AP-recAP-CSA-RD-02-01
Research type
Research Study
Full title
Double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of ilofotase alfa in patients at risk for renal damage following open heart surgery
IRAS ID
1008484
Contact name
Liesbeth Hof
Contact email
Sponsor organisation
AM-Pharma B.V.
Eudract number
2023-505859-45
Clinicaltrials.gov Identifier
Research summary
This study is addressed to patients scheduled for an open heart surgery. Up to 30% of all patients undergoing open heart surgery develop kidney injury after the surgery, while no specific treatments are yet available to prevent this. Ilofotase alfa is a new medicinal product that mimics the alkaline phosphatase protein found in many human tissues. The aim of this study is to find out how well ilofotase alfa is tolerated and if it is effective in reducing the risk of kidney damage after the surgery, safety will also be assessed. Ilofotase alfa is still in development and has not yet been approved for treatment. On top of their standard treatment, study participants will receive either two doses of ilofotase alfa or two doses of placebo as infusion (the placebo does not contain any active ingredient). Neither the patient nor the investigator will know if the patient is receiving ilofotase alfa or placebo (blinded study). Study participation will last approximately 3 months and involve 9 study visits. At least 6 of these visits will take place while the patient is in hospital for open heart surgery. During the study visits, blood tests (at 8 visits), urine analyses (at 6 visits), and an electrocardiogram (at 1 visit) will be performed.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
23/EM/0220
Date of REC Opinion
19 Oct 2023
REC opinion
Further Information Favourable Opinion