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Kidney Week

Abstract: INFO06-SA

A Multi-Center Study to Evaluate the Safety, Tolerability, and Efficacy of TIN816 in Patients at Risk for AKI Following Cardiac Surgery

Session Information

  • Informational Posters - III
    November 04, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Acute Kidney Injury

  • No subcategory defined

Authors

  • Demirci, Gulcin, Novartis Institutes for BioMedical Research Basel, Basel, Basel-Stadt, Switzerland
  • Panchaud, Nicolas, Novartis Institutes for BioMedical Research Basel, Basel, Basel-Stadt, Switzerland
  • Biondani, Andrea, Novartis Institutes for BioMedical Research Basel, Basel, Basel-Stadt, Switzerland
  • Nidamarthy, Prasanna Kumar, Novartis Healthcare Pvt. Ltd., Hyderabad, India
  • Warncke, Max, Novartis Institutes for BioMedical Research Basel, Basel, Basel-Stadt, Switzerland
  • Junge, Guido, Novartis Institutes for BioMedical Research Basel, Basel, Basel-Stadt, Switzerland
Description

Acute injury kidney (AKI) is a frequent and serious complication after major cardiac surgery, however current options to prevent or treat AKI remain ineffective and limited to supportive care. CTIN816A12201 (CTG-ID: NCT05524051) is a non-confirmatory, randomized, placebo-controlled, participant and investigator-blinded Ph2 study to evaluate the safety, tolerability and efficacy of TIN816 in adult patients at risk for acute kidney injury following cardiac surgery. TIN16 is a recombinant human CD39 enzyme.
The study will enroll approximately 120 participants scheduled for non-emergent open chest cavity major cardiopulmonary bypass (CPB) surgery with expected CPB time ≥ 60 minutes. The study consists of a screening period (up to 30 days), a treatment period (day 1) where patients receive a single IV dose of TIN816 or placebo at a 1:1 ratio, and a post-treatment period (days 2 to 90).
Key inclusion criteria include age ≥ 45 years and age-adapted eGFR ≤ 60 mL/min/1.73m2, while key exclusion criteria are eGFR <15 mL/min/1.73m2, renal replacement therapy, labs or medical history indicative of a bleeding risk. The primary objective of the study is to assess the effect of TIN816 on kidney function, with a primary endpoint of the ratio of highest serum creatinine (SCr) vs baseline within 5 days post-dose. Secondary objectives of the study include safety and tolerability of TIN816, the effect of TIN816 on incidence and severity of AKI, and the effect of TIN816 on acute kidney disease (AKD) as assessed by major adverse kidney effects on day 30 and day 90 post-surgery (MAKE30 and MAKE90). The study is currently enrolling and started in March 2023, with completion expected in October 2024.