Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery

Phase 2 Completed 271 enrolled AM-Pharma FGK Clinical Research GmbH · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The aim of this clinical trial is to evaluate the efficacy and safety of two intravenous administrations of ilofotase alfa in patients at risk for renal damage following open heart surgery.

Timeline

Start: 2023-12-19
Primary completion: 2025-10-05
Completion: 2025-12-03

Publications

Tellez Garcia JM, Steenvoorden T, Bemelman F, Hilhorst M, Tammaro A, Vogt L. Purinoreceptor P2X7 in Extracellular ATP-Mediated Inflammation through the Spectrum of Kidney Diseases and Kidney Transplantation. J Am Soc Nephrol. 2025 Mar 28;36(9):1823-1843. doi: 10.1681/ASN.0000000711.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ilofotase Alfa	Protein / enzyme biologic	128 mg	Intravenous

Indications

No indication recorded.