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paricalcitol injection Clinical Studies

14 CLINICAL STUDIES

The safety and efficacy of Paricalcitol Injection have been established based on adult studies of another paricalcitol injection product in patients with CKD on hemodialysis. Below is a display of the results of these studies of paricalcitol injection.

Adult Studies in CKD on Dialysis

Three 12-week, placebo-controlled studies were conducted with paricalcitol injection in 78 patients with chronic kidney disease on dialysis. In these studies, patients ranged in age from 22 to 90 years, 51% were males, 13% were Caucasian, 79% were African-American, and 8% were Hispanic. The most common causes of renal failure were hypertension and diabetes. The dose of paricalcitol injection was started at 0.04 mcg/kg 3 times per week intravenously. The dose was increased by 0.04 mcg/kg every 2 weeks until intact PTH levels were decreased at least 30% from baseline or a fifth escalation brought the dose to 0.24 mcg/kg, or intact PTH fell to less than 100 pg/mL, or the Ca × P product was greater than 75 within any 2 week period, or serum calcium became greater than 11.5 mg/dL at any time.

Patients treated with paricalcitol injection achieved a mean intact PTH reduction of 30% within 6 weeks. The results from these studies are as follows:

Table 6: Mean Changes from Baseline to Final Evaluation in Intact PTH, Alkaline Phosphatase, Phosphorus and Calcium × Phosphorus Product in Adult Patients with CKD on Dialysis in Three 12-Week Placebo-Controlled Studies
Group
(No. of Pts.)
Baseline Mean
(Range)
Mean (SE) Change From Baseline to Final Evaluation
Intact PTH (pg/mL)Paricalcitol injection
(n=40)
783 (291 – 2076)-379 (43.7)
Placebo
(n=38)
745 (320 – 1671)-69.6 (44.8)
Alkaline Phosphatase
(U/L)
Paricalcitol injection
(n=31)
150 (40 – 600)-41.5 (10.6)
Placebo
(n=34)
169 (56 – 911)+2.6 (10.1)
Phosphorus (mg/dL)Paricalcitol injection
(n=40)
5.8 (3.7 – 10.2)+0.47 (0.3)
Placebo
(n=38)
6.0 (2.8 – 8.8)-0.47 (0.3)
Calcium × Phosphorus ProductParicalcitol injection
(n=40)
54 (32 – 106)+7.9 (2.2)
Placebo
(n=38)
54 (26 – 77)-3.9 (2.3)

Pediatric Study in CKD on Dialysis

Paricalcitol injection was evaluated in a 12-week randomized, double-blind, placebo-controlled study of 29 pediatric patients, aged 5 to 19 years, with CKD on hemodialysis; nearly all had received some form of vitamin D prior to the study. Of the 29 patients, 76% were male, 52% were Caucasian and 45% were African-American. The initial dose of paricalcitol injection was 0.04 mcg/kg 3 times per week, based on baseline intact PTH level of less than 500 pg/mL, or 0.08 mcg/kg 3 times per week, based on baseline intact PTH level of 500 pg/mL or greater. The dose of paricalcitol injection was adjusted in 0.04 mcg/kg increments based on the levels of serum intact PTH, calcium and Ca × P. The mean baseline levels of intact PTH were 841 pg/mL for the 15 patients treated with paricalcitol injection and 740 pg/mL for the 14 placebo-treated patients. The mean dose of paricalcitol injection administered was 4.6 mcg (range: 0.8 mcg to 9.6 mcg). Sixty-seven percent of the patients treated with paricalcitol injection and 14% of the placebo-treated patients completed the trial. Seventy-one percent of the placebo-treated patients discontinued due to excessive elevations in intact PTH levels, as defined by 2 consecutive intact PTH levels greater than 700 pg/mL and greater than baseline after 4 weeks of treatment.

The primary efficacy analysis demonstrated that 60% of patients treated with paricalcitol injection and 21% of placebo-treated patients achieved two consecutive greater than or equal to 30% reductions from baseline in intact PTH.

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