An open-label phase 2 trial to assess the efficacy, safety and pharmacokinetics of lanthanum carbonate in hyperphosphatemic children and adolescents with chronic kidney disease undergoing dialysis

Table 2 Proportion of patients achieving age-specific KDOQI serum phosphorus target levels after 8 weeks of treatment

	Per-protocol set 1		Per-protocol set 2	Full analysis set^c
	CC (n = 17)	LC (n = 17)	LC (n = 34)	LC (n = 52)
Responders, n (%)^a	10 (58.8)	12 (70.6)	17 (50.0)	18 (34.6)
95% CI for percentage of responders^b	32.9, 81.6	44.0, 89.7	32.4, 67.6	22.0, 49.1

Recorded 8-week treatment periods occurred during part 2 and/or part 3 of the study. Per-protocol set 1 included all patients who received CC for 8 weeks during part 2, followed by a washout period and then LC for at least 8 weeks during part 2, and who had serum phosphorus data available for analysis. Per-protocol set 2 included all patients who received LC for at least 8 weeks during part 2 and/or part 3, and who had serum phosphorus data available for analysis. The full analysis set included all patients who received at least one dose of study drug during part 2 and/or part 3 and who had serum phosphorus data available for analysis. The primary efficacy endpoint is shaded in grey
^aResponders were defined as patients with KDOQI serum phosphorus levels of ≤1.78 mmol/L (patients ≥12 years to < 18 years old) and ≤ 1.94 mmol/L (patients ≥10 years to < 12 years old)
^bThe 95% CI for the percentage of responders was calculated using the Clopper–Pearson method
^cFor patients who had missing central laboratory data, local laboratory data were used, if available; otherwise, patients were excluded from relevant analyses
CC calcium carbonate, CI confidence interval, KDOQI Kidney Disease Outcomes Quality Initiative, LC lanthanum carbonate

ISSN: 1471-2369