Nephro Trial Files: Atrasentan in IgA Nephropathy, Mizoribine vs. Cyclophosphamide in Lupus Nephritis, and Home BP Lowering in CKD
Atrasentan in Patients with IgA Nephropathy
Heerspink HJL et al. NEJM (October 2024)
Bottom Line: This phase 3, double-blind, randomized controlled trial evaluated the efficacy and safety of atrasentan in reducing proteinuria in adults with biopsy-proven IgA nephropathy. A total of 340 patients were randomly assigned to receive either atrasentan or placebo for 132 weeks. The primary outcome was the change in 24-hour urinary protein-to-creatinine ratio from baseline to week 36, which showed a significant reduction in the atrasentan group compared to placebo. Safety analyses showed no significant differences in adverse events between the two groups. In conclusion, atrasentan showed efficacy in reducing proteinuria in patients with IgA nephropathy without any significant safety concerns.
Mizoribine or Cyclophosphamide for Lupus Nephritis
Dong Z et al. JAMA Network Open (March 2025)
Bottom Line: This was a phase 3, open-label, randomized controlled trial conducted at 40 centers in China from 2014 to 2019, evaluating oral mizoribine versus intravenous cyclophosphamide for induction therapy in 243 patients with class III, III+V, IV, IV+V, or V lupus nephritis. Patients were randomized to receive mizoribine (n = 123) or cyclophosphamide (n = 120) plus glucocorticoids for 52 weeks. The primary outcome, total remission rate at 52 weeks, was 66.1% in the mizoribine group and 76.8% in the cyclophosphamide group (RR, 0.861; 95% CI, 0.729–1.016), meeting noninferiority criteria. Immune parameters and kidney function changes were similar between groups. Treatment-related adverse events occurred in 80.5% of mizoribine-treated patients and 78.7% of cyclophosphamide-treated patients, with upper respiratory infections being most common. The study concluded that mizoribine is noninferior to cyclophosphamide and is a viable alternative for lupus nephritis induction therapy.
Intensive Home Blood Pressure Lowering in Patients With Advanced CKD
Ku E et al. American Journal of Kidney Diseases (March 2025)
Bottom Line: This was a nonblinded, randomized controlled pilot trial evaluating intensive versus less intensive systolic blood pressure (SBP) targets in 108 patients with advanced chronic kidney disease (CKD) and hypertension. Participants were randomized to an SBP target of <120 mm Hg (n = 66) or a less intensive target (n = 42), with antihypertensive medications titrated based on real-time home BP monitoring over 12 months. At month 12, mean clinic SBP was 124.7 mm Hg in the intensive group versus 138.2 mm Hg in the less intensive group, with a mean difference of 11.7 mm Hg (95% CI, 7.5–16; P<0.001). Safety outcomes, including hyperkalemia, falls, syncope, and need for dialysis or transplantation, were not significantly different between groups. The study concluded that intensive BP control using home monitoring is feasible and appears safe in advanced CKD, warranting larger trials to confirm optimal BP targets.
Nephro Trial Files Issue #NPH-2025-06
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