Phase 2a/2b study of alkaline phosphatase in patients with SA-AKI
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Four-Arm,Parallel-Group, Proof of Concept, and Dose-Finding Adaptive Phase 2a/2b Study to Investigate the Safety, Tolerability and Efficacy and Effect on Quality of Life of Human Recombinant Alkaline Phosphatase in the Treatment of Patients With Sepsis-Associated Acute Kidney Injury
IRAS ID
158625
Contact name
Mervyn Singer
Contact email
Sponsor organisation
AM-Pharma B.V.
Eudract number
2014-000761-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 3 days
Research summary
Sepsis is a serious condition that occurs when the body reacts severely to an infection. It can result in failure of many of the body’s organs, including the kidney. Sepsis-associated acute kidney injury (SA-AKI) is a serious condition resulting in a death rate of up to 70%, patients who survive are at risk of developing chronic kidney disease (CKD).
Currently there is no specific treatment of SA-AKI, and renal replacement therapy (requiring a dialysis-type machine) is the only supportive option available until the kidney recovers.
Alkaline Phosphatase (AP) is an enzyme present in many human cells and organs and helps the body to fight infection and to reduce body-cell damage. A recombinant (combined genetic material) human AP (recAP) was developed by AM Pharma which is administered in higher than natural levels to patients via intravenous (IV) infusion.
The purpose of this study is to determine if recAP is safe and effective in improving kidney function in patients with SA-AKI, and to determine the effective and safe dose of recAP. The study is in 2 parts. Participants in Part 1 will randomly receive either placebo or 1 of 3 different doses of recAP. In Part 2, participants will receive either placebo or the most effective dose of recap, from part 1.
Participants will be in the study for up to 90 days. There will be a total of 12 visits, daily from Days 1-7, weekly on Days 14, 21 and 28 and follow-up assessments will be on Days 60 and 90. Procedures include: physical examinations, vital signs, electrocardiograms, urine and blood samples for laboratory tests and questionnaires to monitor the disease or side effects of the drug.
This study is sponsored by AM-Pharma B.V., approximately 290 participants will take part in the study, and approximately 20 are expected from the UK.REC name
London - Harrow Research Ethics Committee
REC reference
14/LO/1597
Date of REC Opinion
10 Nov 2014
REC opinion
Further Information Favourable Opinion