Amgen: Hyperparathyroidism, Secondary trials

The registry lists 34 Hyperparathyroidism, Secondary studies with Amgen as lead sponsor. 2 are open to participants now and 22 have results posted.

Phase 1 4Phase 2 5Phase 3 17Phase 4 6No phase 2(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving HemodialysisRecruitingNCT03969329Phase 3
• A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on HemodialysisRecruitingNCT03633708Phase 3
• Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)CompletedNCT03299244Phase 3Results posted
• A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416CompletedNCT03283098Phase 1Results posted
• A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving HaemodialysisCompletedNCT02833857Phase 1Results posted
• Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on DialysisCompletedNCT02341417Phase 3Results posted
• Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on DialysisTerminatedNCT02138838Phase 3Results posted
• Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on HemodialysisCompletedNCT02102204Phase 3Results posted
• Pharmacokinetics and Excretion of [¹⁴C]Etelcalcetide (AMG 416) in Patients With End Stage Renal Disease (ESRD) Receiving DialysisCompletedNCT02054572Phase 1Results posted
• Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to EtelcalcetideCompletedNCT01932970Phase 3Results posted
• Head-to-Head Study of Etelcalcetide (AMG 416) and CinacalcetCompletedNCT01896232Phase 3Results posted
• Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on HemodialysisCompletedNCT01788046Phase 3Results posted
• Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on HemodialysisCompletedNCT01785875Phase 3Results posted
• Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on HemodialysisCompletedNCT01785849Phase 3Results posted
• Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary HyperparathyroidismTerminatedNCT01439867Phase 2Results posted
• Study to Evaluate Cinacalcet in Children With Chronic Kidney DiseaseCompletedNCT01290029Phase 1Results posted
• Pediatric Chronic Kidney Disease Safety and EfficacyTerminatedNCT01277510Phase 3Results posted
• Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing HemodialysisCompletedNCT01181531Phase 4Results posted
• 20070360 Incident DialysisCompletedNCT00803712Phase 4Results posted
• A Study of Cinacalcet to Improve Achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With End Stage Renal Disease (ESRD)CompletedNCT00431496Phase 4Results posted
• ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving HemodialysisCompletedNCT00379899Phase 4Results posted
• E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular EventsCompletedNCT00345839Phase 3Results posted
• Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal DiseaseCompletedNCT00261950Phase 2Results posted
• Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency PatientsCompletedNCT00042432Phase 2Results posted
• Post Transplant StudyCompletedNCT00395902
• A Multi-Center, Observational Registry of Subjects With Secondary Hyperparathyroidism (HPT) and Chronic Kidney Disease (CKD)CompletedNCT00189501
• ACHIEVE: Optimizing the Treatment of Secondary HyperparathyroidismCompletedNCT00135304Phase 4
• START: Sensipar Treatment Algorithm to Reach K/DOQI Targets in Chronic Kidney Disease Subjects With Secondary HyperparathyroidismCompletedNCT00132431Phase 4
• SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary HyperparathyroidismCompletedNCT00117052Phase 3
• Research Study Evaluating Cinacalcet for Patients With End Stage Renal Disease (ESRD)CompletedNCT00113945Phase 2
• Treatment for Patients With Secondary Hyperparathyroidism of End-Stage Renal Disease (ESRD)CompletedNCT00110929Phase 2
• Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving DialysisCompletedNCT00094484Phase 3
• A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Patients on DialysisCompletedNCT00042653Phase 3
• A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis PatientsCompletedNCT00037635Phase 3