Control of Phosphorus

Multiple studies have demonstrated that Sensipar® can help achieve phosphorus treatment goal1-6*

Data on file, Amgen.2 Pooled phase 3 studies published in: Moe et al, Kidney Int, 2005.1

Phase 3 results based on three 6-month, multicenter, randomized, double-blind, placebo-controlled clinical studies conducted in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (HPT) on dialysis (N = 1,136).1 Click here for Phase 3 summary description.

*KDOQI™ goal was defined as mean phosphorus 3.5-5.5 mg/dL.
†Mean phosphorus was within KDOQI™ target range by study end.

In addition to the phase 3 trials, 3 other studies demonstrated the phosphorus-lowering efficacy of Sensipar®: OPTIMA, TARGET, and CONTROL.1-5

CONTROL was a multicenter, open-label study in hemodialysis patients with controlled parathyroid hormone (PTH)‡ and uncontrolled calcium-phosphorus product (Ca x P) (N = 72). Key inclusion criteria were controlled iPTH 150 to 300 pg/mL, mean
Ca x P > 55 mg2/dL2, mean albumin-corrected serum Ca
≥ 8.4 mg/dL, and IV active vitamin D derivatives (doses of paricalcitol > 6 mcg, doxercalciferol > 3 mcg, or calcitriol
> 1.5 mcg/wk) during the 30 days before study treatment. Vitamin D doses were reduced at day 1 to 2 mcg paricalcitol or equivalent§ per dialysis treatment. Sensipar® was initiated at a dose of 30 mg per day and was titrated sequentially every 2 weeks for 8 weeks until the maximum dose of 180 mg per day was reached (or an adverse event prevented a dose increase).5

OPTIMA results are based on a multicenter, open-label study conducted in patients on dialysis with uncontrolled secondary HPT (N = 552).3 Click here for OPTIMA summary description.

TARGET results are from a multicenter, single-arm, open-label study in patients on dialysis with moderate to severe secondary HPT (N = 444).4 Click here for TARGET summary description.

Adding Sensipar® to low mean doses of vitamin D and phosphate binders improved phosphorus reductions2

Data on file, Amgen.2 OPTIMA results published in: Messa et al, Clin J Am Soc Nephrol, 2008.3 In the OPTIMA study, the mean vitamin D dose was 11.8 mcg per week.2 The total n number for each subgroup varied.

In the OPTIMA study, a multicenter, open-label study conducted in patients on dialysis with uncontrolled secondary HPT (N = 552), Sensipar® enabled greater decreases in phosphorus with lower doses of vitamin D. The mean vitamin D dose was 11.8 mcg per week.2 Traditional therapy included vitamin D and phosphate binders, if prescribed.3 Click here for the OPTIMA summary description.

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‡When the CONTROL trial was designed and implemented, the Nichols biointact PTH (biPTH) assay was used to determine PTH levels. Since the biPTH assay is no longer available, biPTH values will be reported as iPTH, using the conversion factor of approximately 0.54.7 Based on this conversion, biPTH 80 to 160 pg/mL ≈ iPTH 150 to 300 pg/mL.
§Paricalcitol equivalents defined as paricalcitol 2.0 mcg =
doxercalciferol 1.0 mcg = calcitriol 0.5 mcg.

KDOQI™ is a trademark of the National Kidney Foundation, Inc.