Hyperparathyroidism, Secondary Clinical Trial
Official title:
A 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
This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.
This is a multicenter, single-arm, extension study in which adults with secondary hyperparathyroidism currently receiving hemodialysis and previously treated in Amgen studies 20120231 (NCT01785875), 20120334 (NCT01576146), or 20120360 (NCT01896232) will continue to be treated with etelcalcetide until approximately 2.5 years after the first participant was enrolled. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01134562 -
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
|
Phase 1 | |
| Completed |
NCT02523209 -
Analysis of Bone Microarchitecture With HR-pQCT of Patients With Chronic Kidney Disease (CKD) Candidates for Renal Transplantation
|
N/A | |
| Completed |
NCT01922843 -
A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis
|
Phase 2 | |
| Completed |
NCT01651000 -
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
|
Phase 3 | |
| Completed |
NCT00528788 -
How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis
|
Phase 4 | |
| Completed |
NCT01181531 -
Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis
|
Phase 4 | |
| Completed |
NCT05382988 -
Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy
|
Phase 3 | |
| Completed |
NCT02056730 -
The Study of Efficacy and Safety of REGPARA Drug in Dialysis Patients Have High Blood Levels of Parathyroid
|
Phase 4 | |
| Completed |
NCT01704079 -
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
|
Phase 3 | |
| Completed |
NCT00397475 -
Evaluation of Colecalciferol Substitution in Dialysis Patients
|
N/A | |
| Withdrawn |
NCT03063190 -
Cholecalciferol Supplementation in Restless Leg Syndrome in Patients With Chronic Kidney Disease
|
Phase 4 | |
| Recruiting |
NCT02273570 -
Optimal Anemia Treatment in End Stage Renal Disease (ERSD)
|
N/A | |
| Completed |
NCT01785849 -
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
|
Phase 3 | |
| Completed |
NCT01788046 -
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
|
Phase 3 | |
| Terminated |
NCT01277510 -
Pediatric Chronic Kidney Disease Safety and Efficacy
|
Phase 3 | |
| Terminated |
NCT01439867 -
Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism
|
Phase 2 | |
| Completed |
NCT01134549 -
Safety, Tolerability and Pharmacokinetics of KAI-4169 in Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT01785875 -
Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
|
Phase 3 | |
| Active, not recruiting |
NCT02464072 -
Subtotal Parathyroidectomy or Total Parathyroidectomy With Autograft in Chronic Kidney Disease Patients Under Dialysis
|
N/A | |
| Completed |
NCT01290029 -
Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease
|
Phase 1 |