IV drug abuse.

24. Is an employee or family member of the investigator or study site personnel.

25. Has active hematological malignancy.

Ages Eligible for Study

18 Years - 85 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting