Sensipar®

Generic Name: Cinacalcet HCl
Study IDStudied Indication or DiseasePhaseStudy TitleSynopsis
20000178Chronic Kidney Disease Subjects with Secondary Hyperparathyroidism3A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Chronic Kidney Disease Subjects with Secondary Hyperparathyroidism Not Receiving Dialysis.
20000204Parathyroid carcinoma or intractable primary hyperparathyroidism (HPT)2

An Assessment of the Calcimimetic Agent AMG 073 for the Treatment of Subjects With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism

20010239Secondary hyperparathyroidism (HPT) in subjects with chronic renal insufficiency (CRI)2

A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of a Calcimimetic Agent (AMG 073) in Subjects with Secondary Hyperparathyroidism of Chronic Renal Insufficiency

20020158Secondary hyperparathyroidism (HPT) in end-stage renal disease (ESRD) subjects on maintenance hemodialysis or peritoneal dialysis2

A Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) When Two Different Vitamin D Regimens are Used in Subjects with Secondary Hyperparathyroidism of End-stage Renal Disease (ESRD)

20030187Secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) receiving maintenance dialysis3b

OPTIMA: An OPen-label, Randomised Study Using Cinacalcet To IMprove Achievement of K/DOQI Targets in Patients with ESRD

20030227Clinical Pharmacology1A Phase I, Open-Label, Non-Randomized, Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Cinacalcet HCl in Pediatric Subjects with Chronic Kidney Disease Receiving Dialysis
20040123Chronic Kidney Disease Subjects on Dialysis with Secondary Hyperparathyroidism4START - Sensipar® Treatment Algorithm to Reach K/DOQI™ Targets in Chronic Kidney Disease Subjects on Dialysis with Secondary Hyperparathyroidism.
20040143Secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD) on dialysis3b

SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients with Secondary Hyperparathyroidism

20040159Secondary Hyperparathyroidism (HPT) and Chronic Kidney Disease (CKD)Observational StudyA Multi-center, Observational Registry of Subjects with Secondary Hyperparathyroidism (HPT) and Chronic Kidney Disease (CKD).
20040196Secondary hyperparathyroidism (SHPT) in patients with ESRD on maintenance dialysis.4

A Study To Assess Achievement of NKF K/DOQI Targets Using Sensipar® (cinacalcet) in Australian Subjects With End Stage Renal Disease (ESRD) who are being treated with Aranesp® for anaemia management.

20040261Secondary Hyperparathyroidism in Renal Transplant RecipientsObservational StudyA Retrospective Evaluation of Sensipar® Use in Renal Transplant Recipients.
20050102Secondary Hyperparathyroidism4ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism: A Comparison of Cinacalcet and Low Dose Vitamin D vs. Escalating Doses of Vitamin D Alone.
20050104Secondary hyperparathyroidism (HPT) in subjects with CKD receiving dialysis.2

Bone Histomorphometry Assessment For Dialysis Patients with Secondary Hyperparathyroidism of End Stage Renal Disease

20050182Secondary hyperparathyroidism (HPT) in subjects with chronic kidney disease (CKD) receiving maintenance hemodialysis.3

EVOLVE - Evaluation Of Cinacalcet HCI Therapy to Lower Cardiovascular Events.

20060111Secondary hyperparathyroidism (HPT) in subjects with CKD receiving hemodialysis4

ADVANCE: A Randomized Study to Evaluate the Effects of Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects with Chronic Kidney Disease (CKD) Receiving Hemoialysis

20062007Renal transplant recipients with hypercalcemia and autonomous hyperparathyroidism3

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ussing Cinacalcet to Correct Hypercalcemia in Renal Transplant Recipients With Autonomous Hyperparathyroidism

20070208Secondary hyperparathyroidism (SHPT) in pediatric subjects with chronic kidney disease (CKD) receiving hemodialysis (HD) or peritoneal dialysis (PD)3Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects with Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Dialysis
20070277Hypercalcemia in Subjects With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy3

A Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Cinacalcet for the Treatment of  Hypercalcemia in Subjects With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy

20070293Secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and for the treatment of hypercalcemia in patients with parathyroid carcinoma.1An Open-label, Randomized, Single-dose, 3-period, 3-treatment Crossover Study to Assess the Comparative Bioavailability of 5mg Cinacalcet Capsules to the 30mg Commercial Formulation Cinacalcet Tablets in Healthy Adult Volunteers
20070360Treatment of secondary hyperparathyroidism (SHPT)4

Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis

20070363Primary HyperparathyroidismObservational study.
PRIMARA: A Prospective Descriptive Observational Study to Review Mimpara® (Cinacalcet) Use in Patients With Primary Hyperparathyroidism in Clinical Practice.
20080093Persistent Hyperparathyroidism in Kidney Transplant RecipientsObservational StudyA Prospective Cohort Study to Describe the Evolution of Persistent Hyperparathyroidism in Kidney Transplant Recipients.
20090198Secondary hyperparathyroidism (HPT) in pediatric subjects with chronic kidney disease (CKD) receiving dialysis.Observational StudyA Retrospective Observational Study to Describe Changes in Biochemical Markers and Occurrence of Safety Events Following Treatment with Cinacalcet HCl in Pediatric Subjects with Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Dialysis.
20090686Secondary hyperparathyroidism4

A Multicenter, Randomized, Open Label Study to Compare the Efficacy of Cinacalcet versus Traditional Vitamin D Therapy for Management of Secondary Hyperparathyroidism Among Subjects Undergoing Hemodialysis

20110100The treatment of secondary hyperparathyroidism (SHPT) in pediatric subjects with chronic kidney disease (CKD) receiving hemodialysis (HD) or peritoneal dialysis (PD)2An Open-label, Single-arm Study to Assess the Safety and Tolerability of Cinacalcet HCl in Addition to Standard of Care in Pediatric Subjects Age 28 Days to <6 years With Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Dialysis
20130356Management of secondary hyperparathyroidism (SHPT) in pediatric subjects with chronic kidney disease (CKD) receiving dialysis.3A Randomized, Open-label, Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis
20140159Management of secondary hyperparathyroidism in pediatric subjects with chronic kidney disease (CKD) receiving dialysis3A Multicenter Single-arm Extension Study to Characterize the Long-term Safety of Cinacalcet Hydrochloride in the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects With Chronic Kidney Disease on Dialysis
20160428Healthy adult volunteers1An Open-label, Randomized, Single-dose, 2-Period, 2-Treatment Crossover Study to Assess the Bioequivalence of Cinacalcet Capsule (Administered as Six of the 5-mg Cinacalcet Capsules) With 30-mg Commercial Cinacalcet Tablet in Healthy Adult Volunteers.