9 completed, 1 terminated. 8 Phase 2, 3 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 8 | Completed 7, Terminated 1 |
| Phase 1 | 3 | Completed 3 |
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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 |
|---|---|---|---|---|---|---|
| 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 |
| Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Postherpetic Neuralgia Placebo, KAI-1678, Lidocaine - Postherpetic Neuralgia | Phase 2 | Completed | KAI Pharmaceuticals | 23 | 2009-03-01 | 2025-09-02 |
| Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Spinal Cord Injury Placebo, KAI-1678 - Spinal Cord Injury | Phase 2 | Completed | KAI Pharmaceuticals | 5 | 2009-03-01 | 2025-09-02 |
| Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain Placebo, KAI-1678, Ketorolac Tromethamine - Pain, Postoperative | Phase 2 | Completed | KAI Pharmaceuticals | 90 | 2008-12-01 | 2011-09-02 |
| Safety and Efficacy Study of KAI-9803 to Treat Subjects With ST Elevation Myocardial Infarction [Heart Attack] KAI-9803 - Myocardial Infarction, Cardiovascular Diseases | Phase 2 | Completed | KAI Pharmaceuticals | 1180 | 2008-11-01 | 2011-09-02 |
| Safety of KAI-9803 for Injection With Angioplasty Following Heart Attack KAI-9803 for Injection, Placebo - Myocardial Infarction | Phase 1 / Phase 2 | Completed | KAI Pharmaceuticals | 154 | 2004-09-01 | 2011-09-02 |
Hyperparathyroidism, Secondary (5) · Pain, Postoperative (3) · Chronic Kidney Disease-Mineral and Bone Disorder (2) · Myocardial Infarction (2) · Pain (2) · Cardiovascular Diseases (1) · Heart Diseases (1) · Infarction (1) · Myocardial Ischemia (1) · Neuralgia, Postherpetic (1) · Pathologic Processes (1) · Spinal Cord Injuries (1)
etelcalcetide hydrochloride (5) · KAI-1678 (3) · KAI 9803 (2) · Bulk Drugs (1) · Injections (1) · Ketorolac (1) · Ketorolac Tromethamine (1) · Lidocaine (1)
Australia (5) · United States (4) · New Zealand (2) · Belgium (1) · Canada (1) · Czechia (1) · Denmark (1) · Finland (1) · Germany (1) · Hungary (1) · Israel (1) · Italy (1) · Netherlands (1) · Norway (1) · Poland (1)
Gregory Bell, MD (6) · M D (3) · A.Michael Lincoff, MD (1)