Consider solidifying your foundation with a single addition to RASi ± SGLT2i for appropriate patients. Add on VANRAFIA (atrasentan)1
VANRAFIA + maximally tolerated and stable RASi provided greater total reduction in 24-hour UPCR compared with maximally tolerated and stable RASi alone, with a 38% (95% CI: 32%, 44%) reduction from baseline in the treatment arm vs only 3% (95% CI: -7%, 12%) in the placebo arm.1,*,†
*LS geometric mean ratio in UPCR (sampled from a 24-hour urine collection) to baseline was reported as a percent reduction along with the respective 95% CI.1
†MMRM analysis included all observed UPCR data except for subjects with intercurrent events (eg, restricted medication use, chronic dialysis, kidney transplant). These subjects had UPCR data excluded beginning at the start date of the earliest event. The only intercurrent events observed were restricted medication use, which occurred in 3.0% and 5.2% of VANRAFIA- and placebo-treated subjects, respectively.1,2
‡Statistically significant results coming from an interim analysis for accelerated approval through 36 weeks of treatment. The study for full approval is ongoing and will be based on data from 132 weeks of treatment.1,2
§The estimate of the ratio of LS geometric mean ratio in UPCR (sampled from a 24-hour urine collection) to baseline comparing VANRAFIA with placebo was reported as a relative percent reduction along with the respective 95% CI and 2-sided P value.1
IIThe relative percent difference between VANRAFIA and placebo is equal to the ratio of the geometric mean minus 1 multiplied by 100: 100*[(0.62/0.97)-1]=-36%.1
¶Two-sided P value statistically significant at the 0.01 level.1
#Study design: ALIGN is a phase 3, global, multicenter, randomized, double-blind, placebo-controlled study assessing VANRAFIA in combination with a maximally tolerated and stable dose of RASi in IgAN.
Study population: 340 adult patients with biopsy-proven primary IgAN, urine protein ≥1 g/day, and an eGFR of ≥30 mL/min/1.73 m2 on a maximally tolerated and stable dose of RASi. An additional exploratory SGLT2i cohort of 64 patients who were also on a stable dose of an SGLT2i at baseline was enrolled. The interim efficacy analysis was based on the first 270 patients in the main cohort who reached the Week 36 visit.
Supportive care (RASi): Patients were primarily treated with a stable dose of maximally tolerated RASi therapy. In a separate exploratory cohort, 64 patients received an SGLT2i in addition to RASi therapy.1,2
†MMRM analysis included all observed UPCR data except for subjects with intercurrent events (eg, restricted medication use, chronic dialysis, kidney transplant). These subjects had UPCR data excluded beginning at the start date of the earliest event. The only intercurrent events observed were restricted medication use, which occurred in 3.0% and 5.2% of VANRAFIA- and placebo-treated subjects, respectively.1,2
‡Statistically significant results coming from an interim analysis for accelerated approval through 36 weeks of treatment. The study for full approval is ongoing and will be based on data from 132 weeks of treatment.1,2
§The estimate of the ratio of LS geometric mean ratio in UPCR (sampled from a 24-hour urine collection) to baseline comparing VANRAFIA with placebo was reported as a relative percent reduction along with the respective 95% CI and 2-sided P value.1
IIThe relative percent difference between VANRAFIA and placebo is equal to the ratio of the geometric mean minus 1 multiplied by 100: 100*[(0.62/0.97)-1]=-36%.1
¶Two-sided P value statistically significant at the 0.01 level.1
#Study design: ALIGN is a phase 3, global, multicenter, randomized, double-blind, placebo-controlled study assessing VANRAFIA in combination with a maximally tolerated and stable dose of RASi in IgAN.
Study population: 340 adult patients with biopsy-proven primary IgAN, urine protein ≥1 g/day, and an eGFR of ≥30 mL/min/1.73 m2 on a maximally tolerated and stable dose of RASi. An additional exploratory SGLT2i cohort of 64 patients who were also on a stable dose of an SGLT2i at baseline was enrolled. The interim efficacy analysis was based on the first 270 patients in the main cohort who reached the Week 36 visit.
Supportive care (RASi): Patients were primarily treated with a stable dose of maximally tolerated RASi therapy. In a separate exploratory cohort, 64 patients received an SGLT2i in addition to RASi therapy.1,2