October 1, 2024. Alloksys anticipates that in the just started continuation of the APPIRED III study (a placebo-controlled combined phase IIb / III trial), with longer administration of RESCAP® (up to 96 hours), benefits such as accelerated recovery and reduced acute kidney injury (AKI) is expected in all patients with underlying Chronic Kidney Disease (CKD) to be enrolled, further confirming the results of the interim analyses on the first 271 patients enrolled.
Description of the study
The APPIRED III study will be continued on three arms: A, B and C.
In arm A, 150 patients with a relative normal kidney function (CKD 1 and 2) prior to surgery will be treated with 10,000 IU within 24 hours (in the RESCAP® group), which corresponds to the treatment of the first part of the APPIRED III study. This phase III study arm aims to validate the effects on reduced AKI and duration to reach stability and on liver parameters found in the first part.
In arm B, 200 patients with reduced kidney function before surgery (CKD>2) will be treated for four days with 10,000 IU per day (in the RESCAP® group). This phase IIb study arm aims to investigate whether a prolonged treatment will have an outcome effect on CKD stage >2 patients (In the first part, this patient group did not show an improvement with only 24 hours of RESCAP treatment).
In arm C, 100 patients with CKD stage 1 or 2 will be treated for four days with 10,000 IU per day (in the RESCAP® group). This phase IIb study part aims to investigate whether a prolonged administration will have an additional meliorating outcome effect.
Study director and Involved clinical centers
The study director/principle investigator of the study is Dr Dominik Wiedemann, head of the Cardiac Surgery Department of the University Clinic St Pölten, Austria.
Various clinical centers in Austria, the Netherlands, and Belgium, take part of the study. Alloksys aims to further extend the number of participating hospitals.
Planning
Alloksys expects to finish the study in 2027.
