CARPERITIDE for Acute kidney injury

Inclusion criteria

• {"criterion_text":"- Written informed consent from both legal guardians has been obtained (or deferred consent in urgent cases, as approved by the Ethics Committee).\n- Infants (1–12 months): Chronological age 28 days to 12 months and postmenstrual age ≥42+0 weeks at time of inclusion. Neonates (<1 month): Postmenstrual age between 34+0 and 45+6 weeks at time of inclusion.\n- Scheduled for cardiac surgery with cardiopulmonary bypass and postoperative admission to the PICU.\n- On the first postoperative morning, meets risk of AKI defined as either: a.\t≥25% decline in estimated creatinine clearance (eCrCl) (pRIFLE “Risk” or worse), or b.\tFluid overload >10%.\n- Weaning from CPB expected before 19:00 on the operation day.\n- Patient has received at least one postoperative dose of loop diuretic (furosemide)."}

Exclusion criteria

• {"criterion_text":"- Known hypersensitivity to hANP or any excipients in the investigational product.\n- Severe hepatic dysfunction (clinically significant hepatic impairment judged by the investigator).\n- Need for renal replacement therapy (RRT) postoperatively at the time of inclusion.\n- Preoperative ECMO treatment or anticipated/required postoperative ECMO at the time of inclusion.\n- Treatment with hANP preoperatively or postoperatively before POD1.\n- Participation in another interventional clinical study within the last 30 days, if the intervention may, in the opinion of the investigator, interfere with study treatment, safety, or outcome assessment.\n- Admission to hospital less than 6 hours prior to start of surgery, indicating an ultra-acute clinical presentation without sufficient time for preoperative stabilization."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of this trial is the change in measured creatinine clearance (CrCl) from baseline (T0) to 5 hours after start of the investigational product infusion (T1). CrCl will be calculated using concurrent timed urine collection and plasma creatinine measurements. This endpoint is chosen as a sensitive surrogate for GFR and reflects short-term renal functional response to the intervention.","definition_or_measurement_approach":"CrCl will be calculated using concurrent timed urine collection and plasma creatinine measurements; change measured from baseline (T0) to 5 hours after infusion start (T1)."}

Secondary endpoints

• {"endpoint_text":"- Incidence and severity of AKI at 48 hours post-surgery (POD2), defined according pRIFLE and KDIGO criteria.","definition_or_measurement_approach":"AKI incidence and severity assessed at 48 hours post-surgery using pRIFLE and KDIGO criteria."}
• {"endpoint_text":"- Urine output (mL/kg/h) during the first 48 postoperative hours.","definition_or_measurement_approach":"Urine output measured in mL/kg/h over the first 48 postoperative hours."}
• {"endpoint_text":"- Cumulative fluid balance and percentage fluid overload (%FO) during the first 48 postoperative hours.","definition_or_measurement_approach":"Cumulative fluid balance and % fluid overload calculated over first 48 postoperative hours."}
• {"endpoint_text":"- Changes in renal biomarkers and indices related to kidney injury and repair (e.g., NGAL, KIM-1, cystatin C, and others listed in Appendix 1–2).","definition_or_measurement_approach":"Serial measurement of specified renal biomarkers (NGAL, KIM-1, cystatin C, etc.) as listed in protocol appendices."}
• {"endpoint_text":"- Cl-urea and temporal trends in CrCl and Cl-urea at predefined time points (T0, T1, T2).","definition_or_measurement_approach":"Measurement of Cl-urea and creatinine clearance at predefined time points T0, T1, T2 to assess temporal trends."}
• {"endpoint_text":"- Subgroup comparisons of renal outcomes stratified by cardiopulmonary bypass duration and other predefined subgroups.","definition_or_measurement_approach":"Comparative analyses of renal outcomes across predefined subgroups including stratification by cardiopulmonary bypass duration."}
• {"endpoint_text":"- Comparison of AKI incidence at POD2 with an external matched reference cohort from another Nordic center.","definition_or_measurement_approach":"Comparison of incidence of AKI at postoperative day 2 between trial cohort and an external matched reference cohort from another Nordic centre."}

Sweden

Earliest CTIS Part Ii Submission Date

29-04-2026

Latest Decision Or Authorization Date

11-05-2026

Processing Time Days

12

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Vaestra Goetalandsregionen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden