Success Metrics

Clinical Success Rate
93.8%

Based on 15 completed trials

Completion Rate
94%(15/16)
Active Trials
2(11%)
Results Posted
100%(15 trials)
Terminated
1(6%)

Phase Distribution

Ph phase_3
9
50%
Ph phase_2
5
28%
Ph phase_1
4
22%

Phase Distribution

4

Early Stage

5

Mid Stage

9

Late Stage

Phase Distribution18 total trials
Phase 1Safety & dosage
4(22.2%)
Phase 2Efficacy & side effects
5(27.8%)
Phase 3Large-scale testing
9(50.0%)

Highest Phase Reached

Phase 3

Trial Status & Enrollment

Completion Rate

93.8%

15 of 16 finished

Non-Completion Rate

6.3%

1 ended early

Currently Active

2

trials recruiting

Total Trials

18

all time

Status Distribution
Active(2)
Completed(15)
Terminated(1)

Detailed Status

Completed15
Recruiting2
Terminated1

Development Timeline

Analytics

Development Status

Total Trials
18
Active
2
Success Rate
93.8%
Most Advanced
Phase 3

Trials by Phase

Phase 14 (22.2%)
Phase 25 (27.8%)
Phase 39 (50.0%)

Trials by Status

completed1583%
terminated16%
recruiting211%

Recent Activity

Clinical Trials (18)

Showing 18 of 18 trials
NCT03969329Phase 3

A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis

Recruiting
NCT03633708Phase 3

A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

Recruiting
NCT03960437Phase 2

The Effect of Etelcalcetide on CKD-MBD

Completed
NCT03795558Phase 2

A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients

Completed
NCT03299244Phase 3

Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)

Completed
NCT03283098Phase 1

A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416

Completed
NCT01785849Phase 3

Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis

Completed
NCT01788046Phase 3

Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

Completed
NCT01896232Phase 3

Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet

Completed
NCT02833857Phase 1

A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis

Completed
NCT01785875Phase 3

Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

Completed
NCT01932970Phase 3

Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide

Completed
NCT01134562Phase 1

Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism

Completed
NCT02102204Phase 3

Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis

Completed
NCT01134549Phase 1

Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers

Completed
NCT01576146Phase 2

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

Terminated
NCT01254565Phase 2

Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism

Completed
NCT01414114Phase 2

Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder

Completed

All 18 trials loaded

Drug Details

Intervention Type
DRUG
Total Trials
18