UACR analysis in overall study population and a subset of pre-specified subgroups (PPS)
| Analysis group . | Placebo UACRc . | Fulacimstat UACRc . | LS mean ratio (90% CI) . | P-value . | ||||
|---|---|---|---|---|---|---|---|---|
| Visit 1 (mg/g)a . | Visit 6 (mg/g)a . | Rel. changea . | Visit 1 (mg/g)a . | Visit 6 (mg/g)a . | Rel. changea . | . | . | |
| Overall study population (fulacimstat = 83, placebo = 38) | 196.7 (149.6) | 250.7 (182.1) | 1.274 (86.0) | 159.0 (126.9) | 163.8 (197.3) | 1.030 (88.9) | 0.804 (0.627–1.030) | 0.1477 |
| eGFRCrea ≤60 mL/min/1.73 m2 (fulacimstat = 40, placebo = 19)b | 226.6 (186.0) | 409.2 (200.1) | 1.806 (80.4) | 142.9 (114.5) | 147.5 (147.6) | 1.032 (76.0) | 0.545 (0.393–0.754) | 0.0029 |
| eGFRCrea >60 mL/min/1.73 m2 (fulacimstat = 42, placebo = 19)b | 170.9 (118.7) | 153.6 (119.7) | 0.899 (68.4) | 177.4 (141.3) | 172.9 (248.4) | 0.975 (91.5) | 1.083 (0.769–1.524) | 0.6978 |
| High-risk group (fulacimstat = 25, placebo = 10) | 221.8 (164.6) | 413.8 (242.7) | 1.866 (73.8) | 167.9 (101.9) | 177.6 (143.0) | 1.058 (86.1) | 0.561 (0.351–0.897) | 0.0452 |
| No high-risk group (fulacimstat = 58, placebo = 28) | 188.6 (148.7) | 209.6 (156.1) | 1.112 (84.7) | 155.4 (139.3) | 158.2 (226.2) | 1.018 (91.1) | 0.910 (0.677–1.223) | 0.5984 |
| Israel (fula (fulacimstat = 24, placebo = 10) | 199.7 (151.7) | 228.9 (206.5) | 1.146 (44.3) | 145.5 (105.0) | 196.1 (223.3) | 1.348 (117.1) | 1.224 (0.717– 2.082) | 0.5274 |
| Bulgaria (fulacimstat = 17, palcebo = 11) | 142.3 (114.5) | 263.2 (255.6) | 1.849 (111.9) | 174.2 (226.4) | 145.3 (248.3) | 0.834 (80.7) | 0.453 (0.266–0.772) | 0.0178 |
| Finland (fulacimstat = 13, placebo = 6) | 339.7 (246.9) | 295.8 (231.3) | 0.871 (63.5) | 138.6 (90.7) | 116.6 (187.8) | 0.841 (70.0) | 1.070 (0.594–1.929) | 0.8422 |
| Spain (fulacimstat = 12, placebo = 5) | 207.1 (271.9) | 268.8 (158.3) | 1.298 (117.1) | 198.4 (145.4) | 214.7 (187) | 1.082 (58.8) | 0.828 (0.442–1.551) | 0.6062 |
| Analysis group . | Placebo UACRc . | Fulacimstat UACRc . | LS mean ratio (90% CI) . | P-value . | ||||
|---|---|---|---|---|---|---|---|---|
| Visit 1 (mg/g)a . | Visit 6 (mg/g)a . | Rel. changea . | Visit 1 (mg/g)a . | Visit 6 (mg/g)a . | Rel. changea . | . | . | |
| Overall study population (fulacimstat = 83, placebo = 38) | 196.7 (149.6) | 250.7 (182.1) | 1.274 (86.0) | 159.0 (126.9) | 163.8 (197.3) | 1.030 (88.9) | 0.804 (0.627–1.030) | 0.1477 |
| eGFRCrea ≤60 mL/min/1.73 m2 (fulacimstat = 40, placebo = 19)b | 226.6 (186.0) | 409.2 (200.1) | 1.806 (80.4) | 142.9 (114.5) | 147.5 (147.6) | 1.032 (76.0) | 0.545 (0.393–0.754) | 0.0029 |
| eGFRCrea >60 mL/min/1.73 m2 (fulacimstat = 42, placebo = 19)b | 170.9 (118.7) | 153.6 (119.7) | 0.899 (68.4) | 177.4 (141.3) | 172.9 (248.4) | 0.975 (91.5) | 1.083 (0.769–1.524) | 0.6978 |
| High-risk group (fulacimstat = 25, placebo = 10) | 221.8 (164.6) | 413.8 (242.7) | 1.866 (73.8) | 167.9 (101.9) | 177.6 (143.0) | 1.058 (86.1) | 0.561 (0.351–0.897) | 0.0452 |
| No high-risk group (fulacimstat = 58, placebo = 28) | 188.6 (148.7) | 209.6 (156.1) | 1.112 (84.7) | 155.4 (139.3) | 158.2 (226.2) | 1.018 (91.1) | 0.910 (0.677–1.223) | 0.5984 |
| Israel (fula (fulacimstat = 24, placebo = 10) | 199.7 (151.7) | 228.9 (206.5) | 1.146 (44.3) | 145.5 (105.0) | 196.1 (223.3) | 1.348 (117.1) | 1.224 (0.717– 2.082) | 0.5274 |
| Bulgaria (fulacimstat = 17, palcebo = 11) | 142.3 (114.5) | 263.2 (255.6) | 1.849 (111.9) | 174.2 (226.4) | 145.3 (248.3) | 0.834 (80.7) | 0.453 (0.266–0.772) | 0.0178 |
| Finland (fulacimstat = 13, placebo = 6) | 339.7 (246.9) | 295.8 (231.3) | 0.871 (63.5) | 138.6 (90.7) | 116.6 (187.8) | 0.841 (70.0) | 1.070 (0.594–1.929) | 0.8422 |
| Spain (fulacimstat = 12, placebo = 5) | 207.1 (271.9) | 268.8 (158.3) | 1.298 (117.1) | 198.4 (145.4) | 214.7 (187) | 1.082 (58.8) | 0.828 (0.442–1.551) | 0.6062 |
UACRc values are given as geometric means (geometric CV%).
One subject in the fulacimstat group did not have eGFR data at Visit 1. Subgroups for Sweden, Denmark and Italy were too small for analysis of covariance analysis and are not depicted. P-values are exploratory and not adjusted for multiple testing.
UACR analysis in overall study population and a subset of pre-specified subgroups (PPS)
| Analysis group . | Placebo UACRc . | Fulacimstat UACRc . | LS mean ratio (90% CI) . | P-value . | ||||
|---|---|---|---|---|---|---|---|---|
| Visit 1 (mg/g)a . | Visit 6 (mg/g)a . | Rel. changea . | Visit 1 (mg/g)a . | Visit 6 (mg/g)a . | Rel. changea . | . | . | |
| Overall study population (fulacimstat = 83, placebo = 38) | 196.7 (149.6) | 250.7 (182.1) | 1.274 (86.0) | 159.0 (126.9) | 163.8 (197.3) | 1.030 (88.9) | 0.804 (0.627–1.030) | 0.1477 |
| eGFRCrea ≤60 mL/min/1.73 m2 (fulacimstat = 40, placebo = 19)b | 226.6 (186.0) | 409.2 (200.1) | 1.806 (80.4) | 142.9 (114.5) | 147.5 (147.6) | 1.032 (76.0) | 0.545 (0.393–0.754) | 0.0029 |
| eGFRCrea >60 mL/min/1.73 m2 (fulacimstat = 42, placebo = 19)b | 170.9 (118.7) | 153.6 (119.7) | 0.899 (68.4) | 177.4 (141.3) | 172.9 (248.4) | 0.975 (91.5) | 1.083 (0.769–1.524) | 0.6978 |
| High-risk group (fulacimstat = 25, placebo = 10) | 221.8 (164.6) | 413.8 (242.7) | 1.866 (73.8) | 167.9 (101.9) | 177.6 (143.0) | 1.058 (86.1) | 0.561 (0.351–0.897) | 0.0452 |
| No high-risk group (fulacimstat = 58, placebo = 28) | 188.6 (148.7) | 209.6 (156.1) | 1.112 (84.7) | 155.4 (139.3) | 158.2 (226.2) | 1.018 (91.1) | 0.910 (0.677–1.223) | 0.5984 |
| Israel (fula (fulacimstat = 24, placebo = 10) | 199.7 (151.7) | 228.9 (206.5) | 1.146 (44.3) | 145.5 (105.0) | 196.1 (223.3) | 1.348 (117.1) | 1.224 (0.717– 2.082) | 0.5274 |
| Bulgaria (fulacimstat = 17, palcebo = 11) | 142.3 (114.5) | 263.2 (255.6) | 1.849 (111.9) | 174.2 (226.4) | 145.3 (248.3) | 0.834 (80.7) | 0.453 (0.266–0.772) | 0.0178 |
| Finland (fulacimstat = 13, placebo = 6) | 339.7 (246.9) | 295.8 (231.3) | 0.871 (63.5) | 138.6 (90.7) | 116.6 (187.8) | 0.841 (70.0) | 1.070 (0.594–1.929) | 0.8422 |
| Spain (fulacimstat = 12, placebo = 5) | 207.1 (271.9) | 268.8 (158.3) | 1.298 (117.1) | 198.4 (145.4) | 214.7 (187) | 1.082 (58.8) | 0.828 (0.442–1.551) | 0.6062 |
| Analysis group . | Placebo UACRc . | Fulacimstat UACRc . | LS mean ratio (90% CI) . | P-value . | ||||
|---|---|---|---|---|---|---|---|---|
| Visit 1 (mg/g)a . | Visit 6 (mg/g)a . | Rel. changea . | Visit 1 (mg/g)a . | Visit 6 (mg/g)a . | Rel. changea . | . | . | |
| Overall study population (fulacimstat = 83, placebo = 38) | 196.7 (149.6) | 250.7 (182.1) | 1.274 (86.0) | 159.0 (126.9) | 163.8 (197.3) | 1.030 (88.9) | 0.804 (0.627–1.030) | 0.1477 |
| eGFRCrea ≤60 mL/min/1.73 m2 (fulacimstat = 40, placebo = 19)b | 226.6 (186.0) | 409.2 (200.1) | 1.806 (80.4) | 142.9 (114.5) | 147.5 (147.6) | 1.032 (76.0) | 0.545 (0.393–0.754) | 0.0029 |
| eGFRCrea >60 mL/min/1.73 m2 (fulacimstat = 42, placebo = 19)b | 170.9 (118.7) | 153.6 (119.7) | 0.899 (68.4) | 177.4 (141.3) | 172.9 (248.4) | 0.975 (91.5) | 1.083 (0.769–1.524) | 0.6978 |
| High-risk group (fulacimstat = 25, placebo = 10) | 221.8 (164.6) | 413.8 (242.7) | 1.866 (73.8) | 167.9 (101.9) | 177.6 (143.0) | 1.058 (86.1) | 0.561 (0.351–0.897) | 0.0452 |
| No high-risk group (fulacimstat = 58, placebo = 28) | 188.6 (148.7) | 209.6 (156.1) | 1.112 (84.7) | 155.4 (139.3) | 158.2 (226.2) | 1.018 (91.1) | 0.910 (0.677–1.223) | 0.5984 |
| Israel (fula (fulacimstat = 24, placebo = 10) | 199.7 (151.7) | 228.9 (206.5) | 1.146 (44.3) | 145.5 (105.0) | 196.1 (223.3) | 1.348 (117.1) | 1.224 (0.717– 2.082) | 0.5274 |
| Bulgaria (fulacimstat = 17, palcebo = 11) | 142.3 (114.5) | 263.2 (255.6) | 1.849 (111.9) | 174.2 (226.4) | 145.3 (248.3) | 0.834 (80.7) | 0.453 (0.266–0.772) | 0.0178 |
| Finland (fulacimstat = 13, placebo = 6) | 339.7 (246.9) | 295.8 (231.3) | 0.871 (63.5) | 138.6 (90.7) | 116.6 (187.8) | 0.841 (70.0) | 1.070 (0.594–1.929) | 0.8422 |
| Spain (fulacimstat = 12, placebo = 5) | 207.1 (271.9) | 268.8 (158.3) | 1.298 (117.1) | 198.4 (145.4) | 214.7 (187) | 1.082 (58.8) | 0.828 (0.442–1.551) | 0.6062 |
UACRc values are given as geometric means (geometric CV%).
One subject in the fulacimstat group did not have eGFR data at Visit 1. Subgroups for Sweden, Denmark and Italy were too small for analysis of covariance analysis and are not depicted. P-values are exploratory and not adjusted for multiple testing.
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