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Kidney Week

Abstract: TH-PO1195

SPARKLE: A Multicenter, Open-Label Study to Evaluate the Safety and Diagnostic Efficacy of ACE-MBCA in Patients with Known or Suspected Focal Liver Lesions and Severe Renal Impairment

Session Information

Category: Diversity and Equity in Kidney Health

  • 900 Diversity and Equity in Kidney Health

Authors

  • Croci Chiocchini, Anna Laura, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola, Bologna, Emilia-Romagna, Italy
  • Norlin, Andreas L, Ascelia Pharma AB, Malmo, Sweden
  • Hettiarachchige, Nadilka, Ascelia Pharma AB, Malmo, Sweden
  • Ortiz Melo, David I., Duke University, Durham, North Carolina, United States
Background

ACE-MBCA (Ascelia Pharma Manganese Based Contrast Agent, proposed trade name Orviglance) is an oral manganese-based liver-specific MRI contrast agent. Over 35 million Americans have renal disease,those severely affected at higher risk of safety concerns associated with Gadolinium Based Contrast Agents (GBCAs). This phase 3 study evaluates the safety and efficacy of ACE-MBCA in patients with focal liver lesions and severe renal impairment, a group for which the FDA has issued a black-box warning for all GBCAs due to the kidneys' reduced ability to remove the GBCAs from the bloodstream.The study uniquely includes patients with severe kidney disease, often excluded due to high safety risks, addressing a critical gap in imaging research and providing insights into the safety and efficacy of ACE-MBCA for liver MR contrast agent alternatives.

Methods

In this global phase III study, patients (N=85) with known or suspected focal liver lesions and severe renal impairment received a liver MRI before and 4±1 h after the administration of ACE-MBCA (800 mg). The primary analysis, improvement in visualization of focal lesions, was evaluated by 3 independent readers by qualitative scoring of the change in two co-primary variables, lesion contrast (LC) and border delineation (BD) (scores from 1= poor to 4= excellent). Safety follow-ups, at 24 (± 4) h, 48 (± 4) h, and 5 (± 2) days post-dose.

Results

In 85 patients, the primary analysis showed highly significant (p<0.001) improvement of the mean LC and BD scores in combined MRI (CMRI: combined contrast-enhanced + unenhanced MRI) compared to unenhanced MRI: Across the 3 readers, the mean (SD) LC increased by between 0.65 (0.622) and 0.95 (0.824) score points and mean (SD) BD was increased by between 0.81 (0.678) and 1.02 (0.909) score points. No patients were withdrawn from the study. The most reported post-dose AEs were mild to moderate nausea (16.1%), diarrhea (13.8%), vomiting (9.2%), and blood urea increased (3.4%). No drug-related serious AE or deaths were reported.

Conclusion

ACE-MBCA 800 mg significantly improves diagnostic efficacy over unenhanced MR, offering a promising future diagnostic tool for kidney-impaired patients who currently lack safer options for contrast-enhanced liver MRI.

Funding

  • Commercial Support – Ascelia Pharma AB