In short
Ilofotase Alfa is being studied in clinical trials for different patient groups, including people at risk of kidney damage after open heart surgery and adults with hypophosphatasia. These trials are looking at safety, biological effects, and whether the treatment can improve key health measures.
Key points
- Clinical trials of Ilofotase Alfa in the source data focus on two different groups: people at risk for kidney damage after open heart surgery and adults with hypophosphatasia. One study was Phase 2 and tested whether Ilofotase Alfa could help protect kidney function after surgery. The other was a small Phase 1 pilot trial that looked at changes in blood markers in adults with hypophosphatasia. Both trials were interventional and both are completed. The main outcomes were serum creatinine for kidney function and PPi/PLP levels for the hypophosphatasia study.
Clinical trials overview
The source data includes two interventional studies, which means researchers gave Ilofotase Alfa to study its effects in people. Both trials are listed as completed. One study was in people at risk for kidney damage after open heart surgery, and the other was in adults with hypophosphatasia.
Trial in kidney damage after cardiac surgery
NCT06168799 studied Ilofotase Alfa for the prevention of renal damage after cardiac surgery, especially after open heart surgery. The trial included 250 people and was a Phase 2 study. Phase 2 studies usually look more closely at whether a treatment may help a specific problem in a larger group than early-stage trials.
The brief summary says the study aimed to assess the effect of Ilofotase Alfa on renal function, which means how well the kidneys work. The study compared Ilofotase Alfa with a placebo, which is a look-alike product with no active study drug.
Pilot trial in hypophosphatasia
The second study, 2023-503186-35-00, was a Phase 1 pilot trial in adults with hypophosphatasia. It included 12 participants and tested a single dose of Ilofotase Alfa given by intravenous use, meaning through a vein.
This early study looked at the effect of a low or high dose on the biochemical profile in adult HPP patients. In simple terms, the researchers were checking how the treatment changed certain lab markers in the blood.
What the trials measured
The cardiac surgery trial used the ratio between the highest serum creatinine value after surgery and the baseline value before surgery as its primary outcome. Serum creatinine is a blood test that helps show kidney function.
The hypophosphatasia trial measured changes in inorganic pyrophosphate (PPi) and pyridoxal 5’-phosphate (PLP) after low and high doses of Ilofotase Alfa. These were used to see whether the treatment changed important lab values in adults with HPP.
Study design and participation
Both studies were interventional, so the research team actively gave the study treatment rather than only observing people. The cardiac surgery study used a placebo comparison, while the hypophosphatasia study focused on a single-dose pilot design.
Based on the source data, participation was limited to people with the specific conditions being studied: risk for renal damage after open heart surgery in one trial, and adult hypophosphatasia in the other. The data does not provide more detailed eligibility rules such as age cutoffs, lab limits, or other medical requirements.