|
Adverse events (week 96)
|
TDF (N = 75)
|
|---|
|
n (%)
|
|---|
|
On-therapy AE
|
58 (77)
|
|
On-therapy serious AE
|
2 (3)
|
|
On-therapy AE leading to study withdrawal
|
1 (1)
|
|
Drug-related AE
|
18 (24)
|
|
Drug-related urine beta-2-microglobulin increase
|
15 (20)
|
|
Renal tubular disorder
|
1 (1)
|
|
Renal tubular dysfunction
|
1 (1)
|
|
Prothrombin time prolonged
|
1 (1)
|
|
Other key safety endpoints
|
n
|
Median (min, max)
|
Median change from baseline (min, max)
|
|---|
|
Serum creatinine (mg/dL)
| | | |
|
Baseline
|
75
|
0.70 (0.38, 1.01)
| |
|
Week 4
|
75
|
0.71 (0.44, 1.02)
|
0.01 (−0.14, 0.20)
|
|
Week 24
|
74
|
0.74 (0.41, 1.05)
|
0.02 (−0.08, 0.15)
|
|
Week 48
|
73
|
0.72 (0.42, 1.09)
|
0.04 (−0.11, 0.12)
|
|
Week 96
|
72
|
0.76 (0.45, 1.02)
|
0.06 (−0.10, 0.17)
|
|
eGFR by JSN-CKDI (mL/min/1.73m2)
| | | |
|
Baseline
|
75
|
86 (60, 135)
| |
|
Week 4
|
75
|
84 (60, 138)
|
−2.0 (−21, 20)
|
|
Week 24
|
74
|
81 (57, 124)
|
−3.0 (−21, 13)
|
|
Week 48
|
73
|
82 (56, 124)
|
−6.0 (−20, 12)
|
|
Week 96
|
72
|
79.0 (52, 118)
|
−9.5 (−24, 14)
|
|
Urine beta-2-microglobulin ratio (µg/g creatinine)
|
|
Baseline
|
75
|
154.91 (40.71, 1636.09)
| |
|
Week 4
|
75
|
198.91 (25.72, 4779.66)
|
45.02 (−317.50, 3143.57)
|
|
Week 24
|
74
|
185.88 (8.93, 9006.76)
|
41.17 (−361.52, 7890.23)
|
|
Week 48
|
73
|
192.50 (13.02, 10,546.26)
|
38.16 (−582.24, 9429.72)
|
|
Week 96
|
72
|
154.96 (11.20, 9052.18)
|
15.19 (−166.80, 7935.65)
|
|
Serum phosphorus (mg/dL)
| | | |
|
Baseline
|
75
|
3.3 (1.9, 4.4)
| |
|
Week 4
|
75
|
3.2 (2.0, 4.4)
|
−0.10 (−1.0, 0.9)
|
|
Week 24
|
74
|
3.3 (1.4, 4.5)
|
−0.10 (−1.1, 1.4)
|
|
Week 48
|
73
|
3.3 (2.0, 4.7)
|
0.00 (−1.3, 0.9)
|
|
Week 96
|
72
|
3.4 (2.2, 4.5)
|
0.10 (−1.1, 1.2)
|
|
%TRP
|
|
Baseline
|
75
|
89.92 (77.91, 97.71)
| |
|
Week 4
|
75
|
88.49 (77.04, 98.79)
|
−0.69 (−13.26, 6.75)
|
|
Week 24
|
74
|
90.20 (78.96, 96.26)
|
−0.52 (−11.81, 9.75)
|
|
Week 48
|
73
|
89.44 (81.51, 97.71)
|
0.17 (−8.71, 8.27)
|
|
Week 96
|
72
|
89.83 (81.07, 96.90)
|
−0.818 (−10.25, 15.47)
|
|
ALT (U/L)
|
|
Baseline
|
75
|
19.0 (7, 147)
| |
|
Week 4
|
75
|
22.0 (8, 141)
|
4.0 (−14, 60)
|
|
Week 24
|
74
|
22.5 (10, 130)
|
4.0 (−32, 61)
|
|
Week 48
|
73
|
23.0 (12, 83)
|
4.0 (−79, 23)
|
|
Week 96
|
72
|
21.5 (11, 220)
|
2.5 (−20, 73)
|
|
BMD safety endpoints
|
n
|
Median (min, max)
|
Median % change from baseline (min, max)
|
|---|
|
BMD, femur (g/cm2)
|
|
Baseline
|
23
|
0.83 (0.64, 0.99)
| |
|
Week 96
|
23
|
0.80 (0.66, 1.00)
|
−2.09 (−12.67, 6.59)
|
|
BMD, lumbar vertebra (g/cm2)
|
|
Baseline
|
75
|
1.00 (0.63, 1.43)
| |
|
Week 96
|
72
|
0.96 (0.64, 1.52)
|
−2.24 (−12.21, 6.73)
|
- AE adverse event, ALT alanine aminotransferase, BMD bone mineral density, eGFR by JSN-CKDI estimated glomerular filtration rate calculated by the Japanese Society of Nephrology-Chronic Kidney Disease Initiatives (JSN-CKDI) equation, SD standard deviation, SP safety population, TDF tenofovir disoproxil fumarate, TRP renal tubular reabsorption of phosphate
