A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With S… (NCT02182440) | Clinical Trial Compass
CompletedPhase 2
A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI
United States, Austria, Belgium301 participantsStarted 2014-12-18
Plain-language summary
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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (\< 96 hrs prior to first study drug), according to criteria defined by the American College of Chest Physicians/Society of Critical Care Medicine:
. Has a proven or strongly suspected bacterial infection.
. Has at least 2 of 4 SIRS criteria 72 hrs \< screening and 96 hrs \< first study drug
. First diagnosis of AKI: AKI Stage 1 or greater, according to the AKIN criteria (time-window adjusted):
. Increase in serum creatinine \> 26.2 µmol/L (0.30 mg/dL) in 48 hrs prior to screening, or
Exclusion criteria
. Woman of childbearing potential with a positive pregnancy test, pregnant, or breastfeeding.
. Weighs more than 115 kg (253 lb).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area Under the Time Corrected Endogenous Creatinine Clearance From Day 1 to Day 7 (AUC1-7)
. 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).