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Ilofotase Alfa

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.

Table of Contents

Clinical trials overview

The source data includes two interventional studies, which means researchers gave Ilofotase Alfa to study its effects in people.[1][2] Both trials are listed as completed.[1][2] One study was in people at risk for kidney damage after open heart surgery, and the other was in adults with hypophosphatasia.[1][2]

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.[1] The trial included 250 people and was a Phase 2 study.[1] 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.[1] The study compared Ilofotase Alfa with a placebo, which is a look-alike product with no active study drug.[1]

Pilot trial in hypophosphatasia

The second study, 2023-503186-35-00, was a Phase 1 pilot trial in adults with hypophosphatasia.[2] It included 12 participants and tested a single dose of Ilofotase Alfa given by intravenous use, meaning through a vein.[2]

This early study looked at the effect of a low or high dose on the biochemical profile in adult HPP patients.[2] In simple terms, the researchers were checking how the treatment changed certain lab markers in the blood.[2]

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.[1] Serum creatinine is a blood test that helps show kidney function.[1]

The hypophosphatasia trial measured changes in inorganic pyrophosphate (PPi) and pyridoxal 5’-phosphate (PLP) after low and high doses of Ilofotase Alfa.[2] These were used to see whether the treatment changed important lab values in adults with HPP.[2]

Study design and participation

Both studies were interventional, so the research team actively gave the study treatment rather than only observing people.[1][2] The cardiac surgery study used a placebo comparison, while the hypophosphatasia study focused on a single-dose pilot design.[1][2]

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.[1][2] The data does not provide more detailed eligibility rules such as age cutoffs, lab limits, or other medical requirements.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT06168799 Phase 2 Risk for renal damage following open heart surgery Completed 250
2023-503186-35-00 Phase 1 Hypophosphatasia Completed 12

FAQ

  • What clinical trials of Ilofotase Alfa are included here? The data includes two completed interventional trials. One studied prevention of renal damage after cardiac surgery, and the other was a pilot study in adults with hypophosphatasia.
  • Who could take part in these trials? One trial included people at risk for renal damage after open heart surgery. The other trial included adult patients with hypophosphatasia.
  • What phases were the Ilofotase Alfa trials? One study was Phase 2 and the other was Phase 1. Phase 1 studies usually focus on early testing, while Phase 2 studies look more closely at whether the treatment may help.
  • What was being measured in the trials? The cardiac surgery trial measured serum creatinine, a blood test used to check kidney function. The hypophosphatasia trial measured changes in inorganic pyrophosphate and pyridoxal 5’-phosphate levels.
  • Are these Ilofotase Alfa trials still recruiting? No. Both trials listed in the data are completed.

Ongoing Clinical Trials on Ilofotase Alfa

  • Study of ilofotase alfa effects on biomarkers in adults with hypophosphatasia

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Ilofotase Alfa to Prevent Kidney Damage in Patients Undergoing Open Heart Surgery

    Not recruiting

    1
    Investigated drugs:
    Belgium Germany The Netherlands

Glossary

  • Interventional study: A study where researchers give a treatment or compare treatments to see what happens.
  • Phase 1: An early trial phase that usually checks how a treatment affects the body and looks at basic safety and biological effects.
  • Phase 2: A trial phase that looks more closely at whether a treatment may help a specific condition.
  • Open heart surgery: A major operation on the heart that is done through the chest.
  • Renal damage: Injury or harm to the kidneys.
  • Serum creatinine: A blood test used to help check how well the kidneys are working.
  • Hypophosphatasia: A rare condition studied in the trial; the source data does not give a full description of the disease.
  • Biochemical profile: A group of lab measurements that show how certain body chemicals are changing.
  • Inorganic pyrophosphate (PPi): A substance measured in the blood in the hypophosphatasia trial.
  • Pyridoxal 5’-phosphate (PLP): A form of vitamin B6 measured in the hypophosphatasia trial.

References