Action Pharma is developing AP214 Acetate for the prevention of postsurgical kidney injury after cardiac surgery. Trial population is patients with increased risk for development of Kidney Injury after cardiac surgery with extracorporal circulation. MedDRA version: 13.1 Level: PT Classification code 10056675 Term: Postoperative renal failure System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Product Name: AP214 Acetate
Product Code: AP214
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: AP214
Other descriptive name: Synthetic Melanocortin Analogue
Concentra
Sponsors
Action Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Has signed the trial-specific informed consent form. 2. Patients = 18 years old, male or female, not of childbearing potential (postmenopausal or permanently sterilized, e.g. tubal ligation, hysterectomy, bilateral salpingectomy), regardless of ethnicity. 3. Patients undergoing combined coronary artery bypass grafting (CABG) surgery and surgery of one or more cardiac valve (valve(s) surgery), or 4. Patients undergoing surgery of more than one cardiac valve (valves surgery), or 5. Patients undergoing surgery of the aortic root or ascending part of the aorta, or 6. Patients undergoing surgery of the aortic root or ascending part of the aorta, combined with CABG and/or valve(s) surgery, or 7. Patients with stage III chronic kidney disease (eGFR 30-59 ml/min determined by the Modification of Diet in Renal Disease (MDRD) undergoing CABG or Single Valve surgery Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Cardiac surgery to be performed “off pump” without cardiopulmonary bypass. 2. Cardiac surgery to be performed with hypothermic circulatory arrest. 3. Confirmed or suspected endocarditis. 4. EF = 20%, evaluated within 2 months prior to screening visit. 5. Requiring a reoperation on one of the valves within 3 months following the original valve surgical procedure. 6. Active peptic ulcer disease and gastritis. 7. Receiving dopamine, adrenalin or noradrenalin at any dose at any time 14 days prior to Day of surgery. 8. Known or suspected hypersensitivity to the investigational medicinal product. 9. Current participation in any other interventional clinical trial. 10. Previously dosed with AP214. 11. Use of investigational medicinal products within the previous 6 months. 12. Body weight above 130 kg. 13. History of any organ transplant. 14. Women who are of childbearing potential, pregnant, or breast-feeding. 15. Current abuse of alcohol or substance, according to the investigator’s medical judgment. 16. Has a mental incapacity or language barriers precluding adequate understanding of trial procedures. 17. Any history of cancer within the last 2 years 18. Any history of dialysis. 19. Is considered by the Investigator unsuitable to participate in the trial for any other reason, for instance due to a significant serious underlying condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety To assess the safety and tolerability of AP214 compared to placebo Efficacy To assess the effect of AP214 versus placebo on the maximal postoperative change in absolute values of Serum Creatinine (SCr) compared to baseline within the first 7 days after surgery or until discharge from hospital, whichever comes first. ;Secondary Objective: To assess the ability of AP214 compared to placebo to reduce postoperative changes in GFR, SCr and eGFR compared to baseline. To assess the proportion of AP214 treated patients compared to placebo developing postoperative acute kidney (AKI) injury according to the RIFLE and AKIN score. To assess the proportion of patients reaching the composite endpoint of death, need of renal replacement therapy (RRT) or a 25% reduction in renal function when compared to placebo treatment over a 90 day postoperative period. To compare the ability of the two AP214 dosing regimens to protect against development of post surgical changes in renal function. - on the maximal postoperative change in absolute values of SCr; - on post operative changes in GFR and eGFR - in the proportion of patients developing AKI according to the RIFLE and AKIN score To compare the ability of the two AP214 dosing regimens to reduce postoperative changes in SCr, eGFR and GFR compared to baseline.;Primary end point(s): Primary endpoint: Efficacy:Changes in sCR within 7 days after surgery; Safety: Safety Day 0-7 and 0-90. ;Timepoint(s) of evaluation of this end point: Please check above. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: - changes in GFR at Day 3 or 4 and eGFR at Day 0-7 compared to baseline - changes in sCr and eGFR at Days 28, 60 and 90 - proportion of AP214 treated patients compared to placebo developing postoperative acute kidney injury according to the Rifle score - proportion of AP214 patients compared to placebo developing postoperative acute kidney injury according to AKIN criteria - proportion of AP214 patients reaching the composite endpoint of death, need of renal replacement therapy or a 25% reduction in renal function when compared to placebo over the 90 day postoperative period ;Timepoint(s) of evaluation of this end point: Please check above. | — |
Countries
Denmark, United States
Contacts
Public ContactSøren Nielsen
Action Pharma A/S
Outcome results
None listed