Nephro Trial Files: CM Diversion System for AKI Prevention in ACS, Atacicept for IgA Nephropathy, and Fesomersen for Patients with Kidney Failure on Hemodialysis
Kidney Injury After Minimal Radiographic Contrast Administration in Patients With Acute Coronary Syndromes
Briguori C et al. JACC (March 2024)
Bottom Line: This randomized, single-blind, investigator-driven clinical trial evaluated the effectiveness of the DyeVert CM diversion system in reducing contrast media (CM) volume and preventing acute kidney injury (AKI) in patients with acute coronary syndromes (ACS) undergoing invasive procedures. The study included 550 participants and compared the intervention group, which used the CM diversion system, to the control group, which used conventional methods. Results showed a significant reduction in AKI in the intervention group (16%) compared to the control group (24.3%). The study concluded that the use of the CM diversion system was effective in reducing CM volume and preventing AKI in this patient population.
A Phase 2b, randomized, double-blind, placebo-controlled, clinical trial of atacicept for treatment of IgA nephropathy
Lafayette R et al. Kidney International (March 2024)
Bottom Line: This phase 2b clinical trial evaluated the efficacy and safety of atacicept, a first-in-class dual anti-B-cell Activation Factor-A Proliferation-Inducing Ligand fusion protein, in patients with IgA nephropathy. The study enrolled 116 individuals and randomized them to receive atacicept or placebo once weekly for up to 36 weeks. The primary endpoint, a reduction in urine protein creatinine ratio, was met at week 24 with a 25% reduction in the atacicept group compared to placebo. At week 36, the key secondary endpoint, a reduction in proteinuria, was also met with a 35% reduction in the atacicept group compared to placebo. The safety profile of atacicept was similar to placebo. These results support further investigation of atacicept in a phase 3 study for the treatment of IgA nephropathy.
A Phase II randomized controlled trial evaluated antithrombotic treatment with fesomersen in patients with kidney failure on hemodialysis
Winkelmayer WC et al. Kidney International (March 2024)
Bottom Line: This Phase IIb study evaluated the efficacy and safety of fesomersen, an inhibitor of hepatic Factor XI expression, in patients with kidney failure on hemodialysis (KF-HD). The study included 308 participants who were randomized to receive fesomersen (40, 80, or 120 mg once-monthly) or placebo for up to 12 months. The primary outcome was a reduction in steady-state median FXI levels, which was achieved in a dose-dependent and sustained manner with fesomersen. Safety outcomes showed similar rates of major bleeding between fesomersen and placebo groups. In conclusion, fesomersen was found to be effective in reducing FXI levels without increasing the risk of major bleeding in patients with KF-HD.
Nephro Trial Files Issue #NPH-2024-08
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