In short
Carperitide is a protein-based investigational substance also known as human atrial natriuretic peptide (hANP). It is being studied in a Phase 2 trial to prevent acute kidney injury (AKI) in newborns and infants up to 12 months old after cardiac surgery with cardiopulmonary bypass. The trial plans to enroll 100 participants and is currently authorised but not yet recruiting.
Carperitide, also known as human atrial natriuretic peptide (hANP), is a protein-based substance of natural origin. It is an investigational substance with no marketing authorisation in the product records, supplied by Vaestra Goetalandsregionen under the product name HANP injection 1000. It is classified in the therapeutic area of analytical, diagnostic and therapeutic techniques and equipment.
Key points
- Carperitide is a protein-based investigational substance, also called human atrial natriuretic peptide (hANP).
- It is being tested in a Phase 2 trial for preventing acute kidney injury (AKI) after cardiac surgery.
- The study population is newborns and infants aged 0–12 months undergoing heart surgery with cardiopulmonary bypass.
- The planned enrollment is 100 participants, and the trial is currently authorised but not yet recruiting.
- The main measure is the change in creatinine clearance from baseline to 5 hours after starting the infusion.
- Carperitide is given as a powder for infusion administered by intravenous infusion.
What is carperitide?
Carperitide is a protein-based substance that corresponds to the human atrial natriuretic peptide (hANP), a naturally occurring peptide of 28 amino acids. It is also known by synonyms such as atrial natriuretic peptide (human, 1-28), SUN 4936, and carperitide [INN]. In the clinical trial record, the product is named HANP injection 1000. Carperitide has no marketing authorisation in the product records and is therefore an investigational substance.
How does carperitide work?
Carperitide is the human atrial natriuretic peptide, a hormone produced by the heart that promotes sodium and water excretion by the kidneys and relaxes blood vessels. In the trial, the substance is being evaluated for its potential to improve renal function after cardiac surgery by measuring the change in creatinine clearance, a marker of how well the kidneys filter blood. The primary endpoint is the change in measured creatinine clearance from baseline to 5 hours after the start of the infusion, used as a sensitive surrogate for glomerular filtration rate (GFR).
Which conditions is carperitide studied for?
- Acute kidney injury (AKI) after cardiac surgery in newborns and infants — the trial targets early postoperative renal dysfunction and fluid imbalance in children aged 0–12 months undergoing cardiac surgery with cardiopulmonary bypass.
How is carperitide given?
Carperitide is formulated as a powder for infusion and is administered by intravenous infusion. In the trial, the intervention is described as HANP injection 1000 at a dose of 72 micrograms per kilogram given by intravenous infusion.
What do the clinical trials show?
One trial of carperitide is listed in the EU Clinical Trials Information System. It is a Phase 2, interventional, randomised controlled trial with an open-label extension, currently authorised but not yet recruiting. The trial plans to enroll 100 participants: neonates under 1 month and infants aged 1–12 months undergoing cardiac surgery. The primary objective is to evaluate whether hANP, compared with placebo, improves renal function measured as the change in creatinine clearance within 5 hours after initiation of treatment. The primary endpoint is the change in measured creatinine clearance from baseline (T0) to 5 hours after the start of the infusion (T1), calculated using concurrent timed urine collection and plasma creatinine measurements. The trial is a two-part randomised controlled trial with an open-label extension.
What side effects are known?
The provided sources do not report side effects of carperitide. The FDA UNII record states that UNII availability does not imply any regulatory review or approval, and no safety data are given in the trial record.