Rescue Alkaline Phosphatase In Defense against all cause Acute Kidney Injury
Phase 2
Completed
- Conditions
- acute kidney injury10038430
- Registration Number
- NL-OMON51165
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
• Diagnosed with AKI Stage 2 or 3
• Age 18 years and older
• Written informed consent by patient or representative
Exclusion Criteria
• History of allergy to bovine proteins or strict vagan-/vegetarian diet
• Chronic kidney disease with a baseline eGFR < 20ml/min
• Administration of alkaline phosphatase before, because of a potential
allergic reaction.
• Pregnant or breastfeeding women
• Patients undergoing nephrectomy
• Active malignancy
• Patients expected to have rapidly fatal disease within 24 hours
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome:<br /><br>- Proportion of patients that develop acute kidney disease (AKD) as defined by<br /><br>Acute Disease Quality Initiative (ADQI) 16 workgroup combined with 90 day<br /><br>mortality.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes:<br /><br>- Safety of administration of exogenous AP in the context of AKI (infusion<br /><br>related reactions and side-effects)<br /><br>- Renal function in treatment and placebo group at day 1-7, 28 and 90 and at 1<br /><br>year.<br /><br>- 90 day mortality in treatment group vs placebo group<br /><br>- Microvascular endpoints: angiopoietin 1-2 ratio, S renal residual capacity </p><br>