Parsabiv™

Generic Name: etelcalcetide
Study IDStudied Indication or DiseasePhaseStudy TitleSynopsis
20120229secondary hyperparathyroidism (SHPT) in subjects with chronic kidney disease (CKD) on hemodialysis3Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis
20120230secondary hyperparathyroidism (SHPT) in subjects with chronic kidney disease (CKD) on hemodialysis3A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis
20120231secondary hyperparathyroidism (SHPT) in subjects with chronic kidney disease (CKD) on hemodialysis3Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis
20120330Secondary Hyperparathyroidism2aA Double-blind, Randomized, Placebo-controlled Multiple Ascending Dose Study to Assess the Safety, Tolerability and Efficacy of KAI-4169 in Hemodialysis Subjects With Secondary Hyperparathyroidism
20120331Chronic Kidney Disease-Mineral2A Single-arm, Open-label, Multicenter, Dose Titration Study of KAI-4169 to Treat Secondary Hyperparathyroidism in Hemodialysis Subjects with Chronic Kidney Disease-Mineral and Bone Disorder
20120334Secondary Hyperparathyroidism2A Multicenter Open-label Extension Study to Assess the Long-term Safety and Efficacy of KAI-4169 (also known as AMG 416) in the Treatment of Chronic Kidney Disease-Mineral and Bone Disorder in Patients with Secondary Hyperparathyroidism
20120359secondary hyperparathyroidism (SHPT) in subjects with chronic kidney disease (CKD) on hemodialysis3A Multicenter, Multiple-dose, Single-arm Study to Switch Hemodialysis Subjects With Secondary Hyperparathyroidism From Oral Cinacalcet HCl to Intravenous AMG 416
20120360secondary hyperparathyroidism (SHPT) in subjects with chronic kidney disease (CKD) on hemodialysis3A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in Hemodialysis Subjects With Secondary Hyperparathyroidism
20130107Healthy Male Volunteers1A Double-Blind, Randomized, Placebo-Controlled, Rising Single Intravenous Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of KAI-4169 in Healthy Male Volunteers
20130139Secondary Hyperparathyroidism1bA Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Tolerability of Single Ascending Doses of KAI-4169 in Hemodialysis Subjects with Secondary Hyperparathyroidism
20130147Secondary hyperparathyroidism in patients with ESRD on hemodialysis1An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Biotransformation and Excretion of [14C]AMG 416 in Patients with End Stage Renal Disease Receiving Dialysis
20130213secondary hyperparathyroidism (SHPT) in subjects with chronic kidney disease (CKD) on hemodialysis3A Multicenter Single-arm Extension Study to Describe the Long-term Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis