KINEVAC SUMMARY
KINEVAC®
Sincalide for Injection
Kinevac (Sincalide for Injection) is a cholecystopancreatic-gastrointestinal hormone peptide for parenteral administration. The agent is a synthetically-prepared C-terminal octapeptide of cholecystokinin. Each vial of sincalide provides a sterile nonpyrogenic lyophillized white powder consisting of 5 mcg sincalide with 170 mg mannitol, 30 mg arginine hydrochloride, 15 mg lysine hydrochloride, 9 mg potassium phosphate dibasic, 4 mg methionine, 2 mg pentetic acid, 0.04 mg sodium metabisulfite, and 0.005 mcg polysorbate 20. The pH is adjusted to 6.0 - 8.0 with hydrochloric acid and/or sodium hydroxide prior to lyophilization.
Kinevac (Sincalide) is indicated for the following:
Kinevac (Sincalide for Injection) may be used: (1) to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; (2) to stimulate pancreatic secretion (especially in conjunction with secretin) prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; (3) to accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract.
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NEWS HIGHLIGHTS
Clinical Trials Related to Kinevac (Sincalide)
Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying [Recruiting]
This is a clinical research study to establish normal values for the infusion of a synthetic
form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is
released from the small bowel to stimulate the pancreas and gallbladder to help digest and
absorb food. Some people have gallbladder problems and need to be tested with the synthetic
cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out
how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying.
The findings in normal subjects will be used to establish normal values that can then be
compared with patients with suspected gallbladder disease.
Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis [Completed]
OBJECTIVES: I. Compare conjugated bilirubin levels and serum bile acid levels in severely
premature newborns on long term parenteral nutrition and given either sincalide or placebo.
II. Compare morbidity and mortality rates in this patient population. III. Evaluate
ultrasonographic images of the hepatobiliary tree during and 1 to 2 years after the
administration of sincalide or placebo to assess the development of biliary sludge and
biliary stone formation.
Thyroid Hormones Homeostasis and Energy Metabolism Changes During Stimulation of Endogenously Secreted Bile Acids (BAs) [Recruiting]
Postprandial thermogenesis, or thermic effect of food are terms that describe the increase
in utilization of energy by the human body following a meal. The mechanisms involved in this
process are believed to differ according to the type of food consumed, whether fat, protein
or carbohydrate.
The bile acids (BAs), unique substances secreted by the gall bladder into the gut after a
meal, play an important role in the absorption of fat and the management of cholesterol
stores in the body. Recent studies suggest that BAs may also serve as regulators of energy
expenditure (consumption) in the cells of our body by increasing the production of T3, an
active form of thyroid hormone. T3 in turn is believed to increase the efficiency with which
our bodies burn calories thereby generating heat. Although this process has been shown to
be effective in rodents who demonstrated weight loss after treatment, the role of BAs in
humans is poorly understood. Thus we do not know whether endogenous (produced by the body)
or exogenous (taken as medication) BAs play a significant role in the maintenance of body
weight. We hypothesize that, similarly to rodents, humans will respond to BAs by increasing
energy expenditure via the production of the active form of thyroid hormone.
This randomized, cross-over study will look at changes in thyroid hormones and energy
consumption in response to stimuli of endogenous BA secretion including dietary content, and
to the intake of pharmacological doses of bile acids.
Following a two-day period of equilibration diet, 30 healthy volunteers will be randomly
assigned to receive either a high-fat or high-carbohydrate isocaloric meal followed by a
6-hour metabolic chamber stay; the next day they will be crossed-over to the alternate
intervention. During the following three days, the study subjects will again be randomized
to receive either an intravenous injection of sincalide (the C-terminal octapeptide fragment
of cholecystokinin) 0. 04 mcg/kg or placebo and P. O. placebo, or I. V. placebo and 15 mg/kg of
BA (ursodiol) with similar metabolic chamber stays and cross-over design.
The following parameters will be recorded and compared to placebo:
Energy expenditure
Substrate utilization
Spontaneous movements
Skin and core temperature
Serial changes in circulating thyroid hormones
Serial changes in bile acid serum concentrations
The data gathered from this study will provide greater insight into the physiological and
molecular mechanism(s) regulating the relation between endogenous bile acid secretion and
energy metabolism in response to meals, as well as the role of BAs per se on energy
metabolism.
Ultrasound for Diagnosis of Biliary Dyskinesia [Recruiting]
This is a prospective, non-randomized study of 50 people with suspected biliary dyskinesia.
The purpose of this study is to investigate if it is possible to use ultrasound to make a
diagnosis of a condition called biliary dyskinesia. The investigators null hypothesis is
that there will be no statistical difference between the proposed experimental test
(Ultrasound) and the HIDA scan (a nuclear medicine hepatobiliary system scan) in the
diagnosis of biliary dyskinesia.
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