Etelcalcetide
Sponsors
Jinken Clinic, KAI Pharmaceuticals, Amgen, Prim. Priv. Doz. Dr. Daniel Cejka, Thomas Nickolas, MD MS
Conditions
Chronic Kidney DiseaseChronic Kidney Disease Mineral and Bone DisorderChronic Kidney Disease, Secondary HyperparathyroidismEnd Stage Renal DiseaseHyperparathyroidism, SecondaryHyperparathyroidism; Secondary, RenalRenal OsteodystrophySecondary Hyperparathyroidism
Phase 1
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
CompletedNCT01134562
Start: 2010-09-07End: 2011-04-02Updated: 2018-01-02
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers
CompletedNCT01134549
Start: 2010-06-09End: 2010-07-31Updated: 2017-04-14
A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis
CompletedNCT02833857
Start: 2017-03-14End: 2018-10-31Updated: 2019-07-10
A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416
CompletedNCT03283098
Start: 2018-03-01End: 2019-02-04Updated: 2020-02-10
Phase 2
Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
CompletedNCT01254565
Start: 2011-02-20End: 2011-08-24Updated: 2017-04-13
Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
CompletedNCT01414114
Start: 2011-12-05End: 2012-05-21Updated: 2017-04-11
Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG 416 or KAI-4169) in Patients With Secondary Hyperparathyroidism
TerminatedNCT01576146
Start: 2012-03-31End: 2014-05-01Updated: 2017-04-13
A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients
CompletedNCT03795558
Start: 2019-05-01End: 2022-03-01Updated: 2022-03-23
The Effect of Etelcalcetide on CKD-MBD
CompletedNCT03960437
Start: 2018-09-06End: 2020-11-19Updated: 2023-09-21
Phase 3
Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
CompletedNCT01785875
Start: 2013-07-31End: 2015-07-01Updated: 2019-04-10
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
CompletedNCT01785849
Start: 2013-03-12End: 2014-06-12Updated: 2019-08-26
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
CompletedNCT01788046
Start: 2013-03-12End: 2014-05-09Updated: 2019-08-20
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
CompletedNCT01896232
Start: 2013-08-13End: 2015-01-08Updated: 2019-07-18
Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
CompletedNCT01932970
Start: 2013-08-12End: 2017-02-14Updated: 2018-10-17
Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
CompletedNCT02102204
Start: 2014-03-25End: 2017-06-26Updated: 2017-11-17
Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)
CompletedNCT03299244
Start: 2018-05-15End: 2020-04-08Updated: 2021-04-30
A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
RecruitingNCT03633708
Start: 2019-04-29End: 2029-01-31Target: 56Updated: 2026-02-27
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
RecruitingNCT03969329
Start: 2019-12-20End: 2027-06-30Target: 24Updated: 2026-08-21