17 completed, 2 recruiting, 1 terminated. 9 Phase 3, 6 Phase 2, 5 Phase 1.
By phase and status
Follow etelcalcetide hydrochloride: new trials by email Literature Review of etelcalcetide hydrochloride trials Research Report on etelcalcetide hydrochloride
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|
MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease
MT1013, Etelcalcetide Hydrochloride, Placebo - Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis | Phase 2 | Completed | Shaanxi Micot Pharmaceutical Technology Co., Ltd. | 115 | 2024-11-04 | 2026-07-22 |
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
Etelcalcetide - Secondary Hyperparathyroidism | Phase 3 | Recruiting | Amgen | 24 | 2019-12-20 | 2026-08-21 |
A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients
Etelcalcetide - End Stage Renal Disease | Phase 2 | Completed | Prim. Priv. Doz. Dr. Daniel Cejka | 37 | 2019-05-01 | 2022-03-23 |
A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Etelcalcetide, Standard of Care - Secondary Hyperparathyroidism, Chronic Kidney Disease | Phase 3 | Recruiting | Amgen | 56 | 2019-04-29 | 2026-02-27 |
The Effect of Etelcalcetide on CKD-MBD
Etelcalcetide - Chronic Kidney Disease Mineral and Bone Disorder, Renal Osteodystrophy | Phase 2 | Completed | Thomas Nickolas, MD MS | 22 | 2018-09-06 | 2023-09-21 |
Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)
Etelcalcetide, Cinacalcet - Secondary Hyperparathyroidism, Chronic Kidney Disease | Phase 3 | Completed | Amgen | 637 | 2018-05-15 | 2021-04-30 |
A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416
Etelcalcetide, Placebo - Secondary Hyperparathyroidism | Phase 1 | Completed | Amgen | 33 | 2018-03-01 | 2020-02-10 |
A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis
Etelcalcetide - Chronic Kidney Disease, Secondary Hyperparathyroidism | Phase 1 | Completed | Amgen | 11 | 2017-03-14 | 2019-07-10 |
Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
Etelcalcetide - Hyperparathyroidism, Secondary | Phase 3 | Completed | Amgen | 902 | 2014-03-25 | 2017-11-17 |
Pharmacokinetics and Excretion of [¹⁴C]Etelcalcetide (AMG 416) in Patients With End Stage Renal Disease (ESRD) Receiving Dialysis
[¹⁴C]Etelcalcetide - Secondary Hyperparathyroidism in Patients With ESRD on Hemodialysis | Phase 1 | Completed | Amgen | 6 | 2014-02-07 | 2018-08-31 |
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
Etelcalcetide, Cinacalcet, Oral Placebo - Secondary Hyperparathyroidism, Chronic Kidney Disease | Phase 3 | Completed | Amgen | 683 | 2013-08-13 | 2019-07-18 |
Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
Etelcalcetide - Hyperparathyroidism, Secondary | Phase 3 | Completed | Amgen | 158 | 2013-08-12 | 2018-10-17 |
Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
Etelcalcetide - Hyperparathyroidism, Secondary | Phase 3 | Completed | Amgen | 891 | 2013-07-31 | 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
Etelcalcetide, Placebo - Hyperparathyroidism, Secondary | Phase 3 | Completed | Amgen | 508 | 2013-03-12 | 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
Etelcalcetide, Placebo - Hyperparathyroidism, Secondary | Phase 3 | Completed | Amgen | 515 | 2013-03-12 | 2019-08-20 |
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
Etelcalcetide - Secondary Hyperparathyroidism | Phase 2 | Terminated | KAI Pharmaceuticals | 30 | 2012-03-01 | 2017-04-13 |
Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
Etelcalcetide - Secondary Hyperparathyroidism | Phase 2 | Completed | KAI Pharmaceuticals | 37 | 2011-12-05 | 2017-04-11 |
Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
Etelcalcetide, Placebo - Secondary Hyperparathyroidism | Phase 2 | Completed | KAI Pharmaceuticals | 87 | 2011-02-20 | 2017-04-13 |
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
Placebo, Etelcalcetide - Hyperparathyroidism, Secondary | Phase 1 | Completed | KAI Pharmaceuticals | 28 | 2010-09-07 | 2018-01-02 |
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers
Etelcalcetide, Placebo - Hyperparathyroidism, Secondary | Phase 1 | Completed | KAI Pharmaceuticals | 32 | 2010-06-09 | 2017-04-14 |
Conditions studied
Hyperparathyroidism, Secondary (17) · Renal Insufficiency, Chronic (10) · Hypocalcemia (4) · Chronic Kidney Disease-Mineral and Bone Disorder (3) · Kidney Failure, Chronic (2) · Bone Diseases (1) · Hyperparathyroidism (1) · Kidney Diseases (1) · Neoplasm Metastasis (1) · Vascular Calcification (1)
Sponsors
Amgen (12) · KAI Pharmaceuticals (5) · Prim. Priv. Doz. Dr. Daniel Cejka (1) · Shaanxi Micot Pharmaceutical Technology Co., Ltd. (1) · Thomas Nickolas, MD MS (1)
Countries
United States (12) · Belgium (7) · Germany (7) · Poland (7) · Australia (6) · Czechia (6) · France (6) · Hungary (6) · Italy (6) · Russia (6) · Spain (6) · Austria (5) · Canada (5) · Israel (4) · Lithuania (4)
Top investigators
M D (3) · Gregory Bell, MD (2) · Daniel Cejka, Md (1) · Thomas Nickolas, MD, MS (1)
Results publications
PMID 30859218, PMID 32647975, PMID 34774334, PMID 37574661
NIH funding
2015 (1), 2017 (1)