Table 1.

Baseline characteristics, medical history and concomitant medication

ParameterPlacebo, n = 48Fulacimstat, n = 99Total, n = 147
Male sex, %40 (83.3)84 (84.8)124 (84.4)
Age, years66.5 ± 7.869.1 ± 6.368.2 ± 6.9
BMI, kg/m231.2 ± 4.731.4 ± 4.931.3 ± 4.8
Systolic blood pressure, mmHg139 ± 16135 ± 13136 ± 14
Diastolic blood pressure, mmHg77 ± 974 ± 1075 ± 10
High albuminuria, %32 (66.7)78 (78.8)110 (74.8)
UACR at Visit 1, mg/g140 (31–2429)129 (29–2165)131 (29–2429)
eGFR ≤60 mL/min/1.73 m2, %22 (45.8)49 (49.5)71 (48.3)
eGFR at Visit 1, mL/min/1.73 m261.2 ± 16.560.5 ± 17.260.8 ± 16.9
Medical history,a %
Arterial hypertension47 (97.9)98 (99.0)145 (98.6)
Cardiovascular comorbidities33 (68.7)62 (62.6)95 (64.6)
Hyperlipidaemia/dyslipidaemia25 (52.1)51 (51.5)76 (51.7)
Obesity19 (39.6)41 (41.4)60 (40.8)
Diabetic neuropathy16 (33.3)23 (23.2)39 (26.5)
Diabetic retinopathy10 (20.8)25 (25.3)35 (23.8)
Hypercholesterinaemia8 (16.7)25 (25.3)33 (22.4)
Comedication,a %
ACEis15 (31.3)24 (24.2)39 (26.5)b
Ang II receptor blockers (%)33 (68.7)74 (74.7)107 (72.8)b
β-blockers31 (64.6)61 (61.6)92 (62.6)
Calcium channel blockers34 (70.8)64 (64.6)98 (66.7)
Diuretics26 (54.2)59 (59.6)85 (57.8)
Metformin40 (83.3)76 (76.8)116 (78.9)
Insulin and analogues20 (41.7)49 (49.5)69 (46.9)
DPP4 inhibitors17 (35.4)31 (31.3)48 (32.7)
SGLT2 inhibitors17 (35.4)32 (32.3)49 (33.3)
GLP-1 analogues14 (29.2)23 (23.2)37 (25.2)
Sulphonylureas14 (29.2)17 (17.2)31 (21.1)
Statins37 (77.1)78 (78.8)115 (78.2)
Acetylsalicylic acid21 (43.8)49 (49.5)70 (47.6)
Proton pump inhibitors9 (18.8)30 (30.3)39 (26.5)
ParameterPlacebo, n = 48Fulacimstat, n = 99Total, n = 147
Male sex, %40 (83.3)84 (84.8)124 (84.4)
Age, years66.5 ± 7.869.1 ± 6.368.2 ± 6.9
BMI, kg/m231.2 ± 4.731.4 ± 4.931.3 ± 4.8
Systolic blood pressure, mmHg139 ± 16135 ± 13136 ± 14
Diastolic blood pressure, mmHg77 ± 974 ± 1075 ± 10
High albuminuria, %32 (66.7)78 (78.8)110 (74.8)
UACR at Visit 1, mg/g140 (31–2429)129 (29–2165)131 (29–2429)
eGFR ≤60 mL/min/1.73 m2, %22 (45.8)49 (49.5)71 (48.3)
eGFR at Visit 1, mL/min/1.73 m261.2 ± 16.560.5 ± 17.260.8 ± 16.9
Medical history,a %
Arterial hypertension47 (97.9)98 (99.0)145 (98.6)
Cardiovascular comorbidities33 (68.7)62 (62.6)95 (64.6)
Hyperlipidaemia/dyslipidaemia25 (52.1)51 (51.5)76 (51.7)
Obesity19 (39.6)41 (41.4)60 (40.8)
Diabetic neuropathy16 (33.3)23 (23.2)39 (26.5)
Diabetic retinopathy10 (20.8)25 (25.3)35 (23.8)
Hypercholesterinaemia8 (16.7)25 (25.3)33 (22.4)
Comedication,a %
ACEis15 (31.3)24 (24.2)39 (26.5)b
Ang II receptor blockers (%)33 (68.7)74 (74.7)107 (72.8)b
β-blockers31 (64.6)61 (61.6)92 (62.6)
Calcium channel blockers34 (70.8)64 (64.6)98 (66.7)
Diuretics26 (54.2)59 (59.6)85 (57.8)
Metformin40 (83.3)76 (76.8)116 (78.9)
Insulin and analogues20 (41.7)49 (49.5)69 (46.9)
DPP4 inhibitors17 (35.4)31 (31.3)48 (32.7)
SGLT2 inhibitors17 (35.4)32 (32.3)49 (33.3)
GLP-1 analogues14 (29.2)23 (23.2)37 (25.2)
Sulphonylureas14 (29.2)17 (17.2)31 (21.1)
Statins37 (77.1)78 (78.8)115 (78.2)
Acetylsalicylic acid21 (43.8)49 (49.5)70 (47.6)
Proton pump inhibitors9 (18.8)30 (30.3)39 (26.5)

Continuous data are depicted as mean ± SD or as median (range) in case of UACR.

a

Cutoff >20% in total population.

b

One patient did neither receive an ACEi nor an ARB.

Table 1.

Baseline characteristics, medical history and concomitant medication

ParameterPlacebo, n = 48Fulacimstat, n = 99Total, n = 147
Male sex, %40 (83.3)84 (84.8)124 (84.4)
Age, years66.5 ± 7.869.1 ± 6.368.2 ± 6.9
BMI, kg/m231.2 ± 4.731.4 ± 4.931.3 ± 4.8
Systolic blood pressure, mmHg139 ± 16135 ± 13136 ± 14
Diastolic blood pressure, mmHg77 ± 974 ± 1075 ± 10
High albuminuria, %32 (66.7)78 (78.8)110 (74.8)
UACR at Visit 1, mg/g140 (31–2429)129 (29–2165)131 (29–2429)
eGFR ≤60 mL/min/1.73 m2, %22 (45.8)49 (49.5)71 (48.3)
eGFR at Visit 1, mL/min/1.73 m261.2 ± 16.560.5 ± 17.260.8 ± 16.9
Medical history,a %
Arterial hypertension47 (97.9)98 (99.0)145 (98.6)
Cardiovascular comorbidities33 (68.7)62 (62.6)95 (64.6)
Hyperlipidaemia/dyslipidaemia25 (52.1)51 (51.5)76 (51.7)
Obesity19 (39.6)41 (41.4)60 (40.8)
Diabetic neuropathy16 (33.3)23 (23.2)39 (26.5)
Diabetic retinopathy10 (20.8)25 (25.3)35 (23.8)
Hypercholesterinaemia8 (16.7)25 (25.3)33 (22.4)
Comedication,a %
ACEis15 (31.3)24 (24.2)39 (26.5)b
Ang II receptor blockers (%)33 (68.7)74 (74.7)107 (72.8)b
β-blockers31 (64.6)61 (61.6)92 (62.6)
Calcium channel blockers34 (70.8)64 (64.6)98 (66.7)
Diuretics26 (54.2)59 (59.6)85 (57.8)
Metformin40 (83.3)76 (76.8)116 (78.9)
Insulin and analogues20 (41.7)49 (49.5)69 (46.9)
DPP4 inhibitors17 (35.4)31 (31.3)48 (32.7)
SGLT2 inhibitors17 (35.4)32 (32.3)49 (33.3)
GLP-1 analogues14 (29.2)23 (23.2)37 (25.2)
Sulphonylureas14 (29.2)17 (17.2)31 (21.1)
Statins37 (77.1)78 (78.8)115 (78.2)
Acetylsalicylic acid21 (43.8)49 (49.5)70 (47.6)
Proton pump inhibitors9 (18.8)30 (30.3)39 (26.5)
ParameterPlacebo, n = 48Fulacimstat, n = 99Total, n = 147
Male sex, %40 (83.3)84 (84.8)124 (84.4)
Age, years66.5 ± 7.869.1 ± 6.368.2 ± 6.9
BMI, kg/m231.2 ± 4.731.4 ± 4.931.3 ± 4.8
Systolic blood pressure, mmHg139 ± 16135 ± 13136 ± 14
Diastolic blood pressure, mmHg77 ± 974 ± 1075 ± 10
High albuminuria, %32 (66.7)78 (78.8)110 (74.8)
UACR at Visit 1, mg/g140 (31–2429)129 (29–2165)131 (29–2429)
eGFR ≤60 mL/min/1.73 m2, %22 (45.8)49 (49.5)71 (48.3)
eGFR at Visit 1, mL/min/1.73 m261.2 ± 16.560.5 ± 17.260.8 ± 16.9
Medical history,a %
Arterial hypertension47 (97.9)98 (99.0)145 (98.6)
Cardiovascular comorbidities33 (68.7)62 (62.6)95 (64.6)
Hyperlipidaemia/dyslipidaemia25 (52.1)51 (51.5)76 (51.7)
Obesity19 (39.6)41 (41.4)60 (40.8)
Diabetic neuropathy16 (33.3)23 (23.2)39 (26.5)
Diabetic retinopathy10 (20.8)25 (25.3)35 (23.8)
Hypercholesterinaemia8 (16.7)25 (25.3)33 (22.4)
Comedication,a %
ACEis15 (31.3)24 (24.2)39 (26.5)b
Ang II receptor blockers (%)33 (68.7)74 (74.7)107 (72.8)b
β-blockers31 (64.6)61 (61.6)92 (62.6)
Calcium channel blockers34 (70.8)64 (64.6)98 (66.7)
Diuretics26 (54.2)59 (59.6)85 (57.8)
Metformin40 (83.3)76 (76.8)116 (78.9)
Insulin and analogues20 (41.7)49 (49.5)69 (46.9)
DPP4 inhibitors17 (35.4)31 (31.3)48 (32.7)
SGLT2 inhibitors17 (35.4)32 (32.3)49 (33.3)
GLP-1 analogues14 (29.2)23 (23.2)37 (25.2)
Sulphonylureas14 (29.2)17 (17.2)31 (21.1)
Statins37 (77.1)78 (78.8)115 (78.2)
Acetylsalicylic acid21 (43.8)49 (49.5)70 (47.6)
Proton pump inhibitors9 (18.8)30 (30.3)39 (26.5)

Continuous data are depicted as mean ± SD or as median (range) in case of UACR.

a

Cutoff >20% in total population.

b

One patient did neither receive an ACEi nor an ARB.

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