Evaluation of hANP for prevention of acute kidney injury after cardiac surgery: A two-part randomized controlled trial with open-label extension in children aged 0–12 months.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Vaestra Goetalandsregionen

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Decision date (initial)

2026-05-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Therapy, Safety, Pharmacodynamic

The primary objective of this trial is to evaluate whether hANP, compared with placebo, improves renal function in neonates (<1 month) and infants (1–12 months) undergoing cardiac surgery, measured as the change in creatinine clearance (CrCl) within 5 hours after initiation of treatment (T0–T1).

Secondary objectives 5

1. To assess whether hANP reduces the incidence and severity of AKI within 48 hours after surgery, using pRIFLE and KDIGO criteria.
2. To evaluate the effect of hANP on urine output, cumulative fluid balance, and degree of fluid overload during the first 48 postoperative hours.
3. To explore changes in renal biomarkers (e.g., NGAL, KIM-1, cystatin C and others) and functional indices related to kidney injury and repair.
4. To compare renal outcomes between hANP- and placebo-treated groups in relation to cardiopulmonary bypass duration and other predefined subgroups.
5. To compare the incidence of AKI in the hANP cohort with that of an external matched reference cohort from another Nordic center.

Conditions and MedDRA coding

Acute kidney injury (AKI) occurring in newborns and infants after cardiac surgery with cardiopulmonary bypass. The study targets early postoperative renal dysfunction and fluid imbalance in this high-risk population.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Written informed consent from both legal guardians has been obtained (or deferred consent in urgent cases, as approved by the Ethics Committee).
2. 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.
3. Scheduled for cardiac surgery with cardiopulmonary bypass and postoperative admission to the PICU.
4. On the first postoperative morning, meets risk of AKI defined as either: a. ≥25% decline in estimated creatinine clearance (eCrCl) (pRIFLE “Risk” or worse), or b. Fluid overload >10%.
5. Weaning from CPB expected before 19:00 on the operation day.
6. Patient has received at least one postoperative dose of loop diuretic (furosemide).

Exclusion criteria 7

1. Known hypersensitivity to hANP or any excipients in the investigational product.
2. Severe hepatic dysfunction (clinically significant hepatic impairment judged by the investigator).
3. Need for renal replacement therapy (RRT) postoperatively at the time of inclusion.
4. Preoperative ECMO treatment or anticipated/required postoperative ECMO at the time of inclusion.
5. Treatment with hANP preoperatively or postoperatively before POD1.
6. 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.
7. Admission to hospital less than 6 hours prior to start of surgery, indicating an ultra-acute clinical presentation without sufficient time for preoperative stabilization.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 7

1. Incidence and severity of AKI at 48 hours post-surgery (POD2), defined according pRIFLE and KDIGO criteria.
2. Urine output (mL/kg/h) during the first 48 postoperative hours.
3. Cumulative fluid balance and percentage fluid overload (%FO) during the first 48 postoperative hours.
4. 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).
5. Cl-urea and temporal trends in CrCl and Cl-urea at predefined time points (T0, T1, T2).
6. Subgroup comparisons of renal outcomes stratified by cardiopulmonary bypass duration and other predefined subgroups.
7. Comparison of AKI incidence at POD2 with an external matched reference cohort from another Nordic center.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vaestra Goetalandsregionen

Sponsor organisation

Vaestra Goetalandsregionen

Address

Regionens Hus

City

Vaenersborg

Postcode

462 80

Country

Sweden

Scientific contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Albert Gyllencreutz Castellheim

Public contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Albert Gyllencreutz Castellheim

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications