NEWS HIGHLIGHTSMedia Articles Related to Sensipar (Cinacalcet)
FDA Suspends Sensipar Trials Following Death Of Teenager
Source: Clinical Trials / Drug Trials News From Medical News Today [2013.02.28]
The U.S. Food and Drug Administration recently announced it has stopped all pediatric clinical trials of the drug Sensipar, following the death of a 14 year old patient who took part in one of the studies. Sensipar is a drug, developed by Amgen Inc, that reduces the levels of calcium in the blood by decreasing the release of parathyroid hormone (PTH) from the parathyroid gland...
Routine Prescribing Of Cinacalcet For End Stage Kidney Disease No Longer Warranted
Source: Urology / Nephrology News From Medical News Today [2013.05.02]
Cinacalcet, a drug commonly given to patients with end stage kidney disease to help keep phosphorus and parathyroid blood levels within a target range and has few patient level clinical benefits and several adverse effects, suggesting that it should no longer be routinely prescribed, according to a study by international researchers published in this week's PLOS Medicine...
Routine Use Of Cinacalcet Therapy In People With Chronic Kidney Disease No Longer Recommended
Source: Urology / Nephrology News From Medical News Today [2013.05.02]
Cinacalcet, a drug commonly given to patients with end stage kidney disease to help keep phosphorus and parathyroid blood levels within a target range has few patient level clinical benefits and several adverse effects, suggesting that it should no longer be routinely prescribed, according to a study by international researchers published in this week's PLOS Medicine...
Published Studies Related to Sensipar (Cinacalcet)
A novel dose regimen of cinacalcet in the treatment of severe hyperparathyroidism in hemodialysis patients. [2011.05]
During the recent years, cinacalcet has markedly improved the management of hyperparathyroidism in patients on hemodialysis. However, to the best of our knowledge, there are no specific studies addressing the dose regimen of cinacalcet... Our results indicate that cinacalcet twice weekly is reasonably safe and effective in suppressing high PTH levels in hemodialysis patients, with fewer side effects.
The ADVANCE study: a randomized study to evaluate the effects of cinacalcet plus low-dose vitamin D on vascular calcification in patients on hemodialysis. [2011.04]
BACKGROUND: This prospective, randomized, controlled trial compared the progression of vascular and cardiac valve calcification in 360 prevalent adult hemodialysis patients with secondary hyperparathyroidism treated with either cinacalcet plus low-dose vitamin D sterols or flexible doses of vitamin D sterols alone... CONCLUSIONS: In hemodialysis patients with moderate to severe secondary hyperparathyroidism, cinacalcet plus low-dose vitamin D sterols may attenuate vascular and cardiac valve calcification.
Cinacalcet HCl reduces hypercalcemia in primary hyperparathyroidism across a wide spectrum of disease severity. [2011.01]
CONTEXT: Primary hyperparathyroidism (PHPT) is characterized by elevated serum calcium (Ca) and increased PTH concentrations. OBJECTIVE: The objective of the investigation was to establish the efficacy of cinacalcet in reducing serum Ca in patients with PHPT across a wide spectrum of disease severity... CONCLUSIONS: Cinacalcet is equally effective in the medical management of PHPT patients across a broad spectrum of disease severity, and overall cinacalcet is well tolerated.
Economic analysis of cinacalcet in combination with low-dose vitamin D versus flexible-dose vitamin D in treating secondary hyperparathyroidism in hemodialysis patients. [2010.12]
BACKGROUND: The ACHIEVE (Optimizing the Treatment of Secondary Hyperparathyroidism: A Comparison of Sensipar and Low Dose Vitamin D vs Escalating Doses of Vitamin D Alone) trial evaluated the efficacy of treatment with cinacalcet plus low-dose activated vitamin D analogues (Cinacalcet-D) compared with vitamin D analogues alone (Flex-D) in attaining KDOQI (Kidney Disease Outcomes Quality Initiative) targets for secondary hyperparathyroidism (SHPT). The economic implications of these treatment regimens have not been explored... CONCLUSIONS: Cinacalcet combined with vitamin D analogues was no more effective than vitamin D analogues in achieving the primary ACHIEVE end point and incurred greater costs. This conclusion was not tempered substantially by the cost of vitamin D analogues or oral phosphate binders. Whether the additional costs of cinacalcet are warranted will require longer term models to determine whether changes in serum levels of mineral metabolic markers translate into lower morbidity, mortality, and downstream costs. Copyright (c) 2010 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.
Study design and subject baseline characteristics in the ADVANCE Study: effects of cinacalcet on vascular calcification in haemodialysis patients. [2010.06]
BACKGROUND: The ADVANCE (A Randomized Study to Evaluate the Effects of Cinacalcet plus Low-Dose Vitamin D on Vascular Calcification in Subjects with Chronic Kidney Disease Receiving Haemodialysis) Study objective is to assess the effect of cinacalcet plus low-dose active vitamin D versus flexible dosing of active vitamin D on progression of coronary artery calcification (CAC) in haemodialysis patients. We report the ADVANCE Study design and baseline subject characteristics... CONCLUSIONS: Subjects enrolled in ADVANCE have extensive CAC at baseline. The ADVANCE Study should help determine whether cinacalcet attenuates progression of vascular calcification.
Clinical Trials Related to Sensipar (Cinacalcet)
Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Subjects With PHPT Unable to Undergo Parathyroidectomy [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.
Pediatric Chronic Kidney Disease Safety and Efficacy [Recruiting]
The purpose of this study is to show that adding cinacalcet to the current treatment of
Secondary Hyperparathyroidism in children currently receiving dialysis will lower the
parathyroid hormone in a larger number of subjects compared to a program that does not
include cinacalcet.
Evaluation of a Cincalcet Suppression Test [Recruiting]
The aim of the study is to compare the results of a parathyroid hormone (PTH)suppression
test using a single oral tablet of cinacalcet in two groups of subjects: 1- a group of
healthy adults in whom the results of the test with cinacalcet will be compared with those
of the standardized PTH suppression test with intravenous calcium loading; 2- a group of
patients with proven primary hyperparathyroidism in whom the results of the test with
cinacalcet will be compared with those obtained during the same test, in healthy controls.
Cinacalcet in Paediatric Secondary Hyperparathyroidism (SHPT) Due to Chronic Kidney Disease (CKD) [Recruiting]
Twelve-month, multicenter, intra-subject controlled (retrospective-prospective), open-label,
active-treatment study to evaluate the dose-response and pharmacokinetics (PK) of cinacalcet
HCl for the treatment of Secondary Hyperparathyroidism (SHPT) in paediatric subjects with
chronic kidney disease (CKD) on dialysis, followed by 12-month study extension.
Safety & Tolerability of Cinacalcet in Pediatric Subjects With Chronic Kidney Disease & Secondary Hyperparathyroidism [Recruiting]
This is a multicenter, 26-week, single-arm, open-label, safety study. Subjects will remain
on study for 26 weeks or until time of kidney transplantation, whichever comes first. All
subjects, in addition to receiving cinacalcet, will receive standard of care, which may
include vitamin D sterols (25 OH vitamin D and/or 1-25 OH vitamin D and its analogs).
Reports of Suspected Sensipar (Cinacalcet) Side Effects
Hospitalisation (19),
Death (16),
Enteral Nutrition (14),
Blood Parathyroid Hormone Increased (13),
Nausea (12),
Gastrointestinal Tube Insertion (10),
Dyspnoea (9),
Convulsion (9),
Blood Calcium Decreased (8),
Tremor (8), more >>
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