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Prevention of acute kidney injury after cardiac surgery in infants and neonates using carperitide (HANP injection 1000) – randomized controlled trial

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on infants from birth to 12 months who develop Acute kidney injury after undergoing cardiac surgery. The investigational treatment is an intravenous infusion of a medicine called hANP, which contains the active substance CARPERITIDE. Participants will receive either the study drug or a placebo shortly after the operation.

The purpose of the study is to determine whether the drug can improve kidney function compared with placebo. Kidney function will be assessed by measuring how well the kidneys filter waste, using a test called creatinine clearance, during the first few hours after the infusion starts.

After the surgery, eligible infants are randomly assigned to receive the study medication or placebo. The infusion is given over a short period, and blood and urine samples are collected for safety checks and to evaluate kidney performance. The children are then observed for about two days to monitor urine output, fluid balance, and any signs of kidney problems, with follow‑up continuing until the study ends.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization and group assignment
After enrollment you are assigned by a computer system to receive either hanp injection 1000 (the study drug) or a matching placebo. the assignment is concealed from you and the clinical team until the infusion is prepared.
Step 2
Baseline kidney function assessment
A blood sample is taken to measure creatinine, a waste product that indicates how well the kidneys are filtering. the level is used to calculate creatinine clearance, which estimates kidney filtration rate.
A timed urine collection is started to measure the amount of urine produced per kilogram of body weight per hour. this information is combined with the blood test to determine baseline kidney function before any study medication is given.
Step 3
Administration of study medication
The study drug, hanp injection 1000, contains the active substance carperitide. it is given as an intravenous infusion at a dose of 72 µg per kilogram of body weight.
The infusion is prepared by the pharmacy and delivered through a vein. it is administered as a single dose, typically over a short period as directed by the study protocol.
Step 4
Early post‑infusion monitoring (first 5 hours)
Blood is drawn again 5 hours after the start of the infusion to repeat the creatinine measurement.
The new creatinine value is used to calculate the change in creatinine clearance from the baseline value. this change is the primary outcome used to evaluate the effect of the study drug on kidney function.
Step 5
Post‑operative observation for 48 hours
Urine output continues to be measured each hour and recorded as milliliters per kilogram per hour.
The total amount of fluid given and lost is tracked to calculate cumulative fluid balance and the percentage of fluid overload.
Additional blood and urine samples may be taken to assess kidney injury markers such as ngal, kim‑1, and cystatin c, which provide further information about kidney health.
Step 6
Final assessment on postoperative day 2
At 48 hours after surgery (postoperative day 2) the incidence and severity of acute kidney injury are evaluated using standard criteria (pRIFLE and KDIGO).
The data collected during the first 48 hours, including urine output, fluid balance, and kidney biomarkers, are compiled for analysis.

Who can join the trial?

6 criteria

Written informed consent from both legal guardians must be obtained (or a delayed consent allowed in urgent situations approved by the Ethics Committee). This means parents or legal caregivers have signed a permission form after receiving all study information.
The child’s age must fit the study: infants aged 1‑12 months need to be at least 28 days old and have a postmenstrual age of 42 weeks or more; newborns younger than 1 month must have a postmenstrual age between 34 and about 46 weeks. Postmenstrual age is the total number of weeks since the mother’s last menstrual period, used to gauge developmental maturity.
The baby must be scheduled for cardiac surgery that uses a heart‑lung machine called cardiopulmonary bypass and then be admitted to the PICU (pediatric intensive care unit) after the operation. Cardiopulmonary bypass temporarily takes over the function of the heart and lungs during surgery; PICU is a specialized unit for seriously ill children.
On the first morning after surgery, the baby must show a risk of kidney injury, defined as either a drop of at least 25% in the estimated creatinine clearance (eCrCl) (a test that measures how well the kidneys filter waste) or having more than 10% extra fluid in the body (fluid overload). Fluid overload means the body is retaining too much fluid.
The child must be expected to be taken off the heart‑lung machine (weaning from CPB) before 7 p.m. on the day of surgery. Weaning from CPB means stopping the use of the machine.
The baby must have already received at least one dose of a loop diuretic (furosemide), a medication that helps the body get rid of extra water.

Who cannot join the trial?

7 criteria

You have a known allergy (hypersensitivity) to the study drug hANP or to any of the inactive ingredients (excipients) that are mixed with it.
You have severe liver problems (severe hepatic dysfunction) that the doctor considers significant.
You need kidney support treatment such as dialysis (renal replacement therapy) after surgery at the time you would be enrolled.
You are already on, or are expected to need, a heart‑lung machine that takes over the work of the heart and lungs (ECMO) before or after surgery when you would be enrolled.
You have already received the study drug hANP before surgery or within the first day after surgery (before post‑operative day 1 (POD1)).
You have taken part in another experimental treatment study in the past 30 days, and that treatment might interfere with this study’s drug, safety, or results (interventional clinical study).
You were admitted to the hospital less than 6 hours before your surgery, meaning there was not enough time to stabilize you before the operation (ultra‑acute clinical presentation).

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Verified sites

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Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
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Gothenburg, Sweden

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Investigated drugs

HANP injection 1000 is a medication that contains a synthetic form of a natural hormone called atrial natriuretic peptide. This hormone helps the kidneys filter waste, promotes the removal of extra fluid and salt, and can improve blood flow to the kidneys. In the trial, the drug is given by intravenous infusion shortly after children undergo heart surgery to see if it can protect the kidneys and lower the risk of acute kidney injury. Researchers will compare kidney function in children who receive this medication with those who receive a placebo.

What is already known about the treatment

Carperitide - Carperitide is given as a powder that is mixed and infused intravenously, usually as a continuous drip. It is an approved drug in Japan for heart failure and is studied in many research papers, but it is not widely used elsewhere yet. It is used to protect kidneys and improve fluid balance after heart surgery in newborns and infants. Carperitide works by acting like the natural hormone atrial natriuretic peptide, relaxing blood vessels and helping the kidneys remove salt and water; it belongs to the class of natriuretic peptide preparations.

Investigated diseases

Acute kidney injury - A sudden reduction in the kidneys' ability to filter waste and excess fluid from the blood. It often appears within hours after a stressful event such as heart surgery that uses a heart‑lung machine. The condition can cause a buildup of waste products, leading to changes in urine amount and composition. As the injury progresses, the kidneys may become less efficient at maintaining fluid and electrolyte balance. This decline can continue over the first few days after surgery if the underlying cause is not resolved.