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Sensipar Medical Research Studies

Up-to-date List of Sensipar Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Sensipar Medical Research Studies

Rank Status Study
1 Unknown  Cinacalcet in Paediatric Secondary Hyperparathyroidism (SHPT) Due to Chronic Kidney Disease (CKD)
Condition: Secondary Hyperparathyroidism
Intervention: Drug: Cinacalcet HCl
Outcome Measures: Composite EP, e.g. the proportion of patients who will have a reduction from baseline of >= 25% in mean iPTH levels with concomitant values for plasma P <6 mg/dL and Ca between 8.4 and 10.5 mg/dL or the Ca x P product <60;   The long term control of iPTH level < 300 pg/mL;   The long term control of PTH, Ca, P, and the Ca x P product values;   The PK/ PD ( iPTH and testosterone) profile at individual patient level;   The long term auxological indices and patient growth velocity during cinacalcet treatment;   The proportion of patients with treatment-emergent adverse events (AEs), serious AEs (SAEs), and laboratory abnormalities over long term
2 Recruiting Safety & Tolerability of Cinacalcet in Pediatric Subjects With Chronic Kidney Disease & Secondary Hyperparathyroidism
Conditions: Chronic Kidney Disease;   Hyperparathyroidism, Secondary
Intervention: Drug: Cinacalcet HCl
Outcome Measures: Occurrence of corrected serum calcium levels < 9.0 mg/dL (2.25 mmol/L) forages 28 days to < 2 years, and < 8.4 mg/dL (2.1 mmol/L) for ages ≥ 2 to < 6 years during the study;   Occurrence of corrected serum calcium < 8.8 mg/dL (2.2 mmol/L) during the study;   PK parameters at week 12 (eg, maximum plasma concentration (Cmax), area under the curve (AUC), apparent clearance (CL/F), apparent volume of distribution (V/F));   The percent change of plasma iPTH, corrected total serum calcium, serum phosphorous, and Ca x P from baseline to scheduled visits during the study;   Achievement of ≥ 30% reduction from baseline in plasma iPTH during the study;   Achievement of plasma iPTH values between 200 and 300 pg/mL (21.2 and 31.8 pmol/L) at any two consecutive measurements;   Achievement of plasma iPTH values < 300 pg/mL (31.8 pmol/L) during the study
3 Recruiting Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant
Conditions: Hypophosphatemia;   Renal Transplant
Interventions: Drug: Cinacalcet;   Drug: Placebo
Outcome Measure: improvement in serum phosphorus
4 Not yet recruiting A Study to Assess the Efficacy and Safety of Cinacalcet in Pediatric Subjects With SHPT and CKD on Dialysis
Condition: Chronic Kidney Disease, Secondary Hyperparathyroidism
Interventions: Drug: Cinacalcet HCl;   Dietary Supplement: Standard of Care
Outcome Measures: Achievement of a ≥ 30% reduction from baseline in mean plasma iPTHduring the efficacy assessment period (EAP), defined as Week 17 - 20;   Achievement of a mean iPTH ≤ 300 pg/mL (31.8 pmol/L) during the EAP;   Percent change in iPTH from baseline to the mean value during the EAP;   Change in corrected total serum calcium from baseline to the mean value during the EAP;   Change in serum phosphorus from baseline to the mean value during the EAP
5 Recruiting Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients
Conditions: Kidney Failure;   Secondary Hyperparathyroidism;   Vascular Diseases
Intervention: Drug: Cinacalcet
Outcome Measures: Change in coronary artery calcium score and heart valve calcium score;   Change in aortic pulse wave velocity;   change in parathyroid gland size (cinacalcet treatment arm only);   change in left ventricular mass index;   change in left ventricular volume and function;   change in bone mineral density at forearm, spine and femur;   change in insulin resistance index;   Change in subjective global assessment;   change in lean muscle mass;   change in resting energy expenditure;   change in intact parathyroid hormone (iPTH) level
6 Unknown  Effect of Cinacalcet on Parathyroid Hormone Secretion in Children and Adolescents With Hypophosphatemic Rickets
Condition: Hypophosphatemic Rickets, X-Linked Dominant
Intervention: Drug: Cinacalcet
Outcome Measures: The primary outcome will be the effect of cinacalcet on serum PTH.;   Secondary outcome will be the effect of the calcimimetic on mineral homeostasis; ionized calcium, total calcium, and phosphate will be measured.
7 Unknown  Interaction Between a Calcimimetic Agent and the Renin Angiotensine Aldosterone System
Condition: Relationship Between Calcimimetic and the RAAS
Interventions: Drug: calcimimetic agent (cinacalcet);   Drug: placebo
Outcome Measures: Effect of cinacalcet compared to placebo on plasma renin activity;   effect of cinacalcet administered as single dose (compared to placebo) on plasma aldosterone and on hemodynamics
8 Unknown  Nicotinamide Versus Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients
Conditions: Chronic Renal Failure;   Hemodialysis
Interventions: Drug: nicotinamide;   Drug: sevelamer;   Drug: cinacalcet
Outcome Measures: The comparison between nicotinamide and Sevelamer was primarily to demonstrate the noninferiority of nicotinamide in terms of control of the phosphatemia observed during the 4th, 5th and 6th months before to introduce Cinacalcet ®.;   To demonstrate noninferiority of nicotinamide in terms of effect on dyslipidemia (evaluated by the ratio LDL / HDL cholesterol), the risk of hypercalcemia (PCa> 2.37 mmol / l) and increase of phospho-calcic product (> 3 , 79 mmol/l).;   To evaluate the difference between nicotinamide and sevelamer on vascular calcification;   To evaluate the difference between nicotinamide and sevelamer on bone mass loss and fracture risk;   Evaluate the percentage of population requiring use of cinacalcet® to control PTH (75-300 pg/ml). Evaluate his benefit on phosphatemia and calcemia control. Prevent the need for surgical PTX, and evaluate the additional cost of treatment by cinacalcet;   Evaluate roles of metabolites of nicotinamide (efficacy and side effects) through another study;   Compare the cost-effectiveness ratio of these two treatments
9 Recruiting Cinacalcet for Fibroblast Growth Factor 23 (FGF23)-Mediated Hypophosphatemia (Hypophosphatemic Rickets)
Condition: Osteomalacia
Intervention: Drug: Osteomalacia
Outcome Measures: Evaluate the tolerability of cinacalcet in individuals with FGF23-mediated hypophosphatemia;   To explore the effectiveness of cinacalcet at decreaing renal phosphate wasting;   Evaluate the pharmacodynamics of cinacalcet in this subject population.
10 Recruiting A Study to Evaluate the Effect of ASP7991 in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis
Condition: Secondary Hyperparathyroidism
Interventions: Drug: ASP7991;   Drug: Cinacalcet;   Drug: Placebo
Outcome Measures: Serum iPTH concentration;   Corrected serum Ca, Phosphate(P) concentration;   serum vitamin D concentration;   serum wPTH concentration;   Serum concentration of bone metabolism markers;   Serum FGF23 concentration;   Safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs

These studies may lead to new treatments and are adding insight into Sensipar etiology and treatment.

A major focus of Sensipar research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.

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