NEWS HIGHLIGHTS
Published Studies Related to Sensipar (Cinacalcet)
Cinacalcet lowers serum alkaline phosphatase in maintenance hemodialysis patients. [2009.03]
BACKGROUND AND OBJECTIVES: Studies suggest an association between elevated serum alkaline phosphatase (AP) and increased mortality in hemodialysis patients, but the effect of existing therapies on AP is not fully understood. We assessed the effects of cinacalcet on AP in a secondary analysis of controlled trial data... CONCLUSIONS: In this combined analysis of controlled trials of patients who were receiving hemodialysis, cinacalcet lowered total serum AP.
Treatment of secondary hyperparathyroidism in CKD patients with cinacalcet and/or vitamin D derivatives. [2009.01]
The discovery of the calcium-sensing receptor (CaR) 15 yr ago was rapidly followed by the development of drugs modulating its activity, the so-called calcimimetics (increasing the CaR signal) and calcilytics (decreasing the CaR signal). The indication for calcimimetics is treatment of primary and secondary hyperparathyroidism, whereas calcilytics have potential for treatment of osteoporosis.
Impact of vitamin D dose on biochemical parameters in patients with secondary hyperparathyroidism receiving cinacalcet. [2009]
BACKGROUND/AIMS: The calcimimetic cinacalcet (Mimpara/Sensipar) simultaneously lowers parathyroid hormone (PTH), phosphorus (P) and calcium (Ca) levels in patients with secondary hyperparathyroidism. The OPTIMA study demonstrated that cinacalcet and adjusted doses of vitamin D maximized control of these parameters. This post-hoc analysis of OPTIMA data assessed the impact of reducing or increasing the dose of concomitant vitamin D on PTH, P and Ca in patients receiving cinacalcet... CONCLUSIONS: After initiating cinacalcet, the dose of vitamin D can be adjusted to maximize reductions in PTH, P and Ca; however, vitamin D-induced decreases in PTH need to be balanced with the diminished response in P and Ca. Copyright 2009 S. Karger AG, Basel.
Cinacalcet HCl and concurrent low-dose vitamin D improves treatment of secondary hyperparathyroidism in dialysis patients compared with vitamin D alone: the ACHIEVE study results. [2008.11]
BACKGROUND AND OBJECTIVES: Patients with chronic kidney disease (CKD) receiving dialysis often develop secondary hyperparathyroidism with disturbed calcium and phosphorus metabolism. The National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (KDOQI) was established to guide treatment practices for these disorders. The ACHIEVE study was designed to test two treatment strategies for achieving KDOQI goals... CONCLUSIONS: Achievement of KDOQI targets was difficult, especially with Flex-D. Maintaining calcium and phosphorus target values precluded the use of vitamin D doses necessary to lower PTH to within the narrow target range and highlighted limitations inherent to the KDOQI treatment algorithm.
Cinacalcet for secondary hyperparathyroidism in children with end-stage renal disease. [2008.10]
The efficacy and acceptability of cinacalcet for treatment of secondary hyperparathyroidism (SHPT) was assessed in seven pediatric patients suffering from end-stage renal disease (ESRD) presenting with inadequately controlled SHPT despite conventional management...
Clinical Trials Related to Sensipar (Cinacalcet)
Safety and Efficacy Study of AMG 073 in Hemodialysis Subjects [Completed]
Subjects on Hemodialysis will be randomized to AMG 073 or placebo. The screening period is a
maximum of 30 days followed by a 26-week treatment period. Lab assessments will be completed
throughout the study along with PRO assessments.
SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism [Completed]
The purpose of this study is to demonstrate that the efficacy of cinacalcet when
co-administered with the first meal after dialysis is comparable (non-inferior) to the
efficacy of cinacalcet when administered during the dialysis study visit.
START: Sensipar Treatment Algorithm to Reach K/DOQI Targets in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism [Completed]
The purpose of this research is to study the effects and safety of Sensipar approved by the
Food and Drug Administration (FDA) in patients with kidney failure who are being treated with
dialysis and have uncontrolled secondary hyperparathyroidism (HPT).
Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis [Completed]
The purpose of this study is to evaluate the efficacy and safety of cinacalcet compared with
placebo in patients with stage 3 and 4 Chronic Kidney Disease (CKD).
Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Subjects With PHPT Unable to Undergo Parathyroidectomy [Not yet recruiting]
This phase 3, randomized, double-blind, placebo-controlled study is designed to demonstrate
the efficacy and to assess the safety of cinacalcet for the reduction of hypercalcemia in
subjects with primary HPT for whom parathyroidectomy is indicated on the basis of an
elevated corrected total serum calcium, but who are unable to undergo parathyroidectomy.
The reasons a subject would be unable to undergo parathyroidectomy include failed
parathyroidectomy, medical contraindication to surgery, or because together with their
primary physician they decided it was inappropriate. The study will consist of a 30-day
screening phase, a 12-week placebo-controlled dose-titration phase, and a 16 week
placebo-controlled efficacy assessment phase (EAP). Subjects who complete 28 weeks on study
will continue into an open-label safety extension phase for 24 weeks of investigational
cinacalcet treatment.
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