Rescue alkaline posphatase as a treatment for acute kidney injury
- Conditions
- Acute kidney injuryMedDRA version: 21.1Level: PTClassification code 10069339Term: Acute kidney injurySystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 20.1Level: LLTClassification code 10080269Term: Stage 2 acute kidney injurySystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 20.1Level: LLTClassification code 10080271Term: Stage 3 acute kidney injurySystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2021-002505-10-NL
- Lead Sponsor
- Amsterdam University Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 300
•Diagnosed with AKI Stage 2 or 3
•Age 18 years and older
•Written informed consent by patient or representative
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150
•History of allergy to bovine proteins or strict vegan/vegetarian diet
•Chronic kidney disease with a baseline eGFR < 20ml/min
•History of previous administration of alkaline phosphatase, because of a potential allergic reaction.
•Pregnant or breastfeeding women
•In case of a repeated AKI in one-year follow-up, already included patients are not allowed to receive AP or placebo again.
•Patients undergoing nephrectomy
•Active malignancy or HIV infection
•Patients expected to have rapidly fatal disease within 24 hours
•Pre-existing rapid progressive glomerulonephritis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method