Table 3.
Serum phosphorus levels and number of patients at each time point according to treatment group (efficacy population)
| Time Point (wk) | PA21 1.25 g/d (1 tablet) | PA21 5.0 g/d (4 tablets) | PA21 7.5 g/d (6 tablets) | PA21 10.0 g/d (8 tablets) | PA21 12.5 g/d (10 tablets) | Sevelamer (HCl) 4.8 g/d (6 tablets) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean ± SD | n | Mean ± SD | n | Mean ± SD | n | Mean ± SD | n | Mean ± SD | n | Mean ± SD | n | |
| Baseline 1 | 6.82±1.64 | 26 | 6.61±1.08 | 26 | 6.85±1.15 | 25 | 6.77±1.75 | 25 | 6.47±1.19 | 24 | 6.94±1.61 | 24 |
| 2 | 6.72±1.59 | 26 | 5.50±1.26 | 26 | 5.58±1.19 | 25 | 5.29±1.81 | 24 | 5.06±1.13 | 24 | 5.68±1.42 | 24 |
| 3 | 6.88±1.46 | 26 | 5.51±1.65 | 25 | 5.50±1.57 | 24 | 5.13±1.50 | 22 | 4.82±1.05 | 21 | 5.11±1.64 | 22 |
| 4 | 6.78±1.50 | 24 | 5.43±0.98 | 23 | 5.92±1.38 | 22 | 5.07±1.69 | 21 | 5.09±1.28 | 21 | 5.38±1.45 | 22 |
| 5 | 6.67±1.65 | 24 | 5.12±1.66 | 21 | 5.70±1.06 | 21 | 5.12±1.04 | 19 | 4.89±1.48 | 20 | 5.33±1.20 | 20 |
| 6 | 6.61±1.81 | 22 | 5.78±1.54 | 20 | 5.61±1.13 | 20 | 5.10±1.17 | 16 | 5.03±1.51 | 16 | 5.63±1.30 | 18 |
| 7 | 6.76±1.37 | 19 | 5.89±1.70 | 17 | 5.90±1.10 | 20 | 5.04±1.44 | 14 | 5.36±1.48 | 15 | 5.63±1.32 | 19 |
| Follow-up 1 | 6.70±1.17 | 21 | 6.34±2.21 | 19 | 7.00±1.46 | 20 | 7.10±2.01 | 16 | 6.77±1.46 | 16 | 6.63±1.07 | 19 |
| Follow-up 2 | 6.56±1.35 | 19 | 6.53±1.35 | 17 | 6.99±1.40 | 19 | 6.62±1.85 | 14 | 6.52±1.55 | 16 | 6.55±1.45 | 19 |
Values are shown as mean ± SD in mg/dl. Data at follow-up 1 and follow-up 2 were obtained during the 2-week run-out phase when patients stopped taking phosphate binders. If a patient was prematurely withdrawn from the study for any reason after start of treatment, the investigator made every effort to perform the evaluations described for the follow-up 1 visit, as soon as possible after the last study treatment administration, and 1 week later the evaluations as described for the follow-up 2 visit. If it was not possible to carry out both of these early termination visits, at least the evaluations of the follow-up 2 visit were performed.