Nephro Trial Files: Veverimer vs. Placebo in CKD and Metabolic Acidosis, Sparsentan vs. Irbesartanin IgA Nephropathy, and Hypertension Treatment During Pregnancy
VALOR-CKD: A Multicenter, Randomized, Double-Blind Placebo-Controlled Trial Evaluating Veverimer in Slowing Progression of CKD in Patients with Metabolic Acidosis
Tangri N et al. JASN (January 2024)
Bottom Line: This is a Phase 3, double-blind, placebo-controlled trial with a duration of 24 months. The study aimed to determine if treatment with veverimer, a hydrochloric acid binder, could slow chronic kidney disease (CKD) progression in patients with CKD and metabolic acidosis. The study included 1480 participants from 35 countries who were randomized to receive either veverimer or placebo. The primary outcome was the composite endpoint of CKD progression, which was not significantly different between the two groups. The study found no significant difference in safety outcomes between the groups. In conclusion, treatment with veverimer did not slow CKD progression in this patient population.
Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT)
Rovin BH et al. The Lancet (December 2023)
Bottom Line: This is a phase 3, double-blind, randomized, active-controlled study that lasted for 110 weeks. The study included 404 patients aged 18 years or older with biopsy-proven primary IgA nephropathy and proteinuria of at least 1·0 g per day. The patients were randomly assigned to receive either sparsentan (target dose 400 mg oral sparsentan once daily) or irbesartan (target dose 300 mg oral irbesartan once daily). The primary outcome was the change in proteinuria between the two treatment groups at 36 weeks. The results showed that sparsentan significantly reduced proteinuria compared to irbesartan and this reduction was maintained throughout the study period. Additionally, patients in the sparsentan group had a slower rate of decline in kidney function compared to those in the irbesartan group. The study also showed that sparsentan was well-tolerated with no new safety signals. In conclusion, treatment with sparsentan resulted in significant reductions in proteinuria and preservation of kidney function in patients with IgA nephropathy over 110 weeks.
Treatment for Mild Chronic Hypertension during Pregnancy
Tita AT et al. NEJM (May 2022)
Bottom Line: This open-label, multicenter, randomized trial included 2408 pregnant women with mild chronic hypertension and singleton fetuses at a gestational age of less than 23 weeks. The participants were randomly assigned to receive antihypertensive medications recommended for use in pregnancy (active-treatment group) or to receive no such treatment unless severe hypertension (systolic pressure, ≥160 mm Hg; or diastolic pressure, ≥105 mm Hg) developed (control group). The primary outcome was a composite of preeclampsia with severe features, medically indicated preterm birth at less than 35 weeks' gestation, placental abruption, or fetal or neonatal death. The safety outcome was small-for-gestational-age birth weight below the 10th percentile for gestational age. The results showed that the incidence of a primary-outcome event was lower in the active-treatment group than in the control group (30.2% vs. 37.0%), with no increase in the risk of small-for-gestational-age birth weight. Hence, targeting a blood pressure of less than 140/90 mm Hg was associated with better pregnancy outcomes than a strategy of reserving treatment only for severe hypertension.
Nephro Trial Files Issue #NPH-2024-04
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