Introduction
Methods
Statistical analyses
Results
Characteristic | Baseline (n = 55) | At First Visit (n = 55) | P-value |
---|---|---|---|
Age (years) | |||
Female sex, n (%) | 24 (43.6%) | – | |
Diabetes mellitus | 4 (7.3%) | ||
Previous immunosuppressants | 48 (87.3%) | – | |
Receiving immunosuppressants at baselinea | 36 (65.5%) | ||
Receiving TW at baselinea | 20 (36.4%) | – | |
Receiving RASi at baseline | 50 (90.9%) | – | |
Proteinuria (g/24 h) | 2.2 (1.5–3.2) | 0.94 (0.61–1.65) | < 0.001 |
Mean artery pressure (MAP, mmHg) | 94.4 ± 10.6 | 89.1 ± 10.9 | < 0.001 |
Estimated GFR (ml/min per 1.73 m2) | 65 ± 13 | 65 ± 14 | 0.71 |
Estimated GFR < 60 ml/min per 1.73 m2 | 21 (38.2%) | 21 (38.2%) | |
Serum albumin (g/dl) | 4.05 ± 0.35 | 3.66 ± 0.42 | < 0.001 |
Total cholesterol (mg/dL) | 216.6 ± 46.4 | 247.5 ± 50.3 | < 0.001 |
Triglyceride ((mg/dL) | 168.3 ± 79.7 | 141.7 ± 70.9 | 0.06 |
LDL cholesterol (mg/dL) | 119.9 ± 34.8 | 147.0 ± 46.4 | < 0.001 |
HDL cholesterol (mg/dl) | 46.4 ± 11.6 | 61.9 ± 15.5 | < 0.001 |
White blood cell count (WBC, 10^9/L) | 6.9 ± 2.4 | 6.1 ± 2.1 | 0.006 |
Alanine aminotransferase (ALT, U/L) | 24 (14–37) | 27 (21–49) | < 0.001 |
Aspartate aminotransferase (AST, U/L) | 23 (20–29) | 27 (23–32) | < 0.001 |
Proteinuria changes at the first and second follow-ups after KX treatment
Characteristic | n = 32 | Remissions n = 23 | P-value |
---|---|---|---|
Age (years) | 39.5 ± 8.2 | 36.9 ± 7.7 | 0.24 |
Female sex, n (%) | 23 (71.9%) | 8 (34.8%) | 0.01 |
Diabetes mellitus | 4 (12.5%) | 0 (0.0%) | 0.22 |
Previous immunosuppressantsa | 28 (87.5%) | 20 (87.0%) | 1.0 |
Receiving immunosuppressants at baselinea | 23 (71.9%) | 13 (56.5%) | 0.37 |
Receiving TW at baselinea | 16 (50.0%) | 4 (17.4%) | 0.03 |
Receiving RASi at baseline | 27 (84.4%) | 23 (100.0%) | 0.13 |
Proteinuria (g/24 h) | 2.4 (1.9, 3.5) | 1.8 (1.5, 2.3) | 0.01 |
Mean artery pressure at baseline (mmHg) | 96.8 ± 11.0 | 91.0 ± 9.2 | 0.05 |
estimated GFR (ml/min per 1.73 m2) | 63 ± 13 | 68 ± 11 | 0.14 |
eGFR < 60 ml/min per 1.73 m2 | 15 (46.9) | 6 (26.1) | 0.20 |
Serum albumin (g/dl) | 39.6 (3.5) | 41.7 (3.3) | 0.03 |
KuXian Dosage (ug) | 102 ± 24 | 100 ± 26 | 0.71 |
Proteinuria remission after KX treatment
Proteinuria changes when discontinued the KX treatment
Factors associated with proteinuria remission after KX treatment
Factor a | Complete or Partial remission | Complete remission | ||||
---|---|---|---|---|---|---|
HR | 95% CI | P value | HR | 95% CI | P value | |
Sex (Female) | 3.67 | 1.63–8.27 | 0.001 | 3.62 | 1.39–9.42 | 0.008 |
Age at baseline (For every 10 years old) | 0.98 | 0.93–1.03 | 0.41 | 1.01 | 0.95–1.07 | 0.68 |
Proteinuria at baseline (g/24 h) b | 0.17 | 0.04–0.85 | 0.03 | 0.02 | 0.002–0.29 | 0.003 |
eGFR at baseline (For every 10 ml/min per 1.73 m2) | 0.92 | 0.66–1.29 | 0.64 | 1.49 | 0.88–2.55 | 0.14 |
Mean artery pressure at baseline (For every 10 mmHg) | 1.03 | 0.97–1.55 | 0.88 | 0.85 | 0.49–1.48 | 0.57 |
Switching from TW | 0.22 | 0.08–0.55 | 0.001 | 0.15 | 0.04–0.57 | 0.005 |
KX Dosage (For every 20μg per capsule) | 1.33 | 0.93–1.91 | 0.12 | 2.62 | 1.47–4.69 | 0.001 |
Safety and adverse events
Adverse Events | N (%) |
---|---|
Oligomenorrhea or menstrual irregularity a | 12 of 20 (60%) |
Amenorrhea a | 10 of 20 (50%) |
Abdominal pain | 2 |
Liver injuryb | 3 (5.5%) |
Skin pigmentation | 2 |