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) | Â | Â | Â |
 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) | Â | Â | Â |
 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) | Â | Â | Â |
 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) |